Science and Technology 科学技術 Vol.19 / #Coronavirus #コロナウイルス Vol.22(pharmaceutical products 医薬品 Vol.8:drugs 治療薬)

All the below links and excerpts are in English.

Sarilumab (Kevzara®) に係るリンクと当方作成の抜粋を取り急ぎ以下のとおり貼っておきます。
cf.
Science and Technology 科学技術 Vol.14 / #Coronavirus #コロナウイルス Vol.15(pharmaceutical products 医薬品 Vol.6:drugs 治療薬) Tocilizumab
Science and Technology 科学技術 Vol.15 / #Coronavirus #コロナウイルス Vol.16(pharmaceutical products 医薬品 Vol.7:drugs 治療薬)

Clinicians encouraged to consider tocilizumab or sarilumab in treatment of hospitalised COVID-19 patients (07/01/2021) | @PJOnline_News,@robinson_julia
… The new advice, which is due to be published on 8 January 2020, follows results released from the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired pneumonia (REMAP-CAP), which suggested that tocilizumab and sarilumab, which are both IL-6 receptor antagonists, led to a 24% reduced risk of mortality, when administered to patients within 24 hours of entering intensive care. …
At the time of full analysis, 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to standard care. The majority of patients were also treated with corticosteroids, such as dexamethasone, and were receiving respiratory support.
The trial data yielded an odds ratio of 1.64 for a better outcome with tocilizumab, and 1.76 for sarilumab, compared to no immune modulation, with a high degree of statistical certainty.
…Anthony Gordon…
Gino Martini, chief scientist at the Royal Pharmaceutical Society…
Tocilizumab and sarilumab have already been added to the government’s export restriction list, which bans companies from buying medicines meant for UK patients and selling them on for a higher price in another country. This will protect supply for UK patients by enforcing regulatory action on those who flout the restrictions.

Roche’s Actemra, Regeneron’s Kevzara win U.K.’s favor in COVID-19 after study shows 24% drop in death risk (01/08/2021) | @FiercePharma,@arleneweintraub
The question of whether seriously ill COVID-19 patients can benefit from anti-inflammatories like Roche’s Actemra and Sanofi and Regeneron’s Kevzara has dogged practitioners in the United States thanks to conflicting clinical trial results.
The United Kingdom, on the other hand, has reached a definitive answer on the two drugs, both of which are IL-6 inhibitors: They significantly reduce the risk of death in COVID-19 patients needing intensive care, and they should be used to ease the pressure hospitals are now facing as the coronavirus pandemic continues to intensify, the country’s National Institute for Health Research (NIHR) said Thursday.
The recommendation came after data from an NIHR-sponsored study showed that Actemra and Kevzara can cut hospital stays for COVID-19 patients admitted to intensive care by 10 days and can lower the risk of death by 24% in patients who receive either drug within a day of admission. That finding prompted the U.K. government to recommend to the National Health Service (NHS) that IL-6 inhibitors be rolled out for the treatment of COVID-19. …

UK Covid patients to receive new drugs tocilizumab and sarilumab that reduce death risk by 24% (w Video; 01/08/2021) | @EveningStandard,@HattieBrewis
… NHS patients admitted to the country’s intensive care units will be able to receive tocilizumab and sarilumab, which have also been found to reduce the time coronavirus sufferers need to spend in hospital by up to 10 days. …
It comes after results from the Government-funded REMAP-CAP clinical trial showed that both drugs reduced the risk of mortality by 8.5 per cent when administered to patients within a day of entering intensive care alongside a corticosteroid, such as dexamethasone.
Professor Anthony Gordon, chair in anaesthesia and critical care at Imperial College London and a consultant in intensive care medicine at Imperial College Healthcare NHS Trust…
Hospital mortality was 27.3 per cent among patients receiving tocilizumab or sarilumab, compared with 35.8 per cent of patients in the control group who did not receive the drugs, the researchers said.
Treatment with tocilizumab or sarilumab is thought to cost somewhere between £750 and £1,000 and is administered intravenously either as a one or two dose regime.
Professor Gordon added: “For every 12 patients in intensive care you treat with these drugs, based on the evidence we saw, you would expect to save one life.” …
Tocilizumab and sarilumab have been added to the Government’s export restriction list, the Department of Health and Social Care (DHSC) said.
This will protect supply for UK patients by enforcing regulatory action on those who flout the restrictions, it added.
Commenting on the findings, Peter Horby, professor of Emerging Infectious Diseases, the University of Oxford’s Centre for Tropical Medicine and Global Health…
“Importantly, the findings of a benefit are in addition to corticosteroids, which were taken by 93 per cent of the participants.
“This means we now have two drugs, which combined have a greater effect.”

KEVZARA HELPS INHIBIT THE EFFECTS OF CHRONICALLY ELEVATED IL-6: KEVZARA targets and binds with high affinity to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), thereby inhibiting IL-6 signaling | @sanofi & @Regeneron
Sarilumab-Kevzara1 mechanism

UK approves anti-inflammatory drugs to treat sickest covid-19 patients after strong results in clinical trial (01/08/2021) | @washingtonpost,@Carolynyjohnson,@bbguari
…Jonathan Parr…
David E. Leaf, a Harvard Medical School assistant professor and Brigham and Women’s Hospital physician, said the data were game-changing: “For ICU patients, I think it is a slam dunk that they should be given tocilizumab if it can be given early on.”…
“We’re currently live in 290 sites around the world, and so there was no way to quietly whisper to 290 sites: ‘Stop randomizing to control in the immune modulation arm, but don’t tell anyone,’ ” said Derek Angus, chair of critical care medicine at the University of Pittsburgh Medical Center and one of the investigators of the trial. …
The list price of the dose of Kevzara used in the trial is about $3,600. The maximum dose used in the trial of Actemra currently carries a list price of $4,600, but the dose varied by patients’ body weight and could be given either once or twice. Bob Purcell, a spokesman for Genentech, a member of the Roche Group, said that the drug was not approved for use in covid-19 and the pricing might differ if it were approved to treat the illness. …
About 36 percent of patients died in the hospital who received standard care, while 28 percent died on tocilizumab and 22 percent died when given sarilumab. Patients treated with the drugs spent about a week less in the ICU, on average. …

UK Approves Arthritis Drugs for Critically Ill COVID-19 Patients (01/11/2021) | @TheScientistLLC,@AsherGJones
… The study, which has not yet been peer-reviewed, evaluated around 800 patients in intensive care with severe COVID-19. Around half received the standard of care while 353 received tocilizumab and 48 received sarilumab. The researchers found that 35.8 percent of those given standard care died, compared with 28 percent who received tocilizumab and 22.2 percent who were given sarilumab. …
The immunosuppressive drugs tocilizumab and sarilumab, which are primarily used to treat arthritis, block signaling of the cytokine IL-6, a key regulator of immune dysregulation and inflammation in severe COVID-19 cases. …
…Krutika Kuppalli, an infectious disease physician at the Medical University of South Carolina… @nytimes
…Jonathan Parr, an infectious diseases physician at the University of North Carolina at Chapel Hill… @washingtonpost

Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis (04/03/2021) | National Center for Biotechnology Information, U.S. National Library of Medicine
Sarilumab-Kevzara4 NIH-RA-developmentSarilumab-Kevzara3 NIH-RApatients-strategySarilumab-Kevzara5 NIH-SideEffects

Kevzara (Sarilumab injection, for subcutaneous use): side effects (05/18/2018) | @RxList
Kevzara (sarilumab) injection is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Common side effects of Kevzara include:
・low white blood cell count (neutropenia),
・increased ALT,
・injection site redness,
・upper respiratory infections,
・nasal congestion,
・runny nose,
・sore throat,
・urinary tract infections, and
・low platelet counts (thrombocytopenia). …

Sarilumab (Kevzara®) Drug Information Sheet | @jhrheumatology
Sarilumab-Kevzara2 JH-SideEffects

Kevzara Side Effects (09/13/2020) | @Drugscom
Side effects requiring immediate medical attention
… Check with your doctor immediately if any of the following side effects occur while taking sarilumab:
More common
・Bloody, black, or tarry stools
・chills
・cough
・fever
・lower back or side pain
・painful or difficult urination
・pale skin
・sore throat
・ulcers, sores, or white spots in the mouth
・unusual bleeding or bruising
・unusual tiredness or weakness
Less common
・bladder pain
・bloody or cloudy urine
・body ache or pain
・difficulty breathing
・ear congestion
・frequent urge to urinate
・headache
・loss of voice
・nasal congestion
・painful cold sores or blisters on the lips
・runny nose
・sneezing
Rare
・difficulty swallowing
・dizziness
・fast heartbeat
・heartburn
・hives, itching, skin rash
・indigestion
・nausea
・puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
・severe stomach pain, cramping, or burning
・tightness in the chest
・vomiting of material that looks like coffee grounds, severe and continuing
Side effects not requiring immediate medical attention
More common
・bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For Healthcare Professionals
Dermatologic; Hematologic; Hypersensitivity; Immunologic; Local; Metabolic; Genitourinary; Hepatic; Respiratory; General; Gastrointestinal

Kevzara (Sarilumab), a New IL-6 Receptor Antagonist, Approved for Active Rheumatoid Arthritis (03/2018) | American Health & Drug Benefits @TheLynxGroup
Mechanism of Action
Sarilumab is a human recombinant monoclonal antibody that binds to IL-6 receptors that inhibit IL-6?mediated signaling. The IL-6 cytokine plays a role in the body’s inflammatory process and response. The production of IL-6 by synovial and endothelial cells can lead to local production of IL-6 in the joints affected by RA and other inflammatory processes. Elevated levels of IL-6 have been correlated with disease activity and joint damage in patients with RA.
Dosing and Administration
The recommended dosage of sarilu-mab is 200 mg once every 2 weeks, administered as a subcutaneous injection; it is available as a 150-mg/1.14-mL or 200-mg/1.14-mL solution in a single-dose, prefilled syringe, and can be used as monotherapy or in combination with methotrexate or other conventional DMARDs. …
Adverse Reactions
The most common (incidence ≧3%) adverse reactions associated with saril-umab therapy are neutropenia (7%), increased alanine aminotransferase levels (5%), injection-site erythema (5%), upper respiratory infections (4%), and urinary tract infections (3%).
Drug Interactions
Cytokines and cytokine modulators can influence the activity of specific cytochrome (CY) P450 enzymes (including CYP3A4) and thus may alter the metabolism of drugs that are substrates of these enzymes. Use caution when sarilumab is co-administered with CYP3A4 substrate drugs for which decreased effectiveness is undesirable (eg, oral contraceptives, statins).
Use in Specific Populations
Nursing women may need to discontinue sarilumab or discontinue nursing.
No differences in safety or efficacy of sarilumab were seen between older (aged ≧65 years) and younger patients.
Warnings and Precautions
The prescribing information for saril-umab includes a boxed warning stating that sarilumab is associated with an increased risk for serious and potentially fatal infections, including bacterial, viral, invasive fungal, and other opportunistic infections. Patients should be monitored closely for infection while receiving sarilumab.
Sarilumab has been associated with reduced ANC, including neutropenia; a reduction in platelet counts; transaminase elevations; and lipid abnormalities.
The risk for gastrointestinal perforation may be increased when sarilumab is used concomitantly with NSAIDs or with corticosteroids.
Treatment with immunosuppressant drugs, including sarilumab, may increase the risk for malignancies.
Sarilumab should be discontinued immediately if anaphylaxis or a hypersensitivity reaction occurs.
Sarilumab should not be used with live vaccines.
* Kevzara (sarilumab) injection [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals; Bridgewater, NJ: sanofi-aventis U.S.; May 2017.

Repurposed Drugs to Fight SARS-CoV-2, Tocilizumab and Sarilumab – Part 4 (04/15/2021) | @_Monocl
Tocilizumab and sarilumab reduce COVID-19 patient mortality by 8.5 percent, data shows (07/01/2021) | @PharmaReview
Kevzara (sarilumab) | @mnt
Sarilumab (Subcutaneous Route) | @MayoClinic
Efficacy and safety of sarilumab in patients with active rheumatoid arthritis (01/11/2018) | National Center for Biotechnology Information, U.S. National Library of Medicine
Sarilumab | @sciencedirect

World 世界情勢等 Vol.8

All the below links are in English.

取り急ぎ以下(内容事項一部抜粋ご参考まで)貼っておきます。

World Vol.59 cities,history StockMarket,volatility GlobalWealthReport BlackRock WasteManagement NZ Russia VaccineRollout,UK ND,SD,NE,KS,FL

World Vol.58 (U.S., Australia, etc.) BlackFriday grocers FedEx,DHL,UPS SickLeave Perth Taiwan China salmon TN,KY,NM,WY

World Vol.57 (Joe Biden, Janet Yellen, etc.) China HumanRights Europe Russia travel FinancialStability Lego,Colosseum MilkyWay Scotland county-by-county OR,AK,HI,NY,MA,MI

World Vol.56 (U.S., etc.) FederalReserveBanks Pfizer BioNTech Moderna top20counties MI,ME,MA,MT,MO,TX,WV,WY,CO,NE,ND,IA Canada UK(NI)

World Vol.55 (incl 2019) masks sanctuary Ecuador,chocolate NZ RCEP MD,NM,AZ,VA

World Vol.54 (Eastern Europe, U.S.) coronavirus GiantShoppingMall EuropeanCapitalOfCulture Montenegro esports OH,TN,UT,NM,ID,CO,IN,KY,TX,FL Quebec,Inuit

World Vol.53 (U.S., etc.)
この日付は11/3となっていますが、少々気を遣うあまり投稿しないまま忘れてしまっており、つい先程投稿しましたので、実質的日付は 12/9 です。
OnlineChess bookstores beaches Walmart bettors election FL,NC,SC,IN,OH

World Vol.52 (U.S.) food AbsenteeBallot MaskRequirements antitrust,monopoly AmyConeyBarrett AL,AR,TN,TX,NYC

Caucasus Vol.2 (2020 Nagorno-Karabakh War)

なお、先程発見した客観的事実として、弊社英語ウェブサイトの検索欄に「World Vol.」と入れると(そのURLは http://worldsolutions.work/?s=World+Vol. です)、
「 This page isn’t working  worldsolutions.work is currently unable to handle this request. HTTP ERROR 500 」
と出て来るようになってしまっています。
最近「World Vol.」シリーズでアメリカ国内の地方テレビ局のツイートを(あくまで一般感覚的に普通に)少々貼っておりましたが、それを検索されるのを好まない人達が居るということかと推察いたします。

Science and Technology 科学技術 Vol.18 / #Coronavirus #コロナウイルス Vol.21

All the below links are in English.

取り急ぎ以下(黒字部分は内容事項一部抜粋ご参考まで)貼っておきます。

Science and Technology Vol.49 COVID19 vaccines materials AI,robotics
Science and Technology Vol.48 (incl 2019) telehealth coronavirus pandemics MachineLearning triage ventilator nurses startup chemicals GPS HorizonEU electrification
Science and Technology Vol.47 (incl 2019) digitalhealth PhysicalDistancing immunotherapy food molecular metal
Science and Technology Vol.46 (personal protective equipment (PPE) suppliers/manufacturers) 
Science and Technology Vol.45 telemedicine COVID19vaccine ventilators vitaminD kidneyinjury,AKI periosteum
Science and Technology Vol.44 GeorgeRutherford,UCSF MichaelOsterholm,UMN ArtificialIntelligence BreathTestingSystem,Shimadzu,TohokuUniversity
Science and Technology Vol.43 NobelPrizes/Physiology&Medicine/Physics/Chemistry
Science and Technology Vol.42 (miscellaneous) IgNobelPrizes heart-healthy lutein dexamethasone(Trump)
Science and Technology Vol.41 (miscellaneous) 3Dimaging/3Dprinting underwaterRobot water foodwaste nutrition planet
Science and Technology Vol.40 symptoms LosAngeles colleges,universities BigData,DataScience 3Dprinting,PPE ClimateChange Antarctica BraineatingAmoeba

#Coronavirus #コロナウイルス Vol.20(vaccines ワクチン) / U.S.A. アメリカ Vol.130(Massachusetts マサチューセッツ州 Vol.4 / New York ニューヨーク州 Vol.5: pharmaceutical corporations 製薬会社 – Moderna モデルナ社、Pfizer ファイザー社)

All the below links, excerpts, and tweets are in English.

cf. #Coronavirus #コロナウイルス Vol.19(vaccines ワクチン) / U.S.A. アメリカ Vol.129(New York ニューヨーク州 Vol.4 / Massachusetts マサチューセッツ州 Vol.3: pharmaceutical corporations 製薬会社 – Pfizer ファイザー社、Moderna モデルナ社)

昨日に引き続き取り急ぎ以下貼っておきます。

Multidose COVID-19 vaccines will test state tracking systems: People have to get two shots of the same type of vaccine (12/04/2020) | @verge
… Both take two doses, given a few weeks apart, and both could be circulating at the same time. And that’s just the two front-runners. Other multidose vaccines are still in the development pipeline.
There are a few ways states, doctors, and patients could keep the dosages straight, says Claire Hannan, executive director of the Association of Immunization Managers. In the simplest solution, everyone who gets a COVID-19 vaccine will also get a card that tells them which vaccine they had and when their next dose should be. But that’s the last line of defense in a complex vaccine tracking system. “As the backup to the backup to the backup, they’ll hand out cards,” Hannan says.
Ideally, the cards won’t be necessary because patients and doctors will be able to rely on electronic records and digital registry systems to keep track of who got which vaccine and when they got it. Through the pandemic, states have struggled with digital systems for other key areas, like COVID-19 testing – sometimes relying on fax machines and incomplete, handwritten forms to send information from testing sites to local health departments. But Hannan says the US immunization data collection systems at the state level are prepared to manage the expected crush of information from an unprecedented mass vaccination campaign like the one the country is about to start. Most tools were in place even before the pandemic hit. …
Big health systems with robust electronic health record management will likely have an easier time with this process than smaller clinics, says Howard Forman, a professor of public health, management, and economics at Yale University. “They’re used to keeping track of whether patients have had their followup appointments…
… Each state has its own Immunization Information System (IIS), a centralized registry that keeps track of every vaccine each person vaccinated in that state has received. Vaccination clinic software and electronic health records systems feed into those registries, which help doctors keep track of the vaccination records for individual patients, and also give each state big-picture data on vaccination rates in individual communities.
A state-level IIS can also notify doctors and patients when people are due for a second dose of a vaccine. They already use them to keep track of doses for the meningitis B vaccine…
The systems in place to track vaccinations today are much more advanced than they were in 2009, when the country struggled to distribute and track the H1N1 flu vaccine (which was only one shot), and electronic health records were rare. Only some states used their IIS programs. Many states had to rely on SurveyMonkey to connect with health care providers about vaccine delivery…

Moderna reaffirms 20M vaccine dose goal for December (12/04/2020) | @BosBizJournal
… The biotech has enlisted Italian firm Lonza to ramp up production to 500 million to one billion doses of the vaccine annually and Catalent Inc. to make all of the labels, seals and glass vials. Local life sciences unicorn Ginkgo Bioworks has also been helping Moderna optimize its production of raw materials for the drug.
Moderna has additionally hired another 150 employees to produce the vaccine out of its Norwood manufacturing facility. …

Moderna says its vaccine candidate has ‘potential’ to confer longer-term immunity (12/03/2020) | @MarketWatch
…National Institute of Allergy and Infectious Diseases…
The company said it remained confident it will have 20 million doses of the vaccine candidate available in the U.S. by the end of the year, and it expects to have between 100 million and 125 million doses available globally in the first quarter of next year.
Of these, between 85 million and 100 million will be available in the U.S. and between 15 million and 25 million will be available elsewhere…

Moderna’s 3-month data raise hopes for COVID-19 vaccine durability (12/04/2020) | @FierceBiotech
… Moderna shared details of the NEJM letter alongside an update on its effort to scale up production. …
Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate (12/03/2020) | @moderna_tx
… “mRNA-1273 produced high levels of binding and neutralizing antibodies that declined slightly over time, as expected, but they remained elevated in all participants three months after the booster vaccination.”…
Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination (12/03/2020) | @NEJM

What it feels like to get Moderna’s COVID-19 vaccine: “It’s not pleasant, but it’s definitely worth the risk of developing these side effects to make sure we can find an end to this pandemic.” (12/03/2020) | @BostonDotCom
Saginaw doctor who took part in Moderna vaccine trial seeks to reassure public (12/04/2020) | @MLive
Moderna Says COVID Vaccine Could Create Immunity For At Least Three Months (w Video; 12/04/2020) | @wbz
New data shows people who got Moderna vaccine still had antibodies 3 months later: The data came from a small number of phase 1 participants. (04/12/2020) | @ABCNews
Continuing COVID-19 vaccine trials may put some volunteers at unnecessary risk. Is that ethical? (w Video; 12/04/2020) | @USATODAY
No legal grounds for employers to force employees to get vaccinated, say experts (12/04/2020) | @CTVNews

Canada doubles Moderna vaccine order, daily COVID-19 cases could top 10,000 by January (12/04/2020) | @reuters
… Anand also said FedEx Corp and Innomar Strategies, a Canada-based division of AmerisourceBergen, had been contracted by the federal government to provide logistical support on vaccine delivery.

Moderna COVID vaccine best for Nunavut because of storage, shipping: top doctor (12/04/2020) | @CKOMNews
… Moderna’s vaccine is preferred because the Pfizer one requires cold storage and shipping would be too difficult in Nunavut. …

Two vaccines might get emergency approval this month. Here’s what you need to know (12/01/2020) | @latimes
What about those second doses?
The CDC’s vaccine tracking system will monitor who gets a first dose and will coordinate with Pfizer and Moderna on the shipment of the second doses. This means medical centers can administer all the doses they initially receive without having to hold onto half for the second shot.
How long before I can drive to my local pharmacy and get a vaccine?
If you’re healthy and a nonessential worker, you will have to wait. Most experts feel that the immunization effort in the United States will be in high gear by late spring and early summer of 2021…

Moderna to submit Covid-19 vaccine to FDA as full results show 94% efficacy (11/30/2020) | @statnews
… Moderna said that safety data is being reviewed continuously, but that there are no new serious safety concerns. The most common adverse events included site pain, fatigue, muscle or bone pain, headaches, and redness at the injection site. The reactions were more serious in the vaccine group after patients received a second dose. The results Pfizer and BioNTech released 12 days ago for their vaccine are roughly similar. …
… Each strand of synthetic mRNA is designed to encode for a protein found on the surface of SARS-CoV-2, the virus that causes Covid-19. Those mRNA strands enter the body’s cells and instruct them to produce that protein. The immune system then recognizes it as a foreign invader and produces antibodies that protect against Covid-19 if a person is later exposed to the virus.
The Covid-19 vaccine would be Moderna’s first product approved by the FDA and, assuming Pfizer’s vaccine is approved first, only the second mRNA medicine ever licensed. …

Moderna’s COVID-19 Vaccine Candidate Gets More Good News (w Voice; 11/30/2020) | @NPR
… Both use the same novel technology. Instead of injecting a weakened or dead virus, which is a common strategy for vaccines, these products are essentially small pieces of genetic material. When that’s injected into a person’s arm, it’s picked up by cells in the immune system. The cells read the genetic code and use that to produce a protein that is actually a key fragment of the coronavirus. The body then builds antibodies that latch onto that fragment, so if and when someone encounters the actual coronavirus, the body is primed to fight it off with antibodies. …

#Coronavirus #コロナウイルス Vol.19(vaccines ワクチン) / U.S.A. アメリカ Vol.129(New York ニューヨーク州 Vol.4 / Massachusetts マサチューセッツ州 Vol.3: pharmaceutical corporations 製薬会社 – Pfizer ファイザー社、Moderna モデルナ社)

All the below links, excerpts, and tweets are in English.
cf.
U.S.A. アメリカ Vol.107(New York ニューヨーク州 Vol.2: pharmaceutical corporations 製薬会社)
U.S.A. アメリカ Vol.113(Massachusetts マサチューセッツ州 Vol.2: pharmaceutical corporations 製薬会社)

取り急ぎ以下貼っておきます。

Pfizer And Moderna Face Their Biggest Challenge: Vaccinating The World (12/03/2020) | @IBDinvestors
… The obstacles can’t be overestimated, experts say. The vaccine supply chain is mindbogglingly complex. It involves local, state and federal authorities as well as hospitals, pharmacies and doctors’ offices.
The two most advanced coronavirus vaccines must be stored at specific temperatures and given in two doses several weeks apart. Stakeholders must keep tabs on who gets which vaccine and when. And don’t forget the public perception challenges of vaccinating people with drugs that went through clinical testing at record speeds.
Experts say 60% to 80% of the world must be vaccinated to achieve herd immunity. It will be many months – or years – before that happens as vaccine makers iron out supply constraints. Besides the Covid-19 vaccine companies themselves, a raft of other parties like drug distribution company McKesson (MCK) will be involved.
…the Centers for Disease Control and Prevention. The agency has overseen vaccine distribution in the U.S. for decades, including the national effort to vaccinate during the H1N1 influenza pandemic in 2009.
The coronavirus vaccination effort will probably look similar to that…
First, vaccination sites will need to enroll in the CDC’s Covid-19 vaccine distribution program. These sites will include doctors’ offices, clinics, hospitals and pharmacies. The program ensures these locations have enough well-trained staff, the right equipment and space to vaccinate large numbers of people.
Then, the vaccination sites will request doses of the coronavirus vaccine through a state agency…
Public health officials will then confirm the vaccination site is approved. If so, the order will head to the CDC. …
In August, the CDC tapped McKesson to help it distribute all coronavirus vaccines. …McKesson could rely on UPS, DHL and FedEx trucks to help it get the job done.
Pfizer, on the other hand, has a bigger challenge. The company’s coronavirus vaccine must be stored at ultracold temperatures. How cold? Penguins would find these temperatures chilly. …
Moderna’s vaccine can live in a standard refrigerator for 30 days. It can also be frozen for six months. Once thawed, providers must administer the vaccine within 12 hours – or toss it out. That creates a logistical challenge for transportation.
“Moderna will be heavily reliant on external suppliers…It will be using companies like CryoPort (CYRX), Stirling Ultracold and CH Robinson (CHRW) to work out cold chain logistics plus storage and shipping management.” …
…Pfizer has developed a special shipping container that can store the coronavirus vaccine for 10 days unopened…
The vaccine can be stored in an ultracold freezer for up to six months. It can stay in the shipping container for up to 30 days when replenished with dry ice every five days. Or, the drug can be stored for five days in a standard refrigerator.
…the strict storage requirements limit where Pfizer’s vaccine can be used. Those ultracold freezers cost about $20,000 apiece. …
…”Imagine getting one dose to Appalachia, a rural community. Now imagine having to come back and making sure everyone who got the first dose also gets the second one. That’s a challenge.”
…it’s likely the Pfizer vaccine will go to more populous locations with cold-storage capabilities. Coronavirus vaccine stock Moderna will probably send its drug to more rural communities.
…expects Pfizer to generate $875 million in coronavirus vaccine sales in 2020 and $7.25 billion in 2021. Eventually, that will trend down to $700 million to $800 million each year, depending on how often people need booster shots of the vaccine. …
“The drugmaker that gets this thing out first…Overnight, Pfizer becomes one of the most loved brands in America. It’s the McDonald’s (MCD) of the pharma industry.”
COVID19 vaccine-efforts

Pfizer to Ship Half as Many Coronavirus Vaccine Doses as Originally Planned in Initial Phase (12/03/2020) | @themotleyfool
…”Scaling up the raw material supply chain took longer than expected, and it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”
BNT162b2, which showed an extremely high efficacy rate of 95% with no serious safety concerns in phase 3 clinical trials, has been submitted for similar approvals throughout the European Union, and with the U.S. Food and Drug Administration (FDA). In the wake of the U.K. approval, Pfizer and BioNTech anticipate decisions from other major regulators this month. …

Pfizer Scaled Back Vaccine Output Targets Earlier This Year (12/03/2020) | @business
…supply-chain problems caused the New York-based drugmaker to reduce the number of vaccines…led Pfizer shares to fall as much as 3.1% and caused the wider stock market to dip. The S&P 500 ended Thursday’s trading down 0.1%. …
Moderna Inc., which has also submitted a messenger RNA-based vaccine to the FDA for emergency clearance, said in a statement on Thursday it would have between 100 million and 125 million doses available globally in the first quarter of 2021. …

UK becomes the first to approve Pfizer-BioNTech Covid vaccine, rollout due next week (12/02/2020) | @CNBC
…with elderly people in care homes and medical workers first in line. …
“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA)…
Pfizer and BioNTech announced in July an agreement with the U.K. to supply 30 million doses of its mRNA-based vaccine…increased to 40 million doses in early October. As a two-dose vaccine, the U.K. will have enough doses to vaccinate around a third of its 66 million population. …
“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way. A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Peter Liese, a member of German Chancellor Angela Merkel’s party…

Pfizer supply chain challenges led to slashing COVID-19 vaccine production target – WSJ (12/03/2020) | @reuters,@YahooFinance
…anticipates producing 50 million doses of its COVID-19 vaccine this year. That is down from an earlier target of 100 million doses. Pfizer’s vaccine relies on a two dose regimen, meaning 50 million doses is enough to inoculate 25 million people. …
David Perdue bought Pfizer stock – a week before company said it would develop a vaccine (12/03/2020) | @salon

Science and Technology 科学技術 Vol.17 / #Coronavirus #コロナウイルス Vol.18(masks マスク)

All the links and excerpts are in English.

Cloth masks do protect the wearer – breathing in less coronavirus means you get less sick (08/19/2020) | @ConversationEDU
Exposure dose determines severity of disease
Masks reduce viral dose
Masks increase rate of asymptomatic cases
…in places where everyone wears masks, the rate of asymptomatic infection seems to be much higher. …

Effectiveness of Cloth Masks for Protection Against Severe Acute Respiratory Syndrome Coronavirus 2 (10/2020) | @CDCgov
Factors to Consider when Using Cloth Masks to Protect Wearers and to Prevent Spread of Infection during the COVID-19 Pandemic
…droplets travel >2 m, in some instances ≒8 m… …SARS-CoV-2 may be transmitted up to 4 m…
…multilayered masks with water-resistant fabric, high number of threads, and finer weave may be more protective… Masks should be able to prevent a stream of fluid flowing at a pressure of up to 160 mm Hg from seeping through the mask and potentially into the mouth. …
Cloth masks…ideally washing in hot water with soap. Other methods or products include using bleach, isopropyl alcohol, or hydrogen peroxide; autoclaving or microwaving; and application of ultraviolet radiation or dry heat…
…in a widespread pandemic, differentiating asymptomatic from healthy persons in the community is very difficult, so at least in high-transmission areas, universal face mask use may be beneficial. The general public should be educated about mask use because cloth masks may give users a false sense of protection because of their limited protection against acquiring infection…
ClothMasks_table

Surgical Masks, Respirators, Face Shields: Which Masks Actually Protect Against Coronavirus? (02/28/2020) | @MedicalExpoEmag
… The particles of the SARS-CoV-2 virus are extremely small – 0.12 micrometers, 0.12 thousandths of a millimeter – and can last several tens of minutes in the air when they are expelled by someone contaminated who is coughing, talking or even breathing. …
1. Surgical Masks
In Europe…
Type I: bacterial filtering effectiveness > 95%
Type II: bacterial filtering effectiveness > 98%
Type IIR: 98% and splash-resistant
2. Respirators
FFP2: 3M, Honeywell…
3. “Barrier” Masks
4. Face Shields

Coronavirus (COVID-19) – Face masks: How they protect you and when to use them (11/11/2020) | Australian Government Department of Health
Australia DepartmentOfHealth

Some masks offer far less coronavirus protection than others. Bandanas, scarves, and shields do an especially bad job. (11/28/2020) | @businessinsider
One chart shows the best and worst face masks for coronavirus protection – and which situations they’re suited for (11/26/2020) | @businessinsider
FaceCoverings

Coronavirus disease (COVID-19) advice for the public: When and how to use masks (20/10/2020) | @WHO
The three-layer fabric mask (YouTube)
How to wear a fabric mask (YouTube)

What kind of face mask best protects against coronavirus? (18/08/2020) | @guardian
Why a face shield alone may not protect you from coronavirus (w Radio; 07/08/2020) | @BBC_Future
Coronavirus: What are the rules for face masks or face coverings? (30/10/2020) | @BBC

Can Face Masks Protect You from the 2019 Coronavirus? What Types, When and How to Use | @Healthline
Wear Masks To Protect Yourself From The Coronavirus, Not Only Others, CDC Stresses (11/11/2020) | @NPR
What type of mask works best for COVID-19 protection? (08/14/2020) | @MDAndersonNews
Coronavirus Face Masks & Protection FAQs | @HopkinsMedicine
COVID-19: How much protection do face masks offer?: Get answers to your questions about face masks, including how to use them properly. | @MayoClinic

Science and Technology 科学技術 Vol.16 / #Coronavirus #コロナウイルス Vol.17(sequelae 後遺症)

All the links and excerpts are in English.

JFYI   あくまでご参考です。

Late Sequelae of COVID-19 (11/13/2020) | @CDCgov
Characterization of the etiology and pathophysiology of late sequelae is underway, and may reflect organ damage from the acute infection phase, manifestations of a persistent hyperinflammatory state, ongoing viral activity associated with a host viral reservoir, or an inadequate antibody response. Factors in addition to acute disease that may further complicate the picture include physical deconditioning at baseline or after a long disease course, pre-COVID-19 comorbidities, and psychological sequelae following a long or difficult disease course as well as those relating to lifestyle changes due to the pandemic. Likely, the persistent sequelae of COVID-19 represent multiple syndromes resulting from distinct pathophysiological processes along the spectrum of disease.
Though there is limited information on late sequelae of COVID-19, reports of persistent symptoms in persons who recovered from acute COVID-19 illness have emerged. The most commonly reported symptoms include fatigue, dyspnea, cough, arthralgia, and chest pain. Other reported symptoms include cognitive impairment, depression, myalgia, headache, fever, and palpitations. More serious complications appear to be less common but have been reported. These complications include:
・Cardiovascular: myocardial inflammation, ventricular dysfunction
・Respiratory: pulmonary function abnormalities
・Renal: acute kidney injury
・Dermatologic: rash, alopecia
・Neurological: olfactory and gustatory dysfunction, sleep dysregulation, altered cognition, memory impairment
・Psychiatric: depression, anxiety, changes in mood

Long-term Health Consequences of COVID-19 (w PDF; 10/05/2020) | @JAMA_current
Manifestations
The most commonly reported symptoms after acute COVID-19 are fatigue and dyspnea. Other common symptoms include joint pain and chest pain. In addition to these general symptoms, specific organ dysfunction has been reported, involving primarily the heart, lungs, and brain. From a pathogenesis standpoint, these complications could be the consequence of direct tissue invasion by the virus (possibly mediated by the presence of angiotensin-converting enzyme 2 receptor), profound inflammation and cytokine storm, related immune system damage, the hypercoagulable state described in association with severe COVID-19, or a combination of these factors.
Cardiovascular
Myocardial injury, as defined by an increased troponin level, has been described in patients with severe acute COVID-19, along with thromboembolic disease. Myocardial inflammation and myocarditis, as well as cardiac arrhythmias, have been described after SARS-CoV-2 infection. … However, an increased incidence of heart failure as a major sequela of COVID-19 is of concern, with considerable potential implications for the general population of older adults with multimorbidity, as well as for younger previously healthy patients, including athletes.
Pulmonary
…interstitial thickening and evidence of fibrosis. …decreased diffusion capacity for carbon monoxide and diminished respiratory muscle strength…
Neurologic
…headache, vertigo, and chemosensory dysfunction (eg, anosmia and ageusia). …encephalitis, seizures, and other conditions such as major mood swings and “brain fog”…

What we know about sequelae and lingering COVID-19 symptoms (09/16/2020) | @SingleCare
What are coronavirus sequelae?
…brain fog, fatigue, difficulty concentrating…
Who will experience coronavirus sequelae?
…“Sequelae of the disease have been seen in people with mild cases of COVID-19.”
In other words, it’s not yet proven who is affected by sequelae.
What are the symptoms of coronavirus sequelae?
Fever; Fatigue; Muscle or body aches; Joint pain; Shortness of breath; Difficulty concentrating (or “brain fog”); Nausea, heartburn, or vomiting; Headache; Difficulty sleeping; Prolonged loss of taste or smell; Hair loss …
… “There are some individuals who may have long-lasting kidney damage, blood clots, or other problems of the blood vessels and skin as well as worsening hypertension (high blood pressure).”
…lasting effects on the heart. …cardiac involvement…myocardial inflammation…lasting damage to the lungs, including post-COVID fibrosis.
What causes coronavirus sequelae?
…the SARS-COV-2 utilizes the spiky protein on its membrane to interact and bind to the ACE 2 receptors, which can be seen in the lungs, heart, and various organs to trigger an inflammatory response…
…inflammation of the heart muscle…heart palpitations, fast heart rate (tachycardia), irregular heartbeat or chest pressure…
… Part of the cascade of events includes the release of cytokines, in the blood, which mediate subsequent immune responses against the foreign invader (the virus). In the event where such mediators cross the blood brain barrier and accumulate in the central nervous system, they can activate the primitive regulatory parts of the brain phenomenon, resulting in many of the symptoms seen in post-viral syndrome. This was also observed in select patients who contracted SARS during the 2002-2003 outbreak.”
What should you do if you experience coronavirus sequelae?
Taking over-the-counter pain relievers such as Tylenol or ibuprofen; Eating a balanced and healthy diet; Getting plenty of sleep and resting during the day as needed; Practicing relaxation techniques such as yoga, massage therapy, and meditation

Coronavirus disease 2019 (COVID-19): Clinical features (11/20/2020) | @UpToDate
Recovery and long-term sequelae
… The most common persistent symptoms were fatigue (53 percent), dyspnea (43 percent), joint pain (27 percent), and chest pain (22 percent)…
… Although a lack of return to baseline health was associated with older age and a greater number of underlying comorbidities, approximately one in five individuals aged 18 to 34 years who were previously healthy reported that they did not return to baseline within two to three weeks.

Will the COVID-19 pandemic result in significant neuropsychiatric sequelae? | @Immunopaedia
Epidemiological Alert: Complications and sequelae of COVID-19 (w PDF; 12/08/2020) | @pahowho
Epidemiological Alert: Complications and sequelae of COVID-19 (w PDF; 12/08/2020) | @reliefweb

Science and Technology 科学技術 Vol.15 / #Coronavirus #コロナウイルス Vol.16(pharmaceutical products 医薬品 Vol.7:drugs 治療薬)

All the below links and excerpts are in English.

coronavirus及びdrugsと入れてグーグル検索して出て来たリンクと当方作成の抜粋を取り急ぎ以下のとおり貼っておきます。
cf. Science and Technology 科学技術 Vol.11 / #Coronavirus #コロナウイルス Vol.13(pharmaceutical products 医薬品 Vol.4:drugs 治療薬)

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 (11/19/2020) | FDA
…an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
… Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19. …
Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Baricitinib is a prescription oral tablet medication that is FDA-approved (and sold under the brand name Olumiant) for the treatment of moderately to severely active rheumatoid arthritis. …
Remdesivir is an FDA-approved (and sold under the brand name Veklury) intravenous antiviral drug for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Remdesivir also remains authorized for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (about 7.7 pounds) to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. …
… Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results and allergic reactions.
The EUA was issued to Eli Lilly and Company. …

Antiviral Drugs That Are Approved or Under Evaluation for the Treatment of COVID-19 (11/03/2020) | NIH
see Table 2
Remdesivir
Chloroquine or Hydroxychloroquine With or Without Azithromycin
Lopinavir/Ritonavir and Other HIV Protease Inhibitors
Ivermectin

The Latest Research on COVID-19 Treatments and Medications in the Pipeline (11/18/2020) | @GoodRx
… Remdesivir is also being studied in combination with other medications. Early results reported that hospitalized COVID-19 patients who got both remdesivir and baricitinib (Olumiant) recovered about 1 day faster than those who only got remdesivir. Additionally, patients had a 30% higher chance of clinical improvement at day 15 when taking both medications together. The full data has not been shared yet.
Not all remdesivir studies have been promising. On October 15, 2020, a large, randomized study from the World Health Organization (WHO) found that remdesivir had little or no effect on death rate in hospitalized patients with COVID-19. The death rate was about 11% regardless of whether patients got remdesivir or not. These results have not been peer-reviewed yet. …

WHO suspends remdesivir from list of medicines (20/11/2020) | @RTE
… “The … panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” the guideline said. …
At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir, which is also known as Veklury.
The antiviral is one of only two medicines currently authorised to treat Covid-19 patients across the world…

Experimental drug given to Trump to treat covid-19 wins FDA clearance: But Regeneron’s antibody treatment is expected to be in short supply. (11/21/2020) | @washingtonpost
… The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body’s natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly & Co.’s drug on Nov. 9.
Regeneron’s drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective in treating mild to moderate covid-19 in adults and children 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized.
But as with the Lilly treatment, the Regeneron drug is a biological product that is complicated and time-consuming to make…
In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms of covid-19. …
Through Operation Warp Speed, the Trump administration effort to speed up treatments and vaccines, the government has bought 300,000 doses each from Lilly and Regeneron at a cost of about $1,250 and $1,500 per dose, respectively, with an option to buy hundreds of thousands more. But that comes as the nation is approaching 200,000 new coronavirus cases each day.
In a sign of how quickly the supply could be used up as the pandemic surges across the country, 40 percent of the doses of Lilly’s bamlanivimab has already been allocated to states. …

Rheumatoid arthritis drug appears to help Covid patients in ICU: Trial suggests that tocilizumab improves outcomes for critically ill patients, say researchers (19/11/2020) | @guardian
… Tocilizumab, a medicine that dampens down inflammation, improved outcomes for critically ill patients…
…if confirmed by more trial data, the drug will be on track to become only the second effective therapy for the sickest Covid patients, following positive results for the steroid dexamethasone earlier this year. …
Dexamethasone, which costs about £5 per dose, was found in trials to cut the risk of death by a third for patients on ventilators. It is now part of standard care for Covid patients in hospital.
Tocilizumab costs between £500 and £1000 depending on whether patients receive one or two doses. …
cf. Science and Technology 科学技術 Vol.14 / #Coronavirus #コロナウイルス Vol.15(pharmaceutical products 医薬品 Vol.6:drugs 治療薬)

SKI Complex Identified as Target for Antiviral Drugs to Combat Coronaviruses (11/20/2020) | @Contagion_Live
…the University of Maryland School of Medicine…
…a group of proteins which regulates certain aspects of normal functions within a cell. … also seems to be involved with the replication of infectious diseases such as influenza and coronaviruses. The complex aids with a virus’ ability to replicate its genetic material, or RNA, within the cell.
The complex was identified originally in yeast, and when present, degraded its viral RNA. …

Science and Technology 科学技術 Vol.14 / #Coronavirus #コロナウイルス Vol.15(pharmaceutical products 医薬品 Vol.6:drugs 治療薬)

All the below links and excerpts are in English.

Tocilizumab/Atlizumab(Actemra®)に係るリンクと当方作成の抜粋を取り急ぎ以下のとおり貼っておきます。

Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial (w PDF; 10/20/2020) | @JAMANetwork
PDF 
Tocilizumab1 JAMA1-1_keyTocilizumab2 JAMA1-2_effectTocilizumab3 JAMA1-3_effect

Efficacy and safety of tocilizumab in COVID-19 patients: A living systematic review and meta-analysis (w PDF; 11/05/2020) | @CMIJournal
Conclusion
Cumulative moderate certainty evidence shows that tocilizumab reduces the risk of mechanical ventilation in hospitalized COVID-19 patients. While RCTs showed that tocilizumab did not reduce short-term mortality, low certainty evidence from cohort studies suggests an association between tocilizumab and lower mortality. We did not observe a higher risk of infections or adverse events with tocilizumab use. This review will continuously evaluate the role of tocilizumab in COVID-19 treatment.

Efficacy of Tocilizumab on Patients With COVID-19 (08/24/2020) | @MGHMedicine,@genentech ClinicalTrials.gov @nlm_news
Brief Summary:
This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation.
The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection.
Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and all-cause mortality). We will also assess multiple pre-specified secondary (exploratory) endpoints and safety endpoints.
We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU, need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed with severe COVID-19 infection and evidence of exaggerated inflammatory response.

New results from a once-promising therapy show the difficulty of treating covid-19: In one study, the drug, tocilizumab, reduced risk of death in ICU patients, but two others found negligible results with slightly different patients (10/21/2020) | @washingtonpost
Studies offer little hope for tocilizumab in treating COVID (10/20/2020) | @CIDRAP
Time to Reassess Tocilizumab’s Role in COVID-19 Pneumonia (10/20/2020) | @JAMANetwork
Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19 (10/20/2020) | @JAMANetwork

Efficacy of Tocilizumab in Patients Hospitalized with Covid-19 (10/21/2020) | @NEJM
Tocilizumab for COVID-19? Three Studies Yield Mixed Findings (10/20/2020) | @JWatch
Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial (w PDF; 21/10/2020) | Journal of Translational Medicine
Appropriate use of tocilizumab in COVID-19 infection (w PDF; 10/2020) | International Journal of Infectious Diseases @ElsevierConnect
PDF 
Tocilizumab4 IJID_Turkey

Roche’s Actemra helps keep coronavirus patients off ventilators despite earlier trial flop (09/18/2020) | @FiercePharma
…Roche is also pairing Actemra with Gilead Sciences’ antiviral Veklury, better known as remdesivir, in the phase 3 Remdacta trial. Eli Lilly’s JAK arthritis med Olumiant combined with Veklury helped patients recover faster in a recent trial run by the National Institute of Allergy and Infectious Diseases.

Tocilizumab/IL-6 Inhibitors | @RealTimeCOVID19
Case report: use of lenzilumab and tocilizumab for the treatment of coronavirus disease 2019. | @WHO
Decreased Mortality in Coronavirus Disease 2019 Patients Treated With Tocilizumab: A Rapid Systematic Review and Meta-analysis of Observational Studies (w PDF; 23/09/2020) | @OUPAcademic
Tocilizumab for treatment patients with COVID-19: Recommended medication for novel disease (09/16/2020) | @NCBI
Efficacy of tocilizumab in COVID‐19: A systematic review and meta‐analysis (w PDF; 12/09/2020) | @WileyGlobal
Glucocorticoids, tocilizumab may reduce complications in COVID-19-related cytokine storm (09/03/2020) | @HealioRheum
Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study (w PDF; 08/14/2020) | @TheLancetRheum
Tocilizumab in patients with severe COVID-19: a retrospective cohort study (w PDF; 08/01/2020) | @TheLancetRheum
Chugai Starts Phase III Clinical Trial of Actemra for COVID-19 Pneumonia in Japan (04/08/2020) | @chugai_cc
What is the role of the IL-6 inhibitor tocilizumab (Actemra) in the treatment of coronavirus disease 2019 (COVID-19)? (11/10/2020) | @Medscape

Science and Technology 科学技術 Vol.13 / #Coronavirus #コロナウイルス Vol.14(pharmaceutical products 医薬品 Vol.5:drugs 治療薬)

All the below links and excerpts are in English.

Convalescent plasma(回復期血漿療法)に係るリンクと当方作成の抜粋を取り急ぎ以下のとおり貼っておきます。

The FDA has authorized convalescent plasma treatment for coronavirus patients – but some scientists worry it’s too soon (08/26/2020) | @businessinsider
During the 1918 Spanish flu pandemic, doctors discovered they could treat sick patients with the blood of those who had already recovered. …
Antibodies develop in plasma, the liquid portion of blood – they’re part of our body’s natural response to a foreign pathogen. So the idea behind the treatment is to help sick people mount an antibody response to the virus by transferring plasma intravenously from those who already have antibodies.
“What we really need are drugs that, when given early, can prevent a symptomatic person from requiring hospitalization or very dramatically diminish the time that they’re symptomatic,” …
… Plasma must be transferred quickly from a donor to a recipient – and both must have compatible blood types. The quantity is also limited, since it depends on blood donations. …
A national study of 35,000 hospitalized coronavirus patients, which is still awaiting peer review, found that patients less than 80 years old who weren’t on a respirator and received plasma containing high levels of antibodies within three days of their diagnosis had a 35% lower mortality rate than those who were treated four or more days after their diagnosis.
The process of creating hyperimmune globulin involves pooling plasma from recovered patients and heat-treating it so that any remaining pathogens get destroyed. The result is a vial of medicine with consistent antibody levels that can easily be administered to patients. The drug focuses on the most common antibody found in blood ? immunoglobulin G (IgG) – which usually confers long-term immunity.
… The Mount Sinai Hospital … working with Emergent BioSolutions, a Maryland-based biopharmaceutical company, to develop a hyperimmune globulin product. …
… “The Fight Is In Us” … The coalition hopes to secure regulatory approval from the FDA by the end of 2020. …

Why we don’t know if convalescent plasma works to treat Covid-19 (08/29/2020) | @qz
… “There’s no money to be made in plasma,” says Jeffrey Henderson, a physician and infectious disease researcher at Washington University St. Louis. Because it’s a biological product, it can’t be patented or sold for a profit. As a result, no single research group or company has funded a large, randomized controlled trial of plasma, the highest standard of clinical evidence. …
It isn’t cheap: Between 2012 and 2018, the median cost of bringing a drug to market was $985 million, about $19 million of which goes to clinical research. Typically, drug companies are happy to invest. Once their product is approved, they can sell it at a price that makes up for the loss (and then some). …
…expanded access program (EAP), a network spearheaded by researchers at the Mayo Clinic in Rochester, Minnesota…
… Eventually, the EAP program got some funding from the US Biomedical Advanced Research and Development Authority…
…Albert Einstein College of Medicine in New York…

Takeda, CSL-led alliance starts scaling up production of COVID-19 plasma therapy as phase 3 kicks off: report (10/13/2020) | @fiercepharma
… The clinical batches were produced at Takeda’s U.S. facility in Georgia and CSL’s site in Bern, Switzerland. The National Institute of Allergy and Infectious Diseases in the U.S. is running the trial. …
Eli Lilly and Regeneron have reported encouraging results for their antibody cocktails, each of which combines two synthetic monoclonal antibodies. While those products have less antibody variety, they only used donated plasma to help identify the antibodies with the most promise in fighting COVID. …

DOD Awards $750,000 to Plasma Technologies, LLC for Manufacturing of Convalescent Plasma Products Using a Novel Process in Support of the U.S. COVID-19 Response (08/17/2020) | DOD
… The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) partnered with HHS and the Army Contracting Command – Aberdeen Proving Ground (ACC-APG), to select Plasma Technologies, LLC for this cooperative agreement. Plasma Technologies, LLC, a plasma biologics technology company, is located in Charleston, South Carolina. …

Plasma Therapy Global Market Report 2020-30: Covid 19 Growth and Change (07/30/2020) | CISION
Major players in the plasma therapy market are Takeda Pharmaceutical Company Limited, Bio Products Laboratory Ltd., Arthrex, Inc., Biotest AG, China Biologic Products Holdings, Inc., DePuy Synthes Companies, CSL Limited, Grifols, S.A., Octapharma, and Terumo BCT, Inc. …
The global plasma therapy market is expected to grow from $187.67 million in 2019 to $246.95 million in 2020 at a compound annual growth rate (CAGR) of 31.6%. The growth is mainly attributed to the COVID-19 outbreak and the urgent need to treat a growing number of cases. …
… In March 2020, Takeda Pharmaceutical Company Limited has initiated a plasma-therapy, Anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG), which is termed as TAK-888 for treating COVID-19. The TAK-888 utilizes the plasma collected from convalescent donors who have been cured of COVID-19 and is administered to the patient suffering from COVID-19.

CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration (05/07/2020) | @TakedaPharma
… In addition to those announced at its inception – Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda – the Alliance welcomes new industry members ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin. …
In parallel, the Alliance has confirmed it will work with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is currently anticipated to start in the summer…
“Hyperimmune globulin therapy has the potential to be one of the earliest treatment options for COVID-19, and we look forward to working with NIAID and health authorities to bring this therapy to patients as early as possible,” …
… To amplify awareness, the Alliance has gained support from large organizations outside of the plasma industry. Examples of those offering resources to the Alliance include Microsoft and Uber Health. Microsoft is providing technology support, including the Alliance website and the Plasmabot for donor recruitment. The Plasmabot streamlines the process for a potential donor to quickly gain information about their nearest collection center from across the member network. In parallel, Uber Health has agreed to donate 25,000 round-trip rides to transport potentially eligible donors to and from plasma collection centers. …

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy (04/06/2020) | @TakedaPharma
Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring (ASX:CSL/USOTC:CSLLY) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin immediately with the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine…

Trump admin funds plasma company based in owner’s condo (02/11/2020) | @ABCNews
Plasma Technologies LLC, Pepcid, ApiJect Systems America, Novavax
ThermoGenesis and ImmuneCyte Joint Venture Developing Several Convalescent Plasma and Antibody Therapeutic Approaches Against COVID-19, Featured on FOX40 and Other Local News Outlets (04/24/2020) | @biospace
Takeda, Other Firms Test Covid-19 Convalescent-Plasma Treatment: NIH funds study of high antibody concentrations combined with the antiviral remdesivir (10/08/2020) | @WSJ