World 世界情勢等 Vol.10(Biden Administration バイデン米政権) / U.S.A. アメリカ Vol.131

All the below links and tweets are in English.


就任式 inauguration
World Vol.79 (U.S. Presidential Inauguration Day – Ireland, United Kingdom)
World Vol.80 (U.S. Presidential Inauguration Day – Canada)
World Vol.81 (U.S. Presidential Inauguration Day – New Zealand, Europe, etc.)
World Vol.82 (U.S. Presidential Inauguration Day – Australia)
World Vol.83 (U.S. Presidential Inauguration, Biden Administration, etc.)
政策課題 policy issues
World Vol.84 (Biden Administration, etc. – U.S. think tanks)
World Vol.85 (Biden Administration, etc. – U.S. think tanks)
World Vol.86 (Biden Administration, etc. – U.S. think tanks)
World Vol.87 (Biden Administration – U.S. think tanks, etc. @ universities)


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。
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
・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
・loss of voice
・nasal congestion
・painful cold sores or blisters on the lips
・runny nose
・difficulty swallowing
・fast heartbeat
・hives, itching, skin rash
・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.9

All the below links are in English.


World Vol.69 (economics/economy) HymanMinsky,MinskyMoment Ponzi InstabilityHypothesis HerbertStein DirkBezemer ModernMonetaryTheory,MMT PostKeynesian MarcLavoie JanHatzius TiagoMata JonathanSchlefer
World Vol.68 (economics/economy, etc.) MiltonFriedman MartinWolf StephenKinsella GennaroZezza UBI EricBeinhocker bloomberg
World Vol.67 (Modern Monetary Theory #MMT, etc.) HymanMinsky,MinskyMoment ScottSumner WilliamMitchell RandallWray MartinWatts WarrenMosler PaulMcCulley ScottFullwiler WynneGodley StephanieKelton
World Vol.66 ClimateAction EconomicMeltdown IanGoldin broadband,digitization WorldEconomy Gazprom Shopify,Cargojet Russia vaccine CountryMusic MostAnticipatedBooks BestFantasyBooks MustReadBooks fireworks BarronPublicAffairs-list
World Vol.65 (Coronavirus, etc.) Oxford-AstraZeneca vaccine,vaccines UK Beethoven EuropeanUnion megabanks China,WELT TradeAndCooperationAgreement ClothMasks,PPE OysterShells,PPE TN,CA
World Vol.64 (U.K., U.S., etc.) BorisJohnson UrsulaVonDerLeyen TonyBlair GavinNewsom relief CARESact CA,PA
World Vol.63 (U.S., etc.) cybersecurity ConfederateFlags UK Canada Cuomo Amazon BarackObama,FavotiteMusic OutlawOceanP OH,NY
World Vol.62 (U.S., Australia, Canada, France, Spain, Sweden, etc.) EmmanuelMacron KingOfSweden CanadianComics barley,China,WTO,LoseLose Palestinian NY,NC,VA,SC
World Vol.61 (U.S., etc.) BehavioralScience cybersecurity FreeWorld AI military FederalDebt ElectoralCollege UrbanRuralDivide China vaccine ImmigrationSystem HospitalMonopolies monolith RentersRights Floodlines-podcast
World Vol.60 (U.S., finance, etc.) ForeignPolicy FinancialPolicy,MonetaryPolicy Oracle LegalChallenge,SCOTUS AG Cuomo Olympia,WA 1949polio UW NorthernLights GA,TX,WI,MI

Cyber Security etc. サイバーセキュリティ等 Vol.6

All the below tweets are in English.


U.K. イギリス Vol.33(Scotland スコットランド)

U.K. イギリス Vol.32(Brexit, Coronavirus, etc. ブレグジット、コロナウイルス など)

All the below tweets/links are in English.

UK Vol.175 (Coronavirus, Brexit, 2019, etc.)
UK Vol.172
UK Vol.171
UK Vol.173 (pharmaceutical corporations: Seqirus) / Australia Vol.30
UK Vol.174 (quality & safety solutions corporations: Intertek)
cf. World Vol.64 (U.K., U.S., etc.)

ツイッター検索で日英両国関連につき出て来たもの(Brexit関連は多くありません)を取り急ぎ以下貼っておきます。多数見つかりましたので Vol.33 に続きます。

Vol.33 に続きます。 Please go on to Vol.33. It was a good surprise that I was able to easily find many tweets regarding Japan-Scotland.

#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.
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)


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

Australia オーストラリア Vol.10(pharmaceutical corporations 製薬会社)

All the below links and tweets are in English.


Pennsylvania Vol.11 (corporations: CSL Behring) / Australia Vol.29
UK Vol.173 (pharmaceutical corporations: Seqirus) / Australia Vol.30


ツイッター検索で 上記製薬会社名 及び Japan や 日本の5製薬会社各社名 を入れて出て来たもの

U.K. イギリス Vol.31(pharmaceutical corporations 製薬会社)

All the below link and tweets are in English.


UK Vol.170 (pharmaceutical corporations: GlaxoSmithKline)


ツイッター検索で 上記製薬会社名 及び Japan や 日本の5製薬会社各社名 を入れて出て来たもの

World 世界情勢等 Vol.7

All the below links are in English.


World Vol.51
World Vol.50
World Vol.49
World Vol.48
World Vol.47
World Vol.46
World Vol.45
World Vol.44
World Vol.43
World Vol.42
World Vol.41