Recon: Canada Authorizes J&J COVID Vaccine; FDA warns against accuracy of fever scanner

Posted on March 05, 2021 | Through Michel mezher

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

Focus: United States

  • Woodcock interview on COVID-19 tests and vaccines (NPR)
  • What to look for in Lilly’s highly anticipated Alzheimer’s disease data (STAT)
  • Abbott’s test to distinguish between coronavirus and influenza viruses obtains US clearance (Reuters)
  • FDA Approves Roche’s Actemra / RoActemra Treatment for Rare Lung Disease (Pharmafile)
  • Monkeys at the San Diego Zoo receive an experimental animal vaccine against the coronavirus. (NY Times)
  • Popular drug does not relieve mild symptoms of Covid-19, study finds (NY Times)
  • FDA inspection problems will increase if the agency does not resolve the COVID-19 backlog: GAO (Fierce)
  • Pfizer’s problem-prone McPherson plant, which is currently increasing its vaccine supplies, was cited for persistent violations in early 2020 (End points)
  • Those fever scans that everyone uses to fight covid can be extremely inaccurate, researchers say (Washington post) (FDA)
  • Senate begins debate on Biden’s $ 1.9 trillion COVID-19 aid proposal (Reuters)

Focus: international

  • Canada Approves J & J’s COVID-19 Vaccine, Says Benefits Outweigh Risks (Reuters) (The hill) (Health Canada)
  • Australia urges EU to review AstraZeneca vaccine block (Reuters) (NPR)
  • Britain tells EU: vaccine export restrictions endanger fight against COVID (Reuters)
  • EU regulator advises use of Lilly’s COVID-19 antibody cocktail (Reuters)
  • Largest vaccine maker warns of delays as US prioritizes Pfizer (Bloomberg) (Economic times)
  • An Oxford study indicates that AstraZeneca is effective against the Brazilian variant, according to a source (Reuters)
  • Sinovac vaccine may not elicit sufficient antibody response to Brazil variant: study (Reuters)
  • China will develop vaccines against major infectious diseases plan -2021-2025 (Reuters)
  • South Korea Approves Pfizer Covid-19 Vaccine: Ministry of Drug Safety (Reuters)
  • Drugmaker Takeda asks Japan for approval of Moderna COVID-19 shot (Reuters)
  • WHO considers the risk of Ebola to be “very high” for Guinea’s neighbors (Reuters)

Coronavirus pandemic

  • Head of the WHO: give up patents on Covid vaccines to put the world on “war footing” (The Guardian)
  • Some scientists question the WHO investigation into the origins of the coronavirus pandemic (NY Times)
  • WHO investigators will discard plans for an interim report on the probe of the origins of Covid-19 (WSJ)
  • United States in talks with allies to counter Chinese vaccine diplomacy (The hill)
  • NIH stops testing for Brii’s COVID-19 antibodies in patients hospitalized for futility (Fierce)
  • Apellis Stops COVID-19 Program After Missing Mortality Criterion (Fierce)
  • UK COVID-19 trial finds no benefit of gout drug in hospitalized adults (Reuters)
  • France could block vaccine deliveries, like Italy: Veran (Reuters)
  • Germany has so far no reason to stop vaccine deliveries: the Minister of Health (Reuters)
  • Brazil in talks for 63 million Moderna COVID-19 shots by January 2022: document (Reuters)
  • China’s COVID-19 vaccine production capacity could cover 40% of the population by mid-2021: responsible for disease control (Reuters)
  • The Italian region of Lazio calls on the government to consider producing the Sputnik V COVID-19 vaccine (Reuters)
  • Iraq signs agreement to receive Russian vaccine Sputnik V (Reuters)
  • Pakistani health workers hesitate over Sinopharm vaccine, poll finds (Reuters)
  • Denmark will administer the AstraZeneca vaccine to people over 65 (Reuters)
  • Rwanda becomes first African country to use Pfizer COVID-19 vaccine (Reuters)
  • South Africa in African Union talks on COVID-19 shootings for 10 million people (Reuters)
  • South African regulator says it is at an advanced stage of review of the Pfizer vaccine (Reuters)

Pharma & Biotech

  • Ecuador grants compulsory license to anti-HIV drug raltegravir (KEI)
  • European industry excluding patents denounces price reductions and recoveries (Pink sheet)
  • Roche is preparing to destroy an Irish factory, and it’s complicated (Fierce)
  • The MHLW announces the prices of new drugs for the first off-year review in April (PharmaJapan)
  • Biogen is making gene therapy ambitions a reality with a $ 200 million plant in the Research Triangle (Fierce)
  • AbbVie sells its UK site for $ 119 million to Chinese cell and gene therapy player Pharmaron (End points)
  • Patient-focused drug development and complex trial design may not get more funding in PDUFA VII (Pink sheet)
  • Spending on orphan drugs: could the sequence of indications offer a price policy solution? (Pink sheet)
  • Pfizer and Bayer will withdraw “G1” products with high generic erosions (PharmaJapan)
  • India to Abolish Intellectual Property Appeal Board: Should Pharmacy Be Worried? (Pink sheet)
  • One year after the start of the Sanofi overhaul, CEO Paul Hudson receives 11.34 million euros in 2020, including this signing bonus (Fierce)
  • Seagen Warns Investors Against TRC Capital’s Latest ‘Mini Takeover Offer’; BeiGene is looking for a new indication for the best PD-1 player (End points)
  • Not 3 weeks after making Humacyte public, Rajiv Shukla is launching another blank check company (End points)
  • Genentech becomes director of clinical development by appointing Lilli Petruzzelli; Paul Sekhri crowns an eventful week by appointing Sapna Srivastava CFO of eGenesis (End points)
  • An Array co-founder reappears as CEO of a small college company, seeking to remake an old class of cancer drugs (End points)

Medtech

  • J&J Loses Appeal in Australian Pelvic Mesh Class Action (Reuters)
  • MDCG and subgroup meetings – 2021 (THIS)
  • Agilent will purchase Resolution Bio, a cancer blood tester, in a $ 695 million deal (Fierce)
  • Germany approves new digital mental health app for prescribing (mobihealthnews)

Government, Regulation and Legal

  • New legislation to support drug substitutions (ATG)
  • The FDA seeks success over compound drug agreements (Law360)
  • DOJ’s ‘troubling’ theory wins over Walmart allies in opioid case (Law360)
  • Brand name drugs may be preferred by physicians and patients, but Medicare Part D is very expensive (STAT)
  • ‘Pharma Bro’ Shkreli hit with the first private antitrust lawsuit (Law360) (Pink sheet)
  • Endo to rework $ 3.3 billion loan as opioid litigation looms (Bloomberg)
  • Germ-X ​​Maker Beats Hand Sanitizer False Ad Suit, for now (Law360)
  • Marlboro maker Altria asks FDA to spread the word that nicotine doesn’t cause cancer (CNBC)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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