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March 5, 2021
by Michael Mezher

Recon: Canada authorizes J&J COVID vaccine; FDA cautions on fever scanner accuracy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Woodcock Interview on COVID-19 Tests and Vaccines (NPR)
  • What to look for in Lilly’s eagerly awaited Alzheimer’s data (STAT)
  • Abbott's test to distinguish coronavirus and flu viruses gets US authorization (Reuters)
  • FDA approves Roche’s Actemra/RoActemra treatment for rare lung disease (Pharmafile)
  • San Diego Zoo apes get an experimental animal vaccine against coronavirus. (NYTimes)
  • Popular Drug Does Not Alleviate Mild Covid-19 Symptoms, Study Finds (NYTimes)
  • FDA's inspection woes to grow if agency doesn't address COVID-19 backlog: GAO (Fierce)
  • Pfizer's trouble-prone McPherson plant — now ramping up vaccine supplies — was cited for continuing violations in early 2020 (Endpoints)
  • Those fever scanners that everyone is using to fight covid can be wildly inaccurate, researchers find (Washington Post) (FDA)
  • Senate starts debate on Biden's $1.9 trillion COVID-19 aid proposal (Reuters)
In Focus: International
  • Canada approves J&J's COVID-19 vaccine, says benefits outweigh risks (Reuters) (The Hill) (Health Canada)
  • Australia asks EU to review block of AstraZeneca vaccine (Reuters) (NPR)
  • Britain tells EU: Vaccine export restrictions endanger COVID fight (Reuters)
  • EU regulator advises on use of Lilly's COVID-19 antibody cocktail (Reuters)
  • Largest Vaccine Maker Warns of Delays as US Prioritizes Pfizer (Bloomberg) (Economic Times)
  • Oxford study indicates AstraZeneca effective against Brazil variant, source says (Reuters)
  • Sinovac vaccine may not trigger sufficient antibody response to Brazil variant: study (Reuters)
  • China to develop vaccines against major infectious diseases -2021-2025 plan (Reuters)
  • South Korea approves Pfizer covid-19 vaccine: drug safety ministry (Reuters)
  • Drugmaker Takeda asks Japan for Moderna COVID-19 shot approval (Reuters)
  • WHO sees Ebola risk as "very high" for Guinea's neighbours (Reuters)
Coronavirus Pandemic
  • WHO chief: waive Covid vaccine patents to put world on 'war footing' (The Guardian)
  • Some Scientists Question W.H.O. Inquiry Into the Coronavirus Pandemic’s Origins (NYTimes)
  • WHO Investigators to Scrap Plans for Interim Report on Probe of Covid-19 Origins (WSJ)
  • US in talks with allies to counter China's vaccine diplomacy (The Hill)
  • NIH stops trial of Brii's COVID-19 antibodies in hospitalized patients for futility (Fierce)
  • Apellis stops COVID-19 program after missing mortality endpoint (Fierce)
  • UK COVID-19 trial finds no benefit of gout drug in hospitalised adults (Reuters)
  • France could block vaccine shipments, similar to Italy: Veran (Reuters)
  • Germany has so far had no reason to stop vaccine shipments: health minister (Reuters)
  • Brazil in talks for 63 million Moderna COVID-19 shots by Jan 2022: document (Reuters)
  • China's COVID-19 vaccine production capacity may cover 40% of population by mid-2021: disease control head (Reuters)
  • Italy's Lazio region asks government to consider producing Sputnik V COVID-19 vaccine (Reuters)
  • Iraq signs deal to receive Russia's Sputnik V vaccine (Reuters)
  • Pakistan health workers hesitate over Sinopharm vaccine, poll says (Reuters)
  • Denmark to give AstraZeneca vaccine to over-65s (Reuters)
  • Rwanda becomes first African nation to use Pfizer COVID-19 vaccine (Reuters)
  • South Africa in African Union talks on COVID-19 shots for 10 million people (Reuters)
  • S.Africa regulator says at advanced stage of Pfizer vaccine review (Reuters)
Pharma & Biotech
  • Ecuador grants compulsory license over HIV drug raltegravir (KEI)
  • European Off-Patent Industry Decries Price Cuts And Clawbacks (Pink Sheet)
  • Roche is gearing up to knock down an Irish plant—and it's complicated (Fierce)
  • MHLW Announces New Drug Prices for 1st Off-Year Revision in April (PharmaJapan)
  • Biogen cements gene therapy ambitions with $200M factory in Research Triangle (Fierce)
  • AbbVie offloads UK site for $119M in sale to Chinese cell and gene therapy player Pharmaron (Endpoints)
  • Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII (Pink Sheet)
  • Orphan Drug Spending: Could Sequence Of Indications Offer Pricing Policy Solution? (Pink Sheet)
  • Pfizer, Bayer to Pull Plug on “G1” Products with High Generic Erosions (PharmaJapan)
  • India To Scrap Intellectual Property Appellate Board: Should Pharma Worry? (Pink Sheet)
  • A year into Sanofi's revamp, CEO Paul Hudson collects €11.34M in 2020 pay—including that signing bonus (Fierce)
  • Seagen warns investors against TRC Capital’s latest 'mini-tender offer'; BeiGene goes after a new indication for top PD-1 player (Endpoints)
  • Not 3 weeks after taking Humacyte public, Rajiv Shukla launches another blank check company (Endpoints)
  • Genentech gains clinical development exec by appointing Lilli Petruzzelli; Paul Sekhri caps eventful week, naming Sapna Srivastava CFO of eGenesis (Endpoints)
  • An Array co-founder re-emerges as CEO of a small academic spinout, looking to remake an old class of cancer drugs (Endpoints)
Medtech
  • J&J loses appeal in Australian pelvic mesh class action (Reuters)
  • Meetings of MDCG and subgroups – 2021 (EC)
  • Agilent to pick up cancer blood tester Resolution Bio in $695M deal (Fierce)
  • Germany approves new digital mental health app for prescription (mobihealthnews)
Government, Regulatory & Legal
  • New legislation to support medicine substitutions (TGA)
  • FDA Seeks Win In Suit Over Compounded Drug Agreements (Law360)
  • DOJ's 'Troubling' Theory Gains Walmart Allies In Opioid Case (Law360)
  • Physician and patients may prefer brand-name drugs, but they cost Medicare Part D a lot of money (STAT)
  • 'Pharma Bro' Shkreli Hit With 1st Private Antitrust Suit (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 the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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