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.