Recon: US ups Moderna vaccine contract; Pfizer buys Amplyx
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
US govt boosts Moderna COVID-19 vaccine contract to $1.25B (Reuters ) (Endpoints )
US probing two new blood clot cases after J&J's COVID-19 vaccine (Reuters ) (Press )
Pfizer buys Amplyx to expand drug-resistant treatment portfolio (Reuters ) (Endpoints )
Top US trade negotiator discussed vaccine ramp-up with Novavax exec (Reuters )
Novavax shares jump after Biden says focusing on its vaccine (Reuters )
CDC has not seen link between heart inflammation and COVID-19 vaccines (Reuters )
Pfizer’s new at-home pill to treat Covid could be available by end of the year, CEO hopes (CNBC )
Warren asks SEC to investigate share sales by Emergent CEO (Letter )
Biden’s Covid team split over decision to send vaccine doses abroad (Politico )
Tech glitches overshadow FDA oncology adcomm as a solid majority of advisers vote to keep Roche's Tecentriq in mTNBC (Endpoints ) (Fierce )
In Focus: International
Brazil health regulator rejects Russia's Sputnik vaccine (Reuters ) (NYTimes ) (WSJ )
Russia's Sputnik V developers reject Brazil's criticisms (Reuters ) (FT )
Canada PM says AstraZeneca vaccine is safe, despite blood clot death (Reuters 1 , 2 )
EU demands immediate access to UK-made vaccines in AstraZeneca legal battle (Reuters )
Waivers for vaccine production “not a solution” – BioNTech (Reuters )
Teva Pharm unlikely to reach deals to co-produce vaccines -CEO (Reuters ) (FT )
Nestle staff sought to help Lonza production for Moderna vaccine (Reuters )
Coronavirus Pandemic
Indians rush for vaccines as coronavirus toll tops 200,000 (Reuters )
Syngene targets delivering 500,000 vials of remdesivir in India as COVID-19 surges (Reuters )
How Europe Sealed a Pfizer Vaccine Deal With Texts and Calls (NYTimes )
UK orders 60m more doses of Pfizer Covid vaccine for booster jabs (The Guardian )
Doctors More Likely to Prescribe Opioids to Covid ‘Long Haulers,’ Raising Addiction Fears (KHN )
U.S. drugmakers step up supplies as India battles COVID-19 surge (Reuters )
EU official warns of risks of disjointed COVID vaccine records (Reuters )
Mexico agrees domestic production of Russia's Sputnik V vaccine (Reuters )
Pharma & Biotech
Empire of Pain — the story of the Sacklers and OxyContin (FT )
Investment in antimicrobials was up in 2020, but much work remains (STAT )
Opinion: Meaningful drug pricing reforms are headed nowhere fast (Endpoints )
GSK chief defends against accusations of flat performance (FT )
Wall Street fears Amgen's tough first quarter is just the start (BioPharmaDive )
Industry cooperation to fight counterfeiting expanded (EC )
John C. Martin, 69, Dies; Led Drugmaker in Breakthroughs (NYTimes )
BsUFA III Talks Begin With Regulatory Science Disagreement (Pink Sheet )
Trillium moves ‘don’t eat me’ cancer drug into new studies, but future clouded by modest tumor responses (STAT )
SoftBank leads funding that could net up to $525M for Exscientia's AI drug platform (Fierce )
Sanofi plans 2021 restart for pediatric hemophilia trial hit by fallout from thrombotic events (Fierce )
Ohana, Flagship's big bet on fertility treatments, shuts down and lays off staff after VC pulls the plug (Endpoints )
BioMarin partners with Allen Institute to develop gene therapies for the brain (BioPharmaDive )
Fueled with a fresh half-billion dollars as AI investments boom, Exscientia is hitting the gas on drug development (Endpoints )
What caused Roche's Huntington's drug tominersen to hit the skids in late-stage test? It's complicated, analysts say (Endpoints )
Boundless Bio raises $105M in effort to reimagine targeted cancer therapy (Endpoints )
Sanofi reports sales growth amid Dupixent's China launch, but reveals PDUFA delay in Pompe disease program (Endpoints )
BeiGene's late stage trial shows promising numbers; Amgen to study sotorasib dosage after FDA recommendation (Endpoints )
PureTech turns 200-year-old discovery into a new approach to Alzheimer's, while clinging to controversial amyloid hypothesis (Endpoints )
Medtech
A decades-long fight over an electric shock treatment led to an FDA ban. But the fight is far from over. (NBC )
From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments (MedtechInsight )
PPD sees major sales jump for its last financial update, as Thermo Fisher begins buyout (Fierce )
Edwards Stays On Track For ‘Mid-Teens’ TAVR Growth In 2021 (MedtechInsight )
GE Healthcare grows sales as routine screening, elective procedures return (MedtechDive )
Stryker's Wright costs spur Q1 miss, but robotics orders pick up (MedtechDive )
TFDA makes further announcements regarding new medical device regulations and fees (Emergo )
Roche extends blood test reach with sweeping new use claims in Type 2 diabetes, heart attack risk and more (Fierce )
Government, Regulatory & Legal
FDA readies plan to bar menthol cigarettes nationwide (Politico )
GSK Loses Bid To Get US FDA To Change Zofran Label, But May Prevail On Preemption Defense Anyway (Pink Sheet )
US FDA Takes Star Turn In Recent Product Liability Lawsuits (Pink Sheet )
Indivior ponies up $300M to put Suboxone marketing allegations to bed (Fierce )
Fed. Circ. Says J&J Unit's HIV Treatment May Enter Duty-Free (Law360 )
Endo Says FTC Is Overreacting To Latest Impax Opioid Deal (Law360 )
PTAB Slashes 2 Bio-Rad DNA Patents In 10X Genomics Fight (Law360 )
AGs Warn Against Sanctioning Calif. In Generics Pricing MDL (Law360 )
SDNY Dismisses Hernia Mesh Claims (Drug & Device Law )
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.
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