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April 28, 2021
by Michael Mezher

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.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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