Recon: Pfizer to acquire Biohaven for $11.6B; Emergent’s manufacturing problems worse than previously known

| 10 May 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Cash-rich Pfizer to pay $11.6 bln for Biohaven in biggest deal since 2016 (Reuters) (STAT) (FT)
  • Walgreens, CVS, Walmart begin $878 million opioid trial in Ohio (Reuters)
  • Emergent's Covid vaccine problems more extensive than previously known (Politico) (NYTimes)
  • Inside the sales machine of the ‘kingpin’ of opioid makers (Washington Post)
  • Novavax shares slide 20% on COVID vaccine demand uncertainty (Reuters)
  • With spotlight on FDA, Congress weighs reforms to accelerated drug approvals (BioPharmaDive)
  • Eisai wraps filing for Biogen-partnered Aduhelm follow-up, hoping to regain 'credibility and trust' (Fierce)
  • The DOJ is investigating whether mental-health startup Cerebral violated a controlled-substances law (Business Insider)
In Focus: International
  • BioNTech completes Phase II trial of COVID-19 vaccine in China (Reuters)
  • GE unit boosts medical dye output as China COVID lockdown cuts supplies (Reuters)
  • Bayer's pharma business feels the pain from Xarelto generics in China (Fierce)
  • Boots, Superdrug and other chemists report hay fever pill shortages (The Guardian)
  • Novo Nordisk allies itself with one of the buzziest groups in biotech, launching a multi-pronged attack at discovering new drugs (Endpoints)
  • Homegrown mRNA Thai vaccine for Covid-19 could be ready by year end — report (Endpoints)
Pharma & Biotech
  • Flagship Pioneering hires lobbyists, a first among biotech venture firms (STAT)
  • Telehealth aims to crack open Paxlovid’s prescription bottleneck (STAT)
  • Trying to avoid a CRL? New FDA draft guidance talks benefit-risks on quality assessments (Endpoints)
  • FibroGen CEO: Roxa path blocked as AstraZeneca remains undecided on just what it plans to do in the wake of a CRL (Endpoints)
  • As Sanofi prunes pipeline, ex-Alexion crew at Rallybio picks up anemia drug (Endpoints)
  • Sesen Bio reports progress with regulators as it preps for new cancer trial, but issues remain (Fierce)
  • Petros picks 505(b)(2) pathway for topical rival to Endo therapy (Fierce)
  • Idorsia drug fails to quell binge eating in midphase trial, driving biotech to abandon the indication (Fierce)
  • Against a historic market downturn, Moma Therapeutics raises $150M for precision cancer research (BioPharmaDive)
  • Toxins In Silicone Tubing Leads To FDA Warning About Hemodialysis Machines Made By Fresenius (MedtechInsight)
  • J&J Medtech Appoints Kurt Van den Bosch As CFO (MedtechInsight)
  • Hot Topics On The EU’s Immediate Regulatory Agenda: Six Documents To Endorse (MedtechInsight)
  • EU Notified Bodies Told To Comply With Russia/Belarus Sanctions (MedtechInsight)
Government, Regulatory & Legal
  • ‘It’s a tsunami’: Legal challenges threatening public health policy (Politico)
  • Illumina forced to pay almost $334M as it loses DNA sequencing patent case (Endpoints)
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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