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Regulatory Focus™ > News Articles > 2021 > 10 > Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet wi

Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows

Posted 25 October 2021 | By Michael Mezher 

Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden meets with top FDA candidate (Politico)
  • FDA Says Pfizer Vaccine’s Benefits Outweigh Key Risks in Children 5 to 11 (NYTimes) (STAT)
  • Moderna says its COVID-19 vaccine protective, safe in young children (Reuters) (STAT)
  • US to invest $70 mln to boost access to COVID-19 tests (Reuters)
  • Bausch, Clearside receive US approval for eye injection (Reuters)
  • Analysis: Drug pricing reform opponents win most pharma lobbying money (Reuters)
  • Drug pricing talks heat up as Democrats work to win over skeptics (STAT) (Politico)
  • Bristol-Myers Makes Takeover Approach to Aurinia Pharmaceuticals (Bloomberg)
  • Roche's refillable eye implant becomes Eylea's latest threat (BioPharmaDive) (Endpoints)
  • Millions of used, substandard medical gloves imported into US: report (The Hill)
In Focus: International
  • Covax falters as rich countries buy up Covid vaccines (FT)
  • EU regulator starts real-time review of Merck's COVID-19 pill (Reuters) (EMA)
  • Roche launches genomic profiling kit to ease cancer research (Reuters)
  • S.Africa's Aspen aims to sharply increase COVID-19 vaccine capacity (Reuters)
  • Novartis lung cancer drug fails another Phase III trial (Reuters)
  • Merck receives first breast cancer approval in Europe for Keytruda (PMLive)
  • Antitrust: Commission carries out unannounced inspections in the animal health sector in Belgium (EC)
Coronavirus Pandemic
  • Indonesia in talks to buy Merck's COVID-19 antiviral pill – minister (Reuters)
Pharma & Biotech
  • Xilio Therapeutics goes public as biopharma IPOs rumble forward in Q4 (Endpoints)
  • After passing on Acceleron, Bristol Myers eyes bolt-on acquisition of autoimmune specialist — report (Endpoints)
  • Sanofi, Regeneron gear up for new Dupixent filing after clearing second PhIII for eosinophilic esophagitis (Endpoints)
  • Rise in prices of APIs and KSMs impacts industry badly (Pharmabiz)
  • Simmering feud between bluebird and a rival continues with allegations of patent fraud (Endpoints)
  • Avenue Therapeutics lands an FDA adcomm for troubled flagship drug; FDA approves eye injection treatment for fluid buildup (Endpoints)
  • Accelerated Approval’s Double-Edged Sword Cuts Down Agenus’ Balstilimab BLA (Pink Sheet)
  • Endo taps bent veggie in first Xiaflex brand campaign for Peyronie's disease curved erection condition (Endpoints)
  • AstraZeneca veteran takes up CEO post at Medivir, becoming 4th person to hold the post in quick succession (Fierce)
  • A combo of AstraZeneca's Imfinzi and chemo wins where others have failed in pivotal biliary tract test (Endpoints)
  • Merck's experimental HIV drug islatravir hits with a PhIII combo win and FDA filing plans (Endpoints)
  • Intellia, LogicBio fuel hope for in vivo gene editing with new animal data in rare diseases: report (Fierce)
  • A transatlantic biotech flags a painful PhIII cancer flop, waving a white flag (Endpoints)
  • Another NASH player retreats from battered field after toxicology study flags potential delay (Endpoints)
  • Zimmer, J&J chase Stryker's lead in ortho robotics (MedtechDive)
  • With Sanofi still on board, Click Therapeutics closes $52M series B for digital therapeutics in depression, chronic pain and more (Fierce)
  • Recent court decision pushes FDA to reject and reclassify drug-device combo, crushing shares (Endpoints)
Government, Regulatory & Legal
  • Third juror dismissed in Elizabeth Holmes trial after found playing Sudoku (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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