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)
- 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)
- Indonesia in talks to buy Merck's COVID-19 antiviral pill – minister (Reuters)
- 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)
- Third juror dismissed in Elizabeth Holmes trial after found playing Sudoku (CNBC)
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