Recon: Pfizer, BioNTech to test universal coronavirus vaccine; ARCH raises $3B fund for biotech startups

| 29 June 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

• FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant (Endpoints) (STAT) (Reuters) (The Pink Sheet)
• FDA: Don’t rush a move to change the Covid-19 vaccine composition (STAT)
• BioNTech, Pfizer to start testing universal vaccine for coronaviruses (Reuters)
• US Health Officials Announce New Monkeypox Vaccination Plan (Bloomberg) (Reuters) (Washington Post)
• Sanofi to cut insulin prices for uninsured from $99 to $35, matching the insulin cap coming through Congress (Endpoints) (Reuters)
• Spero’s Fast-Tracked Antibiotic Drug Candidates for Complicated UTIs Hits Snag (FDAnews)
• 100 lawmakers ask HHS to use controversial federal laws to combat high drug prices (STAT)
• Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process (The Pink Sheet)
• US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade (The Pink Sheet)
• Lilly to Sell Additional 150,000 Doses of Covid Antibody to US (Bloomberg) (Reuters)
• Diversity Push for Clinical Trials Prompts House Panel Look (Bloomberg)
• Foreign Influence in NIH Research Gets Lawmakers’ Attention (Bloomberg)

In Focus: International

• EU Targets Generics, Inspection Shortfalls & Environmental Assessments (The Pink Sheet)
• England: HTA Body NICE Makes Big RWE Push (The Pink Sheet)
• WHO warns 'sustained transmission' of monkeypox risks vulnerable groups (Reuters)
• Europe to buy 110k doses of Bavarian Nordic's monkeypox vaccine — as EU-licensed vaccine not easily accessible (Endpoints)
• EU's von der Leyen can't find texts with Pfizer chief on vaccine deal -letter (Reuters)
• COVID cases spike in Americas, South America worst hit -PAHO (Reuters)
• EU proposes ban on flavoured heated tobacco products (Reuters)
• British Columbia reaches $116 mln settlement with Purdue Pharma over opioid crisis (Reuters)
• S.Korea approves first domestically developed COVID vaccine (Reuters)
• Taiwan to receive first doses of Novavax COVID vaccine this week (Reuters)

Pharma & Biotech

• ARCH Venture Partners raises $3 billion fund to invest in biotech startups despite brutal stock downturn (STAT) (Fierce) (Biospace)
• Santhera's clinical data are in, but NDA delayed 4-6 months by third party manufacturer (Endpoints)
• After FDA efforts finally get rolling, Santhera DMD drug sidelined by manufacturing delay (Fierce)
• Covid Vaccine Maker BioNTech Plans to Target Superbugs Next (Bloomberg)
• Reeling from Covid flop, Icosavax says its RSV candidate passed early test. But investors need some more convincing (Endpoints)
• As bear market continues to beat down biotech, ARCH closes a $3B early-stage fund (Endpoints)
• Bayer opens $140M cancer research center, adds 50 jobs in hopes of becoming top oncology company (Fierce)
• Oyster Point Laying Off 50 with Focus on Dry Eye Drug Launch (Biospace)
• Placebo response reveals unconscious bias among white patients toward female, Black physicians (STAT)
• GSK Poaches Top AstraZeneca Dealmakers to Boost Drug Pipeline (Bloomberg)
• Fauci Suffers Covid Symptom Rebound After Course of Pfizer’s Paxlovid (Bloomberg)

Medtech

• Philips attributes foam breakdowns in recalled ventilators to ozone-based cleaners (Fierce)
• Siemens Healthineers to hold on to ultrasound division – CFO (Reuters)
• Bayer launches digital AI marketplace for analyzing CT, MRI scans (Fierce)
• Merck launches healthcare startup incubator for AI developers (Fierce)
• Schrodinger to launch first human trial of its computer-designed blood cancer drug (Fierce)

Government, Regulatory & Legal

• Sanofi Says Taxotere Eye Injury Suires Meritless, Preempted (Bloomberg)
• Texas AG Investigates Walmart’s Opioid Sales Practices (Law360)

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.