Recon: FDA mulls second COVID booster; GSK pauses some RSV vax trials

• FDA Eyes Second Covid-19 Booster Shot (WSJ)
• Pfizer’s Covid-19 Vaccine for Kids Isn’t Working Well Against Omicron So Far, Delaying FDA Review (WSJ)
• FDA Looking For A Few Good Contractors To Guide Digital Modernization (Medtech Insight)
• Still Mulling EUA Transition Options? Don’t Wait Too Long, Attorney Says (Medtech Insight)
• Teva takes 'skinny' label dispute with GlaxoSmithKline to the Supreme Court: reports (Fierce)
• Citing safety signal, GSK pauses some trials of new RSV vaccine (Biopharma Dive)
• FDA starts probe into a clinical trial death as next-gen CAR-T researchers stop enrollment (Endpoints)

• ICH Leadership Aims To Bring Patient Perspectives Into Global Guideline Development Process (Pink Sheet)
• African countries to get mRNA vaccine technology in WHO project (Reuters)
• Dutch HTA Calls For Better Funding For Orphan Data Collection (Pink Sheet)
• S. Africa's Ramaphosa: COVAX must buy vaccines from local manufacturing hubs (Reuters)
• Moderna's South African Patent Filings Raise Activists' Alarms (Law360)
• Sandoz launches generic Revlimid in 19 countries in Europe, opening a flood of competition for BMS' megablockbuster (Fierce)

• Valneva receives 12.5 mln pound COVID-19 vaccine manufacturing grant in Scotland (Reuters)
• Canada approves Novavax's COVID-19 vaccine for adults (Reuters)
• FDA to allow export of AstraZeneca COVID vaccine lots made at Emergent plant (Reuters)
• The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects (NYT)
• FDA updates Merck's Covid-19 pill EUA and reaffirms it should only be used as a last resort (Endpoints)

• Bristol Myers gets FDA decision date for earlier use of CAR-T therapy (Biopharma Dive)
• BioMarin gene therapy could be on hold 'for several quarters' after FDA mandates new preclinical tests (Endpoints)
• Sanofi, Regeneron ditch Dupixent trial in patients who failed Novartis and Roche's Xolair for hives condition (Fierce)
• AstraZeneca boosts oncology credentials with breast cancer trial success (Reuters)
• J&J Units Aim To Hit Brakes On Generic Schizophrenia Drug (Law360)
• Synairgen therapy fails in late-stage study in COVID patients; shares sink (Reuters)
• Drug developer Atara says cancer therapy trial paused after patient death (Reuters)
• Bayer lifts peak sales estimate for prostate cancer drug (Reuters)
• Unilever’s $68 Billion Health Kick Is the Wrong Remedy (WSJ)
• Agios wins FDA approval for drug to treat rare form of anemia (Stat)
• J&J lands Tremfya one-two punch in IBD with first ulcerative colitis win and long-term Crohn's data (Fierce)
• How an OTC cough med could serve as a steppingstone for creating heart rhythm drugs (Fierce)
• FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data (Fierce)

• Medtronic talks diabetes group's FDA warning letter, new products, supply chain constraints (Medtech Dive)
• To keep up with demand, Sorrento acquires majority ownership in Covid-19 test manufacturer (Endpoints)
• Omnipod gets in the game with diabetes-themed island in ‘Animal Crossing’ (Endpoints)
• Prenatal Defect Test Maker Hit With Suit Over False Positives (Law360)
• InfraScan wins FDA OK for its handheld brain bleed detector for children (Fierce)
• FDA hands down Class I rating to Vyaire Medical's ventilator recall (Fierce)

• J&J unit proposes independent exam if it remains in bankruptcy (Reuters)
• Purdue's Sackler owners propose up to $6 billion opioid settlement (Reuters)
• Attys From Four Firms Named To Co-Lead Philips CPAP MDL (Law360)
• J&J back in court over new generic threat from Intas, just months after fending off Teva (Endpoints)
• Buyers Hit Abbott Labs With Baby Food Suit Amid FDA Probe (Law360)
• USPTO Webinar on Biopharma Patents in China (Patent Docs)