Recon: FDA staff signal support for Sanofi-Astra-Zeneca RSV vaccine; EMA backs WHO’s COVID vaccine update recommendation

• FDA Announces Additional Steps to Modernize Clinical Trials (FDA)
• Illumina appeals FTC’s order to divest Grail with plea for cancer screening test (MedtechDive)
• Merck sues US government to halt Medicare drug price negotiation (Reuters) (NYTimes) (STAT)
• Medicare taps acting official to head up its new drug price negotiations (STAT)
• Merck's CMV drug is approved for kidney transplant patients (Endpoints)
• CBER's Peter Marks shares pandemic lessons as FDA continues 'going through the backlog' (Endpoints)
• Novavax exec says its new COVID shot should work against variants on the rise (Reuters)
• Sanofi-AstraZeneca's preventive RSV therapy appears safe- FDA staff (Reuters)
• White House vows an improved effort against drug overdoses (Reuters)
• Novocure's lung cancer device study raises concerns around commercial use (Reuters)
• Illumina appeals FTC order to divest cancer test maker Grail (Reuters)

• EU regulators back WHO's COVID vaccine update recommendation (Reuters) (EMA)
• Canada Proposes List Of ‘Critical Products’ & More Agile Regulation To Address Shortages (Pink Sheet)
• GSK CEO Emma Walmsley talks about vaccines, M&A and the company’s future (Endpoints)
• EU Regulatory Reforms Mean Many Orphan Drug Producers Won’t Benefit From Incentives (Pink Sheet)
• Eisai hit with ransomware attack, launches investigation into possible data leaks (Fierce)
• Germany's Bayer faces shortage of contraceptive pill Yasmin in India (Reuters)
• Sri Lanka to reduce drug prices by 16% as crisis eases (Reuters)

• Antibiotic maker Paratek, low on cash, agrees to a buyout (BioPharmaDive)
• GSK's cancer drug Jemperli gets file acceptance from US FDA (Reuters)
• Biogen board and C-suite are in step as they eye M&A opportunities, new CEO says (STAT)
• Ultragenyx brittle bone drug barrels into pivotal trial after triggering swift improvements in phase 2 (Fierce)
• Biotech’s trade secrets face growing threat from foreign influences, science leaders warn (STAT)
• Acepodia's off-the-shelf cell therapies get another $100M for oncology trials (Endpoints)
• Bain leads $150M round to push blindness biotech's rare disease drug toward FDA (Endpoints)
• Daiichi Sankyo scores first nod for IV iron replacement drug in patients with heart failure (Endpoints)
• Canadian biotech narrows trial population to lift solid tumor drug out of FDA hold (Fierce)
• Amgen continues to target mid-December deadline for Horizon deal close (Endpoints)
• Erasca touts early colorectal cancer data, trims a slate of trials and preclinical programs to refine focus (Endpoints)
• Idorsia notes potential $440.8M Asia licensing deal to extend cash runway amid slow Quviviq sales (Endpoints)

Medtech

• Philips faces new recall of Evo respirators, tagged Class I by FDA (MedtechDive)

Government, Regulatory & Legal

• Medtronic Loses Catheter Patent Fight At Fed. Circ. (Law360)