Recon: Senate expected to vote on Califf nomination next week; Top drugs in danger of losing patent protection

• Senate to vote on Califf nomination next week (Senate) (Twitter)
• FDA panel to discuss lung cancer drug tested only in China (Reuters)
• 10 million doses to be quickly rolled out if vaccine for young children is recommended (Washington Post)
• Bayer gets FDA fast track status for next-generation blood thinner (Reuters)
• FDA denies Ardelyx’s appeal against kidney drug reception, hammering another nail in tenapanor’s coffin (Fierce)
• With Pazdur preparing to lower the boom on its PD-1, Eli Lilly spells out the deep discount on offer (Endpoints)
• Biden calls on Senate to pass his agenda to lower drug prices (The Hill)
• Aduhelm Medicare Coverage: House Republicans Push For CMS To Collaborate With US FDA (The Pink Sheet)
• Marching in again? Latest Xtandi petition raises questions on if NIH has changed its tune (Endpoints)
• Teva execs claim mixed winning streak in pricey opioids court battle -- as permanent peace remains elusive (Endpoints)
• CDC Proposes New Guidelines for Treating Pain, Including Opioid Use (NYT) (STAT)

• Japan Health Ministry committee approves Pfizer oral COVID-19 drug (Reuters)
• UK MHRA Explains How To Navigate Post-Brexit Regulatory Complexities (The Pink Sheet)
• European Countries Focus Horizon Scanning On Alzheimer’s Disease (The Pink Sheet)
• AstraZeneca dumps late-phase, next-gen COVID-19 vaccine, calling time on a beta player in an omicron world  (Fierce)
• In final analysis, J&J's underdog vaccine offers only 52.9% protection against Covid-19 (Endpoints)
• French biotech lands manufacturing deal in step toward commercialization of rare bone disease drug (Endpoints)
• Cost of a Vertex drug could worsen the global disparities in cystic fibrosis treatment, study finds (STAT)

• Africa transitioning out of pandemic phase of COVID, says WHO (Reuters)
• COVAX cuts N.Korea's COVID vaccine allotment after no deliveries accepted (Reuters)

• Generics on the way? Top drugs in danger of losing patent protection (Endpoints)
• The Quality Lowdown: Pandemic Inspection Results Trickle In As Investigators Venture Out (The Pink Sheet)
• Pfizer re-ups CytoReason collab applying AI disease models to drug development (Fierce)
• Drugs based on next-generation gene editing are moving toward the clinic faster than CRISPR 1.0 (STAT)
• Engineered TCR-T cells by Fred Hutch, San Raffaele-Intellia fend off evasive leukemia, solid tumors (Fierce)
• A small Seattle biotech wants to take on GlaxoSmithKline's emerging Shingrix blockbuster. RA Capital is on board (Endpoints)
• The 2022 top 100 biopharma investors: A look back on boom times(Endpoints)
• French biotech lands manufacturing deal in step toward commercialization of rare bone disease drug (STAT)
• Indapta snags $50M financing and signs on former Juno exec as CEO (Fierce)
• Atlas-backed neurology player Arkuda reemerges from the grindstone with a lead progranulin drug approaching the clinic (Endpoints)
• AstraZeneca picks winner in inhaled JAK 'bake-off' while sweeping Alexion drug out (Endpoints)
• Bayer-owned Askbio will shift focus toward its doggybone DNA in restructure with Touchlight (Endpoints)

• OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation (MedTech Insight)
• Philips Steps Up Ultrasound Game With Lumify 4.0 (MedTech Insight)