Recon: FDA authorizes COVID vaccine boosters for the immunocompromised; Jazz nabs sleep disorder indication for GHB drug Xywav

• FDA authorizes COVID-19 boosters for the immunocompromised (Reuters) (Endpoints) (STAT) (FDA)
• CDC advisers set to sanction third Covid shots for immunocompromised (Politico)
• Pfizer, Moderna seen reaping billions from COVID-19 vaccine booster market (Reuters)
• As Virus Cases Surge, Biden Administration Encourages More Use of Antibody Drugs (NYTimes)
• FDA approves expanded use of Jazz's sleep disorder drug (Politico) (Endpoints) (NYTimes) (FDA)
• U.S. FDA has not seen possible side-effects of COVID shots being studied in EU (Reuters)
• Ellis Unger, an outspoken FDA veteran, retires (STAT) (Endpoints)
• Purdue Pharma director grilled on proposed opioid settlement (AP)
• Ipsen withdraws NDA for rare bone disease treatment less than 3 months after winning priority review (Endpoints)

• UK watchdog says to investigate COVID-19 testing firms (Reuters)
• India set for huge boost in COVID vaccine supplies - ruling party chief (Reuters)
• India's Bharat Biotech's nasal COVID-19 vaccine advances into next stage of trials (Reuters)
• Israel expands COVID vaccine booster campaign to over 50s, health workers (Reuters)
• Vectura board says it will unanimously back a Philip Morris takeover (Endpoints)
• As Bluebird backpedals from Europe, small gene and cell therapy players face tough hurdles (STAT)

•  WHO calls on governments to cooperate to accelerate studies into origins of COVID-19 (Reuters)
• WHO seeks to take political heat out of virus origins debate (Reuters)
• Novavax, Fujifilm plow ahead on Covid-19 vaccine production despite OWS setback (Endpoints)
• Eli Lilly joins the growing ranks of Big Pharma players mandating vaccinations for most staffers (Endpoints)

• New drug application filings with FDA to cost more than $3M for first time ever in 2022 (Endpoints)
• Anti-aging foundation’s CEO left amid an investigation of co-founder Aubrey de Grey (STAT)
• Vifor blasts FDA's 'reckless' renaming of 4 drugs under the same molecule moniker (Endpoints)
• Mustang inks a deal for in vivo CAR-T tech from the Mayo Clinic; How a spilled cup of tea landed one biotech $11.7 million (Endpoints)
• FDA approves belzutifan for cancers associated with von Hippel-Lindau disease (FDA)
• The Code is Cracked: Interchangeable Biologics are Here (FDA Law Blog)
• GDUFA III Talks In Final Stages, Agreement Nearly Complete (Pink Sheet)
• What’s next for an immuno-oncology powerhouse? (Nature)
• NICE approval for Lilly's Verzenios is “fantastic news for thousands of women” (PMLive)
• Scottish Funding Wins for Kite’s CAR-T Tecartus & Five Other Products (Pink Sheet)
• J&J, Amgen and Roche face growing biosimilar competition that is driving down prices: report (Fierce)
• Viatris in talks with West Virginia University on plan that could keep idled Morgantown factory afloat (Fierce)
  Rentschler Breaks Ground on New U.S. Production Site (GEN)
• Manufacturing issues hold back distribution of overdose injection; San Diego biotech triples footprint (Endpoints)
• Longeveron's cell therapy flops early walk test study, but investors cheer flimsy supporting data (Endpoints)
• Hisamitsu Ordered to Suspend Biz over Salonpas OTC Data Tampering (PharmaJapan)

•  Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart (FDA)
• Baxter's preprogrammed infusion pump software recall lands FDA Class I label (Fierce) (FDA)
• US now a priority market for most developers of novel devices, FDA survey finds (MedtechDive)
• FDA Hits Snooze On Remanufacturing Draft Guidance, Cybersecurity Discussion Paper (MedtechInsight)
• Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls (MedtechInsight)
• EU Prioritizes Risk Management And Quality System Standards Now Legal Basis In Place (MedtechInsight)

•  Claims Filed Too Late In Cook Medical Vein Filter Suit (Law360)
• Purdue's Ch. 11 Trial Opens With Attacks On Sackler Releases (Law360)
• Mylan Latest To Urge Justices To End PTAB's Fintiv Rule (Law360)
• Hemp Group Says FDA Inaction On CBD Harms Consumers (Law360)
• GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021) (Patent Docs)