Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

• Novavax says efficacy preserved in participants receiving influenza, COVID-19 vaccines (Reuters)
• Trump’s FDA commissioner takes job at Moderna backer (Washington Post) (Endpoints)
• Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda (Bloomberg) (Law360)
• Sage's depression drug study results show improvement in symptoms (Reuters) (STAT)
• New Alzheimer's drug could be 'devastating' for Medicare (Politico)
• Biogen gene therapy deal has yet to bear fruit (BioPharmaDive) (Endpoints) (Press)
• FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’ (Endpoints)
• Scientists CRISPR patients’ own immune cells in bid to shrink hard-to-treat GI tumors (STAT)
• Mississippi becomes the first state to jointly sue drug makers and PBMs over the cost of insulin (STAT) (Endpoints)

• Governments need ‘portfolio of vaccines’ to beat Covid, says EMA head (FT)
• Japan should have scrapped domestic trials to speed COVID shots - vaccine chief (Reuters)
• Novavax's COVID-19 vaccine to be made in India soon - govt official (Reuters)
• Astra antibody cocktail fails to prevent COVID-19 symptoms in large trial (Reuters) (FT)
• Regulator begins probe into Pfizer’s anti-nicotine therapy for impurities (Korea Biomedical Review)

• More evidence suggests Covid was in U.S. by Christmas 2019 (NBC) (NYTimes)
• Many Post-Covid Patients Are Experiencing New Medical Problems, Study Finds (NYTimes)
• Extra Covid vaccine may help protect transplant patients (STAT)
• Brazil's Bolsonaro asks Pfizer to speed up COVID vaccine delivery (Reuters)
• Pakistan allows AstraZeneca shot for under 40s to help its expatriates (Reuters)
• Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study (MedtechDive)

• FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’ (Endpoints)
• ‘You have to get up on the podium’: Incoming BIO chair Paul Hastings on diversity, drug pricing and working with the FDA (Endpoints)
• Bayer flushes money into the Nordics with $303M down payment on new Finnish plant, expansion (Endpoints)
• Slashing 186 jobs, Novartis hands off U.S. sales, marketing duties for migraine med Aimovig to Amgen (Fierce)
• Eli Lilly pins injectable migraine med Emgality against Biohaven's oral rival Nurtec ODT in head-to-head study (Fierce)
• FDA pushes back Ascendis' PDUFA for long-acting hormone therapy; Debiopharm takes home a win in mid-stage test for ADC (Endpoints)
• Why two scientific powerhouses are teaming up to tackle rare cancers long overlooked in research (STAT)
• VectorY raises $38M to develop Alzheimer's, ALS gene therapies (Fierce)
• The Next US FDA Center Of Excellence? Pazdur Thinks It Should Be (Surprise!) Biostatistics (Pink Sheet)
• CRISPR Therapeutics takes a swing at ALS gene editing in discovery deal with AAV upstart Capsida (Endpoints)
• Imbruvica/Venclyxto tops Gazyva plus chemo in first-line CLL/SLL (PharmaTimes)
• J&J’s Darzalex shows ‘significant’ survival benefit in newly diagnosed multiple myeloma (PMLive)
• Terns Pharmaceuticals touts safety data from an ex-Eli Lilly candidate in the hunt for NASH treatment (Endpoints)
• Just shy of its 1-year anniversary, radiopharmaceuticals platform play RayzeBio bags another megaround (Endpoints)
• Going after the phenomenon of 'regRNA,' Rick Young's Camp4 secures a launch round to push two programs forward (Endpoints)
• Swiss-based upstart marches toward the clinic with a unique approach to fibrosis treatment (Endpoints)
• SoftBank, Cormorant lead hefty $210M injection for Umoja's three-in-one cancer immunotherapy play (Endpoints)
• Exscientia spends SoftBank's cash in bid to edge out AI rivals (Endpoints)
• Recall report: Another drugmaker is pulling its version of metformin off shelves after a carcinogen scare (Endpoints)
• Other OMUFA Fee-Related Questions (FDA)

• With new data, Veracyte aims to expand prostate cancer test reach following Decipher acquisition (Fierce)
• Twist Bioscience, Regeneron pitch global sequencing test to bring new diversity to large DNA studies (Fierce)
• Novo's investment arm gains toehold in diagnostics with £400M deal for testing supplier BBI (Fierce)
• EU Coordinates Market Surveillance For The First Time: Pilot Being Launched (MedtechInsight)
• Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices (MedtechInsight)
• FDA advisory panel to review TransMedics' liver preservation device (MedtechDive)
• Avita’s ReCell Wins FDA Approval For Pediatric Burn Patients (MedtechInsight)
• One Drop poaches Sanofi’s head of diabetes innovation to bring CGM biosensor to market (Fierce)
• Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport (FDA)
• The TGA response to ACCC safety and information standards (TGA)

• W.Va. State Opioid Claims Will Be Heard By A Jury (Law360)
• CVS Overcharged Insured Drug Buyers $123.7M, Jury Told (Law360)
• Glenmark, Teva In No Rush For January 2022 Criminal Trial (Law360)
• Insulin Makers Blast Patients' 3rd Bid For RICO Claims (Law360)
• Mallinckrodt Says Ch. 11 Disclosures Have Enough Info (Law360)
• Purdue Hits Back At Creditor's Motion For Ch. 11 Examiner (Law360)