Recon: Sanofi, GSK delay COVID vaccine; Novartis’ Leqvio gets EU approval

• FDA advisers overwhelmingly back authorizing Pfizer COVID-19 vaccine (Reuters) (NYTimes) (Focus)
• US to approve of Pfizer COVID-19 vaccine in coming days -Azar (Reuters)
• FDA 'working rapidly' on Pfizer COVID-19 vaccine decision (Reuters)
• US trying to secure more doses of Pfizer vaccine (Reuters) (FT)
• Pfizer plans to file for full FDA approval of COVID-19 vaccine in April 2021 (Reuters)
• In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition (STAT)

• Sanofi and GSK delay COVID-19 vaccine, marking setback for global fight (Reuters) (STAT)
• EU drugs regulator endorses changes to remdesivir marketing for COVID-19 use (Reuters)
• Australia Scraps Covid-19 Vaccine That Produced HIV False Positives (NYTimes) (WSJ)
• Bahrain plans free shots, Saudi Arabia approves Pfizer jab (AP)
• Novartis gets EU approval for potential blockbuster cholesterol drug Leqvio (Reuters) (Endpoints)
• Hong Kong to get Sinovac, Pfizer/BioNTech vaccines in first quarter (Reuters)
• Emergency vaccine approval not legal option in Switzerland (Reuters)
• Advisers to Mexican health regulator to review Pfizer vaccine on Friday (Reuters)
• AstraZeneca hitches ride with Russia's Sputnik in vaccine race (Reuters)
• GSK says adjuvant volume target of one billion doses under review (Reuters)
• Interview: Emer Cooke (Nature)

• Any vaccine adverse effects up to national agencies to review – WHO (Reuters)
• Still No WTO Agreement On COVID-19 IP Waiver (Law360)
• Five severe-COVID risk genes found, suggesting drug targets (Reuters)
• Roche launches lab antigen test to support high-volume COVID-19 testing (Reuters)
• CDC official tells Congress she was told to delete email seeking to alter scientific report (The Hill)

• Experts Push for New Cancer Drug Dosing Recommendations (Undark)
• ‘Bruised’ But Not Broken: Ex-Commissioners See FDA Intact Amid Transition (Pink Sheet)
• 2020's IPO party continues with four new Nasdaq entrants, including Covillionaire Carl Hansen's AbCellera (Endpoints)
• MSD announces 240 new jobs with expansion at Dunboyne (Irish Times)
• Albireo submits rare liver disease med odevixibat to FDA and EMA (PharmaTimes)
• Despite flopping pivotal trial, Novartis' Entresto will face adcomm firing line for holy grail heart failure patients (Endpoints)
• Looking for an edge in vaccines, Thermo Fisher plots major expansions across global manufacturing sites in its portfolio (Endpoints)
• Savara shuts down another cystic fibrosis program after a PhIII flop, as it prepares to axe staff and re-center around aPAP (Endpoints)
• New biotech backed by Third Rock launches with $81 million to go after ALS, other diseases (STAT)
• Novartis radiotherapy unit snags tax abatement for $72M Lutathera plant (Fierce)
• Sanofi to resume dosing in fitusiran clinical studies in the U.S. (Press)
• Oncolytic immunotherapy biotech CG Oncology nabs $47M round for late-stage cancer push (Fierce)
• Sanofi delays hemophilia filing 18 months amid safety concerns (Fierce)
• Alunbrig scores NICE backing for ALK-positive lung cancer (PharmaTimes)
• Viatris plans across-the-board cuts that could endanger 9,000 workers, 15 plants in post-merger restructuring scheme (Endpoints)
• Global Blood Therapeutics recruits a CHOP sickle cell expert as R&D chief; Catalent plucks Janssen vet to head new clinical packaging facility (Endpoints)
• News briefing: CG Oncology nets $47M Series D for bladder cancer studies; Single-cell transcriptomic startup raises $24M launch cash (Endpoints)

• Rani Therapeutics nets $69M to transform injections into its easy-to-swallow 'robotic pill' (Fierce)
• Dexcom lays out strategy to double revenue by 2025, eyes hospitals, new markets (MedtechDive)

• Bristol Myers Squibb Announces Settlement of U.S. Patent Litigation for REVLIMID® (lenalidomide) with Cipla (Press)
• Senate squabbling sparks shutdown threat (The Hill)
• AbbVie As Both Victim And Villain Dooms Kickback Suit (Law360)