Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

• GSK says tests indicate antibody drug works against Omicron (Reuters) (WSJ)
• To fight Omicron, Biden to add travel rules, make at-home COVID tests free (Reuters) (STAT)
• Special Report: US rushed contracts to COVID-19 suppliers with troubled plants (Reuters)
• AstraZeneca to Scrap Plan for US Covid Booster Study (Bloomberg)
• BD enters varicose vein treatment market with Venclose buy (Fierce)
• Democrats, Republicans in US Congress reach deal in government shutdown talks (Reuters)

• UK purchases additional 114m coronavirus vaccine doses (FT)
• UK approves another antibody treatment for Covid (BBC) (MHRA)
• Covid Omicron: Time to consider mandatory jabs, EU chief says (BBC)
• EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001) (EMA)
• WHO says surge team deployed in S.Africa's Gauteng to tackle Omicron (Reuters)
• Novavax says it could start making Omicron-specific vaccine in January (Reuters)
• Fujifilm to double size of Teesside plant that makes Covid vaccine (FT)

• Germany imposes curbs on unvaccinated, to make shots mandatory (Reuters)
• As Omicron spread looms, oral antivirals appear to be one of the best defenses — now we just need more (Endpoints)
• US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech (Pink Sheet)

• She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy (Pink Sheet)
• Janssen taps Tempus' AI and real-world data library for cancer drug discovery (Fierce)
• With only burns to show in gene therapy, Astellas inks deal with AAV specialist Dyno in push for a better capsid (Endpoints)
• FDA turns down BeyondSpring chemo complication drug, asks for another trial (MedCityNews)
• Amgen's Otezla notches win in genital psoriasis, snagging possible edge against forthcoming BMS rival (Fierce)
• Watch out, Roche: Novartis inks $1.5B deal to chase down prominent Parkinson’s target (Endpoints)
• GlaxoSmithKline, University of Oxford join forces in $40M digital deep dive into neuro (Fierce)
• Another epigenome editing startup launches from a pair of the field’s longtime leaders (Endpoints)
• Bob Nelsen woos John Maraganore to his first VC post after retiring from Alnylam (Endpoints)
• Amgen joins a growing list of drug makers cutting discounts to safety-net hospitals (STAT) (Endpoints)
• A Seattle biotech offloads lead eye drug in deal valued at $1B+ as it refocuses on emerging pipeline (Endpoints)
• Can the antibody-drug conjugate model work for NK cells? Acepodia loads up with another $109M to find out (Endpoints)
• A quiet Czech biotech bags $315M to drive its blossoming cancer pipeline through the clinic (Endpoints)

• Liquid biopsies could help screen for countless cancers. But who should get them? (STAT)
• Freenome, Siemens join forces to develop blood test for breast cancer (Fierce)
• US FDA Classifies 5 De Novo-Cleared Device Types (MedtechInsight)
• FDA Stamps Recall Of Teleflex Percutaneous Thrombolytic Device As Class I (MedtechInsight)
• IVDR amendment proposal update: moving on up to adoption (MedicalDevicesLegal)

• Bristol Myers is sued for refusing COVID-19 vaccine religious exemptions (Reuters)
• Talc Claimants Seek To Toss J&J Unit's 'Manufactured' Ch. 11 (Law360)