Recon: Merck says COVID antiviral cut risk of hospitalization, death in Phase 3 trial; Appeals court rules FDA wrongly approved Jacobus' LEMS drug

• Merck's COVID-19 pill cuts risk of death, hospitalization by 50% in study (Reuters) (STAT)
• Appeals court rules FDA ‘arbitrarily and capriciously’ approved a rare disease drug (STAT) (Endpoints)
• Democrats struggle to reach deal in Congress on Biden's agenda (Reuters)
• Senate committee considers a carveout for small biotech cos in drug pricing reforms (STAT)
• US House panel approves fourth bill aimed at drug prices (Reuters)
• Biden admin releases new protections shielding patients from 'surprise' bills (Politico) (STAT)
• California judge questions counties' opioid case against drugmakers at trial's end (Reuters)
• Pharmacy chains face first trial in US opioid litigation, judge urges settlement (Reuters)
• Siemens gets FDA clearance for 'major' improvement to CT imaging (MedtechDive) (FDA)
• AdvaMed defends J&J in $344M row with California court over mesh marketing (MedtechDive)

• Britain in talks on new drugs but no specific news on Merck's COVID-19 pill (Reuters)
• India's Serum Institute to boost vaccine exports gradually, report says (Reuters)
• Japan's Takeda says 'human error' caused contamination of Moderna vaccines (Reuters)
• EU finds J&J COVID shot possibly linked to another rare clotting condition (Reuters) (EMA)
• EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines Share (EMA)
• In a first, COVAX to send COVID shots only to least covered nations (Reuters)
• EMA welcomes new Head of International Affairs (EMA)

• Nobel Medicine Prize for COVID-19 vaccine? It may be too soon (Reuters)
• Brazil's Biomm signs deals to distribute Cansino COVID-19 vaccine (Reuters)
• Israel reports very few myocarditis cases after Pfizer boosters (Reuters)
• Malaysia approves Sinovac's COVID-19 vaccine for ages 12 to 17 (Reuters)

• POLITICO-Harvard poll: Drug price negotiation is Americans' top priority (Politico)
• New House bill aims to shore up US API production in response to pandemic shortages (Endpoints)
• House votes to create office for medical intelligence to get earlier pandemic warnings (NBC)
• Research Firm for Pfizer, Novartis Morphs Into Low-Cost Rival (Bloomberg)
• Emergent lands another big money contract from BARDA for anthrax (Endpoints)
• An FDA mistake signals likely approval for Vivek Ramaswamy’s first therapy for children born without a thymus (Endpoints)
• United Therapeutics transitions to public benefit corporation more than 20+ years after IPO (Endpoints)
• Omeros stock craters as FDA cites deficiencies in application for HSCT-TMA drug (Endpoints)
• EU Wants Pharma To Offer ‘Ever-Warm’ Vaccine & Drug Production Capacity (Pink Sheet)
• EMA Moves To Boost Use Of Alternatives To Animal Testing (Pink Sheet)
• Closing out a quiet week on Wall Street, a new SPAC prices its public debut and begins the search for a biotech partner (Endpoints)
• Avoro Capital, the deal killer behind the Seagen-Immunomedics blowup, has turned its eyes on Merck's Acceleron buyout (Endpoints)
• The cash won't stop for Exscientia as it makes a $300M+ Nasdaq debut (Endpoints)
• Recall report: Eli Lilly pulls diabetes emergency kit after manufacturing mishap (Endpoints)
• Cytiva pledges $52.5M into South Korean operations as it expands global plans (Endpoints)
• Eli Lilly issues response to Form 483 at Indianapolis plant (Endpoints)
• Fresh off a big pandemic year, Thermo Fisher announces more growth at its Midwest hub (Endpoints)
• Bristol Myers reports shortage of chemo drug abraxane; Sartorius more than doubles capacity with Michigan expansion (Endpoints)

• A new surgical robot is smaller, nimbler, and cheaper, its maker claims. But will it be better for patients? (STAT)
• SpinaFX taps Medtronic, Zimmer Biomet alum as CEO of image-guided pain treatment startup (Fierce)
• Ransomware attacks put availability of medical devices at risk: FDA cyber chief (MedtechDive)
• Activ Surgical augments VC funding with $45M for AR-based software (Fierce)
• Blood storage tech developer Hemanext adds $15M to VC stores as it preps for FDA submission (Fierce)

• Texas Court Puts Gilead Medicaid Fraud Suit On Ice (Law360)
• PhRMA sues Arkansas over law requiring companies to offer products to 340B contract pharmacies (Fierce)
• Cherokee Want Pharmacies In State Court After Opioid Deal (Law360)