Recon: Merck to manufacture J&J COVID vaccine; Merck withdraws Keytruda for third-line SCLC

• Merck to help make Johnson & Johnson's COVID-19 vaccine: White House official (Reuters) (Politico) (WaPo)
• J&J COVID-19 vaccine shipping to US, but new deliveries hinge on regulators (Reuters 1, 2)
• US downplays possibility of sharing COVID-19 vaccines with Mexico (Reuters)
• Fauci says US must stick to two-shot strategy for Pfizer, Moderna vaccines: paper (Reuters) (WaPo)
• Novavax COVID-19 shot could be cleared for US use by May: CEO (Reuters)
• Inovio expects COVID-19 vaccine U.S. trial data by early second quarter (Reuters)
• FibroGen shares sink as FDA meeting decision suggests another delay for top drug (BioPharmaDive) (Endpoints)
• Senate to vote on $1.9 trillion coronavirus relief bill this week (The Hill)
• Drug industry pushes FDA to solve growing inspection backlog (Politico) (Pink Sheet)
• Medicare Part B: Payments and Use for Selected New, High-Cost Drugs (GAO)
• Merck withdraws Keytruda in type of lung cancer amid 'industry-wide' review by FDA (BioPharmaDive) (Fierce) (Endpoints) (Press)
• The Trump administration quietly spent billions in hospital funds on Operation Warp Speed (STAT)

• EU, under pressure over vaccine rollouts, considers switch to emergency approvals (Reuters)
• EU executive says joint vaccine strategy not unravelling (Reuters)
• Russia’s coronavirus vaccine is alluring for Eastern Europe, creating a headache for the EU (CNBC)
• UK rollout data on AstraZeneca shot should guide other countries: vaccine chief (Reuters)
• UK finds vaccines 80% effective at preventing hospitalisations in over-80s (Reuters)
• WHO panel issues strong advice against hydroxychloroquine for COVID-19 (Reuters)
• COVAX vaccine programme to deliver 237 million doses to 142 nations by end-May (Reuters)
• China aims to vaccinate 40% of population by end-July: senior adviser (Reuters)
• Pfizer requirements causing delays in COVAX deliveries: GAVI (Reuters)

• Contagious Brazil COVID-19 variant evades immunity, scientists warn (Reuters) (NYTimes)
• Covid vaccines show few side effects after millions of jabs (FT)
• Little Cerecor sees shares jump on COVID-19 readout, seeks EUA though margins of success are thin (Fierce)
• US Chamber opposes WTO waiver of vaccine intellectual property rights (Reuters)
• Comirnaty Label Updated in Japan to Ease Storage Temperature: Pfizer/BioNTech (PharmaJapan)
• Austria and Denmark plan vaccines with Israel to bolster slow EU supply (Reuters)
• Slovakia Becomes Second EU Country To OK Use Of Russian Vaccine (Pink Sheet)
• Malaysia approves Sinovac, AstraZeneca COVID-19 vaccines for use (Reuters)
• Venezuela approves use of China's Sinopharm coronavirus vaccine (Reuters)
• Vaccine exporter India says it has plenty of shots for its own people (Reuters)
• France uses only quarter of Astrazeneca vaccine doses: ministry (Reuters)
• France lifts restrictions on Oxford/AstraZeneca jab for over-65s (FT)
• Canada vaccine committee advises against use of AstraZeneca COVID-19 shots for 65 years and above (Reuters)
• South Korea says up to medical personnel to extract extra doses of COVID vaccine from vial (Reuters)
• Woman dies from brain haemorrhage in Japan days after vaccine, but link uncertain (Reuters)

• Agilent to Acquire Resolution Bioscience for up to $695M, Expanding in Precision Medicine (GEN)
• ‘An Arm and a Leg’: Revisiting Insulin: How the Medicine Got So Expensive (KHN)
• Pfizer the latest pharma to befriend Iktos for its AI drug discovery platform (Fierce)
• Oncopeptides gets FDA accelerated approval for Pepaxto (Pharmaletter)
• Prescribing Brand Name Drugs Instead Of Generic Drugs Costs Medicare $1.7 Billion A Year, Study Finds (Forbes)
• AbbVie sells biologics plant to Pharmaron, fueling the China company's cell and gene therapy ambitions (Fierce)
• Cosentyx gains EU approval for new label extension (PharmaTimes)
• NHS prescription charges set to rise in England (PharmaTimes)
• NICE backs selective internal radiation therapy for advanced liver cancer (PharmaTimes)
• MHLW Unveils List of “Stable Supply Medicines” (PharmaJapan)
• MHLW Orders Label Revisions for NSAIDs, Salbutamol, Kymriah (PharmaJapan)
• Look for Eli Lilly's Verzenio to hit $4.6B, thanks to early breast cancer win: analyst (Fierce)
• Cancer Research UK joins forces with Teon to develop new cancer drug (Pharmafile)
• Meta-analysis Finds Nonsignificant Differences Between Infliximab Biosimilars (Big Molecule Watch)
• OrbiMed, biopharma's biggest investor, closes $3.5B in three new private funds (Endpoints)
• Precision inflammation drugs? Yale spinout Artizan clinches $11M and Biohaven deal to single out bad bacteria (Endpoints)
• 'Never been more urgent:' Scynexis looks to tackle superbug crisis with late-stage readout for antifungal hopeful (Endpoints)
• A spotlight schizophrenia drug in Neurocrine's $2B Takeda deal flunks its first major test. But it's not giving up yet (Endpoints)
• Mesoblast gets a $110M lifeline from SurgCenter Development; uniQure still unsure if gene therapy spurred cancer event (Endpoints)
• AbbVie tees up a biotech buyout after sizing up their Parkinson's drug spun out of Kevan Shokat's lab (Endpoints)
• A 'love story': WuXi AppTec wraps UK-based CRO into its cell and gene therapy unit (Endpoints)
• Proposal to Refuse to Approve a New Drug Application for Sotagliflozin Oral Tablets, 200
• Milligrams and 400 Milligrams (FDA)

• Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped (FDA)
• CMS moves to stop COVID-19 testing denials, cost sharing in private plans (MedtechDive)
• Hologic further expands diagnostics reach with $159M Diagenode tuck-in buy (Fierce)
• FDA clears first surgical robot for transvaginal hysterectomies (Fierce)
• Clue expands into digital contraception with FDA clearance (mobihealthnews)

• A nascent state effort would tax drug makers for not providing clinical evidence for price hikes (STAT)
• Justices Suggest PTAB Will Survive, But With More Oversight (Law360)
• Fed. Circ. Backs $173M Bayer Patent Win On Hemophilia Drug (Law360)
• EpiPen Ruling Could Embolden Private Anti-Kickback Claims (Law360)
• Another Strike Against Failure to Report Claims (Drug & Device Law)