Recon: EU preparing legal case against AstraZeneca; WHO, EMA set to inspect Sputnik facility in May

• FDA finds mess of sterility problems at Emergent (Focus) (NYTimes) (STAT) (Politico)
• Federal Inspectors Fear More Vaccines Were Exposed to Contamination (NYTimes)
• Worried drug pricing reform might be left behind, Democrat pushes Biden to make clear his support (STAT) (The Hill)
• A look ahead at the FDA meeting that could decide the future of 6 cancer drug approvals (BioPharmaDive)
• Oncology Accelerated Approval Withdrawals: Which Indications Need Confirmation Next? (Pink Sheet 1, 2)
• No evidence that Pfizer or Moderna vaccines are unsafe during pregnancy, a preliminary study says. (NYTimes) (NEJM)
• Lilly to seek industry-first FDA nod in autoimmune hair loss after Olumiant's second trial win (Fierce)
• Bidenworld fears many vaccine skeptics may be unreachable. They're trying anyway. (Politico)
• Federal Research: NIH Should Take Further Action to Address Foreign Influence (GAO)

• Pfizer confirms fake vaccine shots on sale in Mexico, Poland: reports (France24)
• EU preparing legal case against AstraZeneca over vaccine shortfalls (Reuters) (Politico)
• EU snubs extra 300 mln J&J, Astra shots in bet on Pfizer (Reuters)
• EU says Valneva has not met conditions for vaccine supply deal (Reuters)
• Roche looking for new place to test COVID-19 pill after cases plummet in UK (Reuters)
• How South Korea turbocharged specialty syringe production for COVID-19 vaccines (Reuters)
• WHO and EMA to inspect Sputnik V manufacturing in May – WHO (Reuters)
• WHO sets dates for reviews of Sinopharm and Sinovac COVID-19 vaccines (Reuters)
• Bluebird’s withdrawal of therapy from Germany could chill talks over gene therapy prices across Europe (STAT)

• Shoulder injuries to remain eligible for vaccine fund payouts under Biden administration (Science Mag)
• Norway to lend unused AstraZeneca vaccine doses to Sweden, Iceland (Reuters)
• Egypt to produce Russia's Sputnik V, rollout expected in Q3 (Reuters)
• Germany wants to buy up to 30 million doses of Sputnik V vaccine (Reuters)
• Syria gets 200,000 doses of AstraZeneca vaccine under COVAX scheme - U.N. officials (Reuters)
• In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mRNA facility (Endpoints)
• Fujifilm Launches New Japanese Avigan PIII Study for COVID-19 (PharmaJapan)

• Law professors call for FDA to disclose all safety and efficacy data for drugs (Endpoints)
• Why remote drug manufacturing evaluations won't really reduce FDA's backlog of inspections (Endpoints)
• Eli Lilly retakes innovation crown, while Bristol Myers rates most inventive pharma in annual study (Fierce)
• They Have Alzheimer’s. This Clinical Trial May Be a Last Hope. (NYTimes)
• AbbVie's Rinvoq rollout on track despite JAK safety concerns, but uncertainty remains: analyst (Fierce)
• Evotec strengthens its French connection, pledging to drop $120M into Toulouse plant for Covid-19 antibodies (Endpoints)
• Bristol Myers finds a home for 1st EU cell therapy site, clearing land near Amsterdam airport for easy logistics (Endpoints)
• Damn the critics, Biogen CEO Vounatsos orders full speed ahead on prepping a controversial aducazumab launch as FDA decision looms (Endpoints)
• Biogen reveals new data for MS therapies Tysabri and Vumerity (PMLive)
• Invitae sets up shop in North Carolina as part of plan to rapidly expand its genetic testing manufacturing (Endpoints)
• Vertex adds a new gene editing partner, paying Obsidian $75M for controllable CRISPR system (Endpoints)
• Early Zymergen investor Jenny Rooke reflects on 'chimeras' in biotech, what it takes to spot a $500M gem (Endpoints)
• Teva CEO Kåre Schultz sees a 35% raise despite the company's continued legal woes (Endpoints)
• Zymergen's bid to disrupt a $3T industrial manufacturing market goes viral, earning a massive $500M IPO (Endpoints)
• On the heels of $250M launch, Centessa barges ahead with an IPO to fuel its 10-in-1 Medicxi pipeline (Endpoints)
• An EU biotech looks to rewrite the ugly history of phosphatases, and it's taking $24M in funding to get off the ground (Endpoints)
• Kobayashi Kako Starts Recalling Products Subject to Approval Revocation (PharmaJapan)

• A new crop of medical devices are trying to hack the vagus nerve to treat disease (STAT)
• Moody's predicts brisk pace of medtech M&A amid earnings optimism (MedtechDive)
• FDA approves Medtronic's clot-resistant implant for stopping brain aneurysms (Fierce)
• J&J Vision sees FDA clearance for new Veritas cataract surgery system (Fierce)
• Tesseract raises $80M to pursue a new dimension of eye-based diagnostics (Fierce)
• Intuitive sees Q1 robot rebound in turnabout from start of year (MedtechDive)
• Oxford, Prenetics to take their COVID-19 rapid testing tech to other infectious diseases (Fierce)
• Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics (MedtechDive)
• Edwards withstands winter lows, grows Q1 sales on electives recovery (MedtechDive)

• Biden’s CMS pick faces a stiff Senate test (Politico)
• Five Macro Risks To Biotech Coming Out of Washington (LifeSciVC)
• Possible 'Showstopper' Ruling Looms In GSK Birth Defect Suit (Law360)
• GSK Engages In Systemic Age Discrimination, Suit Says (Law360)
• Dana-Farber Asks High Court To Ignore Cancer IP Row (Law360)
• Impax, Endo Say FTC's Win Doesn't Help Opana Buyers (Law360)
• Justices Eye Narrowing Bar On Patent Attacks, Not Ending It (Law360)