Recon: Lilly seeks revocation of bamlanivimab EUA; J&J asked other COVID vaccine makers to join clot probe

• Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab (Reuters) (Endpoints) (Press)
• J&J Privately Asked Rival Covid-19 Vaccine Makers to Probe Clotting Risks (WSJ) (Reuters)
• US advisory committee to meet next week to discuss J&J COVID-19 vaccine (Reuters) (Endpoints) (The Hill)
• Biden administration investing $1.7B to better track Covid-19 variants (Politico)
• States Struggle With Vaccine Pause as Federal Officials Reassure Public (NYTimes)
• Drug companies to face first opioid trial following pandemic delays (Reuters)
• FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer (FDA)
• In highly unusual move, Pacira sues medical journal for libel over its non-opioid painkiller (Endpoints) (STAT)

• No decision made yet on future contracts with AZ, J&J, French minister says (Reuters)
• Countries seek more Moderna, Pfizer/BioNTech COVID-19 shots as concerns mount over rival vaccines (Reuters)
• China Plans to Approve First Foreign Covid-19 Vaccine by July (WSJ) (Reuters)
• China’s Sinovac COVID-19 vaccine 67% effective in preventing symptomatic infection - Chile govt report (Reuters)
• Russia’s Sputnik vaccine injects divisions into EU (Politico)
• Alexion and NICE agree confidential discount for Ultomiris use on the NHS (PMLive)

• CureVac hopes to win regulatory approval for its Covid vaccine by June (FT)
• It’s COVID-19 ‘Clean-Up Time’: FDA, Health Canada Hint At What’s Next In Enforcement (MedtechInsight)
• WTO head urges movement on controversial Covid-19 vaccine proposal, but objections remain (STAT)
• Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems (NYTimes)
• Moderna says vaccines to Canada to be delayed due to Europe shortfall (Reuters)
• Moderna sees shortfall in Britain COVID vaccine shipments, EU deliveries on track (Reuters)
• ‘Slow’ UK response to AstraZeneca side-effects alarms experts (FT)

• FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar (KHN)
• TG Therapeutics prepares to approach regulators with MS drug; Investors bet $93M on a life sciences tools company (Endpoints)
• Amgen Successfully Completes Acquisition Of Five Prime Therapeutics (Press)
• AstraZeneca-Alexion merger slides through FTC review after supposed M&A crackdown poses no barriers (Endpoints)
• Novavax CFO Greg Covino makes a quick exit as leadership carousel keeps turning; Kite execs fly away to a cell therapy upstart teaming up with Lyell (Endpoints)
• AI drug prospector Recursion bumps IPO up (again) to $374M (Fierce)
• Industry ICH Proposal Would Limit International Regulatory Oversight Of Manufacturing Models (Pink Sheet)
• CellTrans’ Donislecel Gets US FDA Panel Nod For Small Group Of Type 1 Diabetics (Pink Sheet)
• Revisiting Accelerated Approval: A Provocative Rebate Proposal (Pink Sheet)
• Oncology Clinical Trial Eligibility Expansion A Focus For US FDA; Sponsors Overcoming Initial Hesitation (Pink Sheet)
• Looking to cement its lead in packed MS market, Roche's Ocrevus uncorks new data in early-stage patients (Endpoints) (Press)
• Novartis’ MS therapy Kesimpta reduces risk of disability progression regardless of relapses (PMLive)
• Abzena picks North Carolina as the home for its 6th manufacturing site, plans to add 325 jobs in Sanford (Endpoints)
• Avrobio is using 'pods' to create gene therapies, and it believes the approach could change the game altogether (Endpoitns)
• Eli Lilly-partnered biotech taps star investigator Alan List as CMO — a year after he resigned from Moffitt over China scandal (Endpoints)
• Osman Kibar lays down his hand at Samumed, stepping away from CEO role as his once-heralded anti-aging biotech rebrands (Endpoints)
• In one of their first ever acquisitions, Relay bets $85M cash on a new AI-based screening approach (Endpoints)

• EU MDR delay has not made new rules easier to stomach: exec poll (MedtechDive)
• Surgical Robotics Company Vicarious Surgical To Merge With D8 SPAC In $1.1Bn Deal (MedtechInsight) (MedtechDive)
• Siemens Healthineers closes $16.4B Varian deal while mulling the sale of its ultrasound division (Fierce)
• Activ Surgical receives FDA clearance for surgical visualization tool (mobihealthnews)
• Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports (FDA)

• Roche Challenges $171M Patent Judgment At Federal Circuit (Law360)
• IP Forecast: Ferring, Lupin To Face Off In Clenpiq Patent Trial (Law360)
• Amgen Tells Full Fed. Circ. Antibody IP Ax Dooms Biologics (Law360)
• Genentech and Centus Notify Court of Settlement of Bevacizumab Litigation (Big molecule watch)