Recon: FDA rejects Lilly/Innovent lung cancer immunotherapy; A trio of public biotechs bring $1.5B to table after Phase 3 wins

• U.S. FDA declines to approve Lilly/Innovent lung cancer drug (Reuters) (The Hill) (Fierce)
• Pfizer grabs another breakthrough tag for RSV shot in older adults (Fierce)
• Novartis Lays A New Foundation In Prostate Cancer With Second Radioligand Launch (Scrip) (Endpoints)
• FDA Argues Very Few Accelerated Approvals Remain On Market Without Confirmation (The Pink Sheet)
• Takeda's rare disease drug's manufacturing and supply woes continue as FDA rejects supplement (Endpoints)
• Pfizer Covid Pill Targeted in Bid for Biden to Spur Drug Access (Bloomberg)
• ‘Forgotten’ Parents of Young Kids Push FDA to Clear Moderna Shot (Bloomberg)
• US FDA ‘Actively Working’ To Fill Vaccine Leadership Positions Ahead Of Next Round Of COVID Reviews (The Pink Sheet)
• NIH’s identity crisis: The pandemic and the search for a new leader leave the agency at a crossroads (STAT)
• Ex-Pfizer staffers slap back at accusations they stole trade secrets for new Eli Lilly partner (Endpoints)

• New EU Clinical Trial System Picks Up Pace (The Pink Sheet)
• Leo Pharma has applied for expanded approval for eczema treatment in EU (MedWatch)
• Uncertain Times: New Lockdowns, Ukraine Challenge Chinese Pharma (The Pink Sheet)
• China Tightens Science and Tech Ethics Review Rules (The Pink Sheet)
• Sanofi halts new spending on non-essential drugs in Russia and Belarus (Reuters)
• The Russian-Born CRO Leader Trying To Keep Clinical Trials Going In Ukraine (Scrip)
• Novo CEO condemns invasion of Ukraine – but keeps Russian factory running (Medwatch)

• BA. 2 Accounts for Majority of Global Cases, W.H.O Says (NYT) (The Hill)
• Sinovac Boosters Provide Key Protection for Older People, New Study Find (NYT)
• Singapore extends quarantine-free entry as Asia shifts to "living with COVID" (Reuters)

• Public biotechs raising funds? In this economy? A trio of companies brings $1.5B+ to battered sector after PhIII wins (Endpoints)
• Analyst: Obesity market could surpass USD 70bn by 2030 (MedWatch)
• A Bayer partner slims down, trimming R&D and enacting layoffs, to better focus on the pair's prostate cancer work (Endpoints)
• Orion staff brace for layoffs, program terminations after cancer and pain emerge as R&D stars (Fierce)
• Another Eylea rival struggles in phase 2, this time fielded by Ribomic (Fierce)
• Celsius turns up the heat with lead drug selection, $83M financing (Fierce)
• Former FDA vaccines deputy Krause heads down under as Mesoblast tries again on nearly entire pipeline (Endpoints)

• Wision A.I. secures FDA nod for polyp-spotting colonoscopy tech (Fierce)
• Lawyers Say Jackson’s Supreme Court Impact Could Be Felt On Administrative, Patent Cases (MedTech Insight)
• AstraZeneca deepens digital ties with Huma in pursuit of clinical trial apps (Fierce)

• Sun Pharmaceuticals to pay $485 million to settle claims its Ranbaxy unit caused customers to overpay for generics (STAT)
• Merck Beats Suits Tying Thighbone Fractures to Osteoporosis Drug (Bloomberg)
• Genentech Loses Patent Trial Over Sandoz’s Generic Esbriet (Bloomberg)
• United Therapeutics Loses Process-Patent Ruling in Liquidia Case (Bloomberg)
• Tearful Theranos Whistleblower Says Boies Threatened Suit (Law360)
• Congress Needs to Confirm a PTO Leader, Newly Retired Judge Says (Bloomberg)