Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Analysis: Democrats score big wins on climate, drugs with $430 billion U.S. Senate bill (Reuters) (Endpoints) (Pink Sheet) (STAT)
- White House worked behind the scenes to push Senate toward breakthrough win (The Hill)
- Democrats dramatically narrow their ambitions for lowering insulin costs (STAT)
- Enhertu Goes Into High Gear With HER2-Low Breast Cancer Approval (Scrip) (Reuters) (MedPage Today)
- Pfizer and Myovant’s endometriosis pain drug Myfembree gets an FDA nod (Endpoints)
- FDA declines to approve expanded use of Acadia's antipsychotic drug (Reuters)
- FDA’s RTOR Program Produces Approvals About One Month Sooner Than Priority Review Goal (The Pink Sheet)
- Abortion bans complicate access to drugs for cancer, arthritis, even ulcers (Washington Post)
- There’s Just One Drug to Treat Monkeypox. Good Luck Getting It. (NYT)
- Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU (The Pink Sheet)
- UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues (The Pink Sheet)
- Sanofi increases China oncology focus with Innovent partnership (Biopharma Reporter)
- What’s in, what’s out in R&D for U.S.-India stakeholders (BioCentury)
- BioNTech expects Omicron-adapted vaccine deliveries as soon as October (Reuters)
- BioNTech Sinks as Covid Vaccine Sales and Profit Disappoint (Bloomberg)
- Pfizer Doubles Down on Sickle Cell Disease with $5.4B Global Blood Therapeutics Buy (Biospace) (Bloomberg) (Fierce) (STAT)
- Reata continues to hit FDA roadblocks with its Friedreich’s ataxia candidate, noting regulator 'concerns' (Endpoints)
- Karuna’s resurrection of Lilly drug delivers phase 3 schizophrenia success, teeing up 2023 filing (Fierce) (Endpoints) (STAT)
- Eli Lilly eyes growth outside Indiana in wake of new abortion law — and New Jersey is ready (Endpoints)
- Amgen takes BiTEs out of pipeline, dropping BCMA, PSMA assets in light of data and competition (Fierce)
- Serious liver side effects detour Amgen’s effort to expand use of its KRAS-blocking lung cancer drug (STAT) (Reuters)
- Novo Touts Diabetes R&D As Ozempic Faces Lilly Challenger (Scrip)
- At pioneering center for gene therapy, Jim Wilson presided over toxic, abusive workplace, staffers say (STAT)
- FDA’s breakthrough device designations poised for another record year (MedTech Dive)
- FDA clears AI software for spotting prostate cancer in MRI scans (Fierce)
- FDA clears Viz.ai’s algorithm to spot internal bleeds in brain scans (Fierce)
- Medtech Multinationals Up Pace Of Localization Strategies In China (MedTech Insight)
- MIT engineers develop shape-shifting artificial pancreas that brushes off the immune system’s rejection (Fierce)
- Dentsply Sirona continues internal investigation into financial reporting practices (Fierce)
- AstraZeneca, Bristol Myers Squibb and McKesson Diabetes Drug Case Dismissed (FDAnews)
- Landmark Opioid Opinion ‘Not Persuasive,’ W.VA. Panel Says (Law360)
- Teva Gets Knocked Down, But it Gets Up Again—and Petitions SCOTUS (FDA Law Blog)
- Roche Settles Claim Over NHS Over Procurement Process (Law360)
- Eli Lilly Says Indian Abortion Law Forces Hiring Out-of-State (Bloomberg)
- Healthineers Covid Test Profits Safe as Cellex Drops Patent Suit (Bloomberg)
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