Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- ‘Litany of false promises’: Pharma bemoans drug pricing bill as patient advocates celebrate (Fierce) (Generics Bulletin)
- Haggling With Pharma: Medicare Drug Price Negotiations Explained (Bloomberg)
- With drug pricing almost done, Congress looks to wrap up FDA user fee legislation (Endpoints)
- The GOP blocked an insulin price cap: What it means for diabetics (Washington Post)
- After addressing FDA’s concerns, Reata’s wait for ataxia drug decision extended by 3 months (Fierce) (Endpoints)
- FDA's vaccine adcomm to review first fecal transplant to treat C. difficile infections (Endpoints)
- Verona’s shares jump as COPD drug hits goal in phase 3, teeing up FDA filing (Fierce)
- FDA slaps CorMedix with a second manufacturing-related drug rejection (Fierce) (Endpoints)
- US Moves to Stretch Out Monkeypox Vaccine Supply (NYT) (Washington Post)
- Will low-dose vaccination stretch the monkeypox vaccine supply, or backfire? (STAT)
- US to buy Siga's IV drug worth $26 million to fight monkeypox outbreak (Reuters)
- US to stop supplying Lilly's mAb for Covid-19 this month as commercial market awaits (Endpoints)
- America has a maternal mortality crisis. Biden push aims to change that (Washington Post)
- EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot (Reuters)
- COVID-19 vaccines: Commission and Moderna adapt delivery schedules for late summer and winter (European Commission)
- Anger and anxiety stalk EU’s monkeypox vaccine lottery (Politico)
- Advanz bags EU rights to Polypid’s prolonged-release antibiotic (Fierce)
- Agency donates breathing devices for premature babies to Ukraine (Reuters)
- Pfizer manufacturing workers walk out after similar pay disputes at GSK, Novo Nordisk (Fierce)
- Mixed Results For China’s First Home-Grown COVID Antiviral (Scrip)
- New Graft Probes Cast Shadow Over China's Drug Pricing, Reimbursement Systems (Pink Sheet)
- GSK Ups Ante in ADC Discovery Game with $1.4B Mersana Option Deal (Biospace) (Endpoints) (Pharmalive)
- Merck is back in Alzheimer’s saddle with $1B+ Cerevance pact, years after dropping the BACE (Fierce)
- Biopharma Industry Shows Signs of Life in Ever-Changing Economic Landscape (Biospace)
- Kodiak manages to score a win for its Eylea rival — but the major test is still ahead (Endpoints)
- BeiGene and Novartis Make Late-Stage Progress against Liver Cancer (Biospace)
- AstraZeneca ADC barrels forward as Keytruda combo data make case for lung cancer use (Fierce)
- Verona, Daiichi Sankyo, AstraZeneca and Kodiak Score Big Wins in Key Diseases (Biospace)
- Aptar takes up option on Orbital high dose dry powder inhaler in pursuit of halcyon drug delivery days (Fierce)
- For the second time, Pfizer tries a warranty in response to concerns over high drug costs (STAT)
- Struggling Novavax halves its sales forecast as COVID shot launch sputters (Fierce) (Endpoints)
- Teva bullish ahead of 2-step biosimilar attack on Abbvie’s blockbuster Humira (Biopharma Reporter)
- Q&A: Astellas' retiring head of development reflects on gene therapy deaths (Endpoints)
- Why non-opioid pain drugs keep failing — and what's next for the field (Endpoints)
- Phillips In Talks With DOJ Over Breathing Machine Recalls (MedTech Insight)
- Call for EU reference laboratories sent to Member States (EC)
- The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures (Fierce)
- Hyris T-Cell Test Gains CE-IVD Mark (FDAnews)
- FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for retail sales approval (MedTech Dive)
- BD begins tender offers for up to $500M in debt to advance repayment strategy (Medtech Dive)
- Eight Indicted In Alleged Genetic Testing Fraud (MedTech Insight)
- Medtronic Settles Man’s Suit Over Alleged Pacemaker Defect (Bloomberg)
- Viatris Must Face Novo Nordisk Ozempic Patent Claims in Delaware (Bloomberg)
- Karyopharm’a Win Over Investors on Cancer Drug Data Affirmed (Bloomberg)
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