Recon: FDA approves Merck’s pneumococcal jab; Boston Scientific to purchase Silk Road Medical for $1.16B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- With sweeping NIH reform on the table, GOP previews new era of research scrutiny (STAT)
- PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors (Pink Sheet)
- Flat-Lining US FDA: Failure To Invest May Have Consequences (Pink Sheet)
- CAR-T Therapies: Access Considerations May Influence US FDA's Efficacy Evaluation (Pink Sheet)
- Boston Scientific to buy Silk Road Medical in $1.16 billion deal (Reuters)
- US FDA puts Zentalis' cancer drug studies on partial hold after patient deaths (Reuters)
- US FDA approves Merck's pneumococcal vaccine for adults (Reuters)
- Amazon Pharmacy expands $5 monthly subscription to Medicare patients (Reuters)
- US FDA puts partial clinical hold on BioNTech's early-stage study of cancer drug (Reuters)
- AstraZeneca's breast cancer drug combination fails in late-stage trial (Reuters)
- Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns (Pink Sheet)
- UK Early Access Scheme 'A Success,' But Industry Wants Improvements (Pink Sheet)
- Global Governments ‘Neglecting’ Vaccine Investment Post-COVID (Pink Sheet)
- Old Painkiller, Old Concern: EMA Revisits Metamizole’s Safety (Pink Sheet)
- EU HTA Regulation: Guidance Released On Joint Clinical Assessment Scoping & Reporting (Pink Sheet)
- EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports (Pink Sheet)
- China accuses U.S. of "malign intention" to discredit its COVID vaccines (Reuters)
- A biotech’s binary bet ends badly (STAT)
- How a tweet about a gene discovered long ago led to a $190 million startup and, maybe, hope for heart disease (STAT)
- Day One enters ADC field, going after a target that once attracted AbbVie and now Genmab (Endpoints)
- As it deepens immunology bets, Sanofi inks small molecule pact with Belharra (Endpoints)
- Roche strikes neuro-focused partnership with RNA exon editing startup, worth as much as $1.8B (Endpoints) (Reuters)
- A new obesity biotech; UroGen aims to raise $107M (Endpoints)
- Hikma to take over several assets from Xellia, including a US manufacturing site (Endpoints)
- Marea Therapeutics launches with $190M, seeing a 'fixable problem' in a neglected cardiometabolic target (Endpoints)
- Former medical device CEO who sold fake plastic parts sentenced to 6 years in prison (STAT)
- Freespira bets on slow and steady, amid spectacular digital health collapses (STAT)
- To feed an AI that designs new enzymes, Basecamp hunts rare proteins at the world’s end (STAT)
- How two academic chemists turned San Diego startup Iambic into an AI force (Endpoints)
- Philip Morris suspends nationwide sales on Zyn.com after D.C. subpoena (Reuters)
- Why the FDA will have a hard time properly regulating cannabis (STAT)
- Teva in talks to settle US lawsuit alleging MS drug kickbacks (Reuters)
- This federal rule didn’t stop coercive sterilization — but it blocked contraceptive access. Can it be fixed? (STAT)
- Drugmaker Apotex accuses Amarin of Vascepa monopoly in US lawsuit (Reuters)
- US Surgeon General calls for social media warning labels to protect adolescents (Reuters)
- OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers) (FDA Law Blog)
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