Recon: FDA rejects Shin Nippon’s nasal migraine drug over manufacturing issues; GAO to review FDA’s oversight of device recalls
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Biden changes will force health insurers to speed up and get more specific if they want to deny care (STAT)
- Copay coupons for some drugs must count toward deductibles, after Biden court move (STAT)
- More patients are getting their meds online. Big Pharma wants in on the action (STAT)
- US FDA declines to approve Shin Nippon Biomedical's migraine drug (Reuters) (Endpoints)
- Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls (ProPublica) (MedTech Dive)
- FDA authorizes record number of new devices in 2023 (MedTech Dive)
- Ex-Pfizer employee convicted of insider trading on COVID drug trial (Reuters)
- Taiwan-based CDMO Bora Pharma to pay up to $210M for Upsher-Smith to expand into the US (Endpoints)
- Bayer to make significant cuts, rolls out new model at 'expense of many managerial employees' (Endpoints)
- Regulatory tracker: Roche's subcutaneous version of Tecentriq picks up EU approval (Fierce Pharma)
- AstraZeneca to drop $26.5M in China for new production line for diabetes drugs: report (Fierce Pharma)
- Looking past COPD, Regeneron CSO George Yancopoulos says Dupixent's 'next big thing' is reversing allergies (Endpoints)
- The XBI comedown after JPM (STAT)
- BridgeBio raises up to $1.2B, a month after submitting cardio drug to FDA (Endpoints)
- Lutetium, actinium or lead: Can isotope type offer an edge in radiotherapy? (Endpoints)
- Updated: Novartis axes PhIII peanut allergy trial, expects to test 'optimized dosing' in new trial later this year (Endpoints)
- Viridian’s $150M offering; Surrozen scraps IBD drug candidate; Assembly ends deal with Indiana University (Endpoints)
- CG Oncology aims for $181M listing in first biotech IPO of 2024 (Endpoints)
- Investment firm Mirae launches its US biotech VC fund with $50M (Endpoints)
- After 17-year courtship, Sun and Taro finally agree on $348M buyout (Fierce Pharma)
- Lundbeck launches ‘Say Yep’ for new Vyepti multi-media migraine campaign (Fierce Pharma)
- Jaguar Gene Therapy investors carve out manufacturing unit as a separate company (Fierce Pharma)
- Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith (Fierce Pharma)
- Lonza plots more than 200 layoffs at clinical manufacturing site in California (Fierce Pharma)
- Apple Watch pulse oximeter feature removed to comply with ban (STAT)
- FDA clears AI skin cancer detector for primary care doctors to use (STAT)
- A new, non-invasive test could help predict the quality of embryo used for IVF (STAT)
- At health care’s biggest investor conference, AI’s high hopes collided with skepticism (STAT)
- Nuvasive’s former CEO joins 3M spinoff (MedTech Dive)
- FDA warns of shoulder implant risks after Exactech declines to start voluntary recall (MedTech Dive)
- How digital therapeutics companies are improvising when insurance coverage isn’t guaranteed (STAT)
- A new HHS rule takes a far too narrow approach to health care data interoperability (STAT)
- Congress’ negotiations over doc pay, health centers fell apart ahead of spending extension (STAT)
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