Recon: FDA advisors weigh OTC birth control pill; Gilead prevails in HIV drug patent suit
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- ‘Hard to catch up’: FDA commissioner on regulating new digital health tools (STAT) (MedtechDive)
- FDA weighing 1st over-the-counter birth control pill (Reuters) (Endpoints)
- Novavax forecasts higher-than-expected revenue; shares surge (Reuters) (Endpoints)
- Gilead Sciences prevails in US government lawsuit over HIV drug patents (Reuters) (STAT)
- Breast cancer screening should begin at 40, not 50, federal health panel recommends (STAT)
- What to know about a pivotal FDA hearing on Sarepta’s gene therapy for Duchenne (STAT)
- EQRx abandons business plan around drug pricing, cuts jobs and programs (STAT)
- Hearing Aids Are Changing. Their Users Are, Too. (NYTimes)
- Global push to tackle maternal and newborn deaths has stalled, WHO report finds (Reuters)
- Philips shareholders deal snub to board over 2022 turmoil (Reuters)
- Philips will continue to deliver hospital equipment to Russia, CEO says (Reuters)
- Roche hands Chinese biotech $70M for HER2 drug that can go to the brain (Endpoints)
- Sandoz to leave Korean market: source (Korea Biomedical Review)
- Will the EU still have Big Pharma’s back abroad? (FT)
- EU Parliament OKs Law Ending Validity Of Centralized Drug Approvals In Northern Ireland (Pink Sheet)
- Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU (MHRA)
- Moderna COVID-19 vaccine authorised for infants and children aged 6 months to 5 years (MHRA)
- Access to New Alzheimer’s Drugs Might Depend on Where You Live (WSJ)
- Drugmakers set strategy for legal fight against US pricing regulation (Reuters)
- After weight loss, Alzheimer's may be next frontier for drugs like Ozempic (Reuters)
- UK biotech start-up raises $130mn to solve capacity bottleneck (FT)
- Tarsus issues 'call to action' months before FDA decision on eye mite treatment (Endpoints)
- As Zynlonta sales disappoint, ADC Therapeutics cuts staff and preclinical programs (Endpoints)
- EU Proposal Seeks To Address Borderline Product Classification ‘As Early As Possible’ (Pink Sheet)
- Amgen enlists TCR startup TScan to work on Crohn's in deal potentially worth $500M+ (Endpoints)
- BMS, after last year's West Coast purge, lays off 48 in New Jersey (Fierce)
- Takeda laying off more than 180 workers in Massachusetts (Endpoints)
- FDA lifts partial hold on Salarius' Ewing sarcoma drug trial (Endpoints)
- Gilead's M&A streak carries on with buyout of private PARP1, autoimmune biotech (Endpoints)
- Baxter CFO Jay Saccaro to depart (Reuters)
- Baxter, GE HealthCare, Philips are at risk from changes in hospital spending: Moody’s (MedtechDive)
- Samsung gets FDA clearance for irregular heart notification feature, catching up with Apple and Fitbit (MedtechDive)
- At Musk’s brain-chip startup, animal-testing panel is rife with potential conflicts (Reuters)
- Fresenius Medical profit drops less than feared, labour shortages ease (Reuters)
- PerkinElmer life science and diagnostics spinoff reveals new name and brand identity (Endpoints)
- Thermo Fisher, Pfizer team up on global access to cancer DNA testing (Fierce)
- Siemens Healthineers, GE HealthCare Race To Develop Next-Gen AI Solutions For Personalized Care (MedtechInsight)
- Quidel Subsidiary Lands First De Novo Clearance For COVID-19 Serology Tests (MedtechInsight)
- Abortion providers sue FDA in a Virginia federal court over mifepristone restrictions (Endpoints)
- Abortion pill case to be heard by conservative, anti-abortion panel (Reuters)
- Q&A: Sen. Sanders on insulin costs and his committee’s generic drug kerfuffle (STAT)
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