Recon: FDA advisors weigh OTC birth control pill; Gilead prevails in HIV drug patent suit

• ‘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)