Recon: Akero drug meets goal in NASH study; Novartis to invest $300M in biologics operations
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Deal or no deal: User fee reauthorization edition (Politico)
- Sony announces development of its first over-the-counter hearing aid for the US (The Verge)
- Moonshot refresh: Biden calls to cut cancer death rate by at least 50% in 25 years (Endpoints)
- Biden looks to beef up US biomanufacturing amid pressure from China (Fierce)
- Exclusive: Medical journals broaden inquiry into potential heart research misconduct (Reuters)
- Akero's drug meets main goal in NASH trial, shares surge 120% (Reuters) (STAT)
- FDA schedules meeting on OTC birth control pill application (The Hill) (Endpoints)
- AstraZeneca beats U.S. shareholder lawsuit over COVID vaccine disclosures (Reuters)
- With a promising new plan to pay for pricey cures, two states set out to eliminate hepatitis C. But cost hasn’t been the biggest problem (STAT)
- 'Challenge' to maintain world's focus on global health after COVID-19: Bill Gates (Reuters)
- Novartis plots $300M investment to grow its biologics manufacturing and development operations (Fierce)
- EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble For Manufacturers (MedtechInsight)
- Upcoming market catalysts in Q4 2022 (Nature)
- Bluebird CFO resigns ahead of gene therapy launch (BioPharmaDive)
- Implementing 'Right-to-Try': FDA signals likelihood of only minimal manufacturer participation (Endpoints)
- BioMarin says PhIII gene therapy study participant's cancer is unrelated to therapy (Endpoints) (BioPharmaDive)
- RWE’s Biggest Role In US FDA Approvals: External Controls For Breakthrough Rare Disease Therapies (Pink Sheet)
- Depression And COVID-19 Vaccines: US FDA Notes ‘Imbalance’ In Novavax Trial For Adolescents (Pink Sheet)
- Glaukos beats path to FDA after eye implant trials hit goals (Fierce)
- FDA accepts Otsuka, Lundbeck filing for long-acting schizophrenia drug, teeing up April decision date (Fierce)
- Undeterred by FDA warning, desperate Clovis seeks Rubraca nod in front-line ovarian cancer (Fierce)
- Eyeing accelerated approval for Duchenne gene therapy, Sarepta hopes to bring in $1B in bid for profitability (Endpoints)
- ObsEva will cut staff by 70% after FDA setback for uterine fibroids candidate linzagolix (Fierce)
- Acelyrin tops its $250M crossover with new $300M cash raise from blue-chip syndicate (Endpoints)
- Catheter Precision agrees to reverse merger, securing cash to target cardiac electrophysiology market (MedtechDive)
- Medtronic signs development deal with surgical robot-maker Titan Medical (MedtechDive)
- Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test (MedtechDive)
- Siemens Healthineers' Corindus surgical robot clears brain aneurysm study (Fierce)
- Endo Seeks Injunction To Pause Government Opioid Suits (Law360)
- Korean Co. Can't Be First To Invent CRISPR, PTAB Told (Law360)
- Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems (MedtechDive)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
