Recon: Akero drug meets goal in NASH study; Novartis to invest $300M in biologics operations

Regulatory NewsRegulatory News | 13 September 2022 |  By 

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)
In Focus: International
  • '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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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