Recon: Indivior to acquire Opiant for $145M; Roche Alzheimer’s drug fails in Phase 3 studies

ReconRecon | 14 November 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Moderna's Omicron shots shows better immune response than original COVID vaccine (Reuters) (STAT)
  • Satsuma Pharma's migraine drug fails late-stage study, shares crash (Reuters)
  • U.S. FDA approves AstraZeneca's lung cancer drugs (Reuters)
  • Narcan Owner Opiant to Be Acquired by Indivior for $145 Million (WSJ)
  • After blazing trails in RNA-targeted drugs, Ionis jumps into gene editing (STAT) (Endpoints)
  • Biogen’s new CEO, clear-eyed about company’s challenges, prepares to take the reins (STAT)
In Focus: International
  • Less and late: UK gives $1 bln to global disease fight (Reuters)
  • Roche's Alzheimer's drug fails to meet goal in long awaited trial (Reuters) (STAT)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022 (EMA)
  • Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster (Fierce) (EMA)
  • Germany's BioNTech says to set up mRNA vaccine facility in Singapore (Reuters)
  • Uganda confirms Ebola case in country's east as outbreak expands (Reuters)
  • Spanish competition watchdog fines drugmaker Leadiant 10.3 mln euros (Reuters)
  • China's Silk Road Fund to invest in Indonesian pharma firms (Reuters)
  • Bristol Myers Squibb warns UK medicines levy threatens investment (FT)
  • WHO releases first data on global vaccine market since COVID-19 (WHO)
Pharma & Biotech
  • Myocarditis after Covid vaccination: Research on possible long-term risks underway (NBC)
  • GSK pulls another cancer indication for Zejula at FDA's request (Endpoints)
  • Eli Lilly pulls millions in Twitter advertising after fake account debacle — report (Endpoints)
  • US FDA Ready To Move Forward On Developing Quality Management Maturity Rating System (Pink Sheet)
  • NDAs, BLAs To Start Getting KASA Quality Risk Assessments After Successful Pilot With ANDAs (Pink Sheet)
  • Roivant cuts 12% of workforce to save cash, a blow to the larger divide-and-conquer 'vant' strategy (Fierce)
  • With new update in hand, Intellia CEO now claims one-time HAE gene editing treatment 'may be a functional cure (Endpoints)
  • Swiss health office and pharma firm at odds over flu spray (SwissInfo)
  • After CRL, drug developer duo resubmits its experimental drug to the FDA, looking to compete with Fabrazyme (Endpoints)
  • Many Female Arthritis Drug Users Face Restrictions After Dobbs (Bloomberg Law)
  • Aiming at mainstream markets, radiopharmaceutical partners engineer $260M cash deal (Endpoints)
  • Seagen's highest selling drug snags a label expansion for pediatric cancer patients (Endpoints)
  • Norwegian biotech concludes 'strategic' review with a reverse merger (Endpoints)
  • Green light shows promise in addressing oximetry racial bias: study (MedtechDive)
  • Ophthalmic Dispensers Recommended Class I Designation By FDA Panel (MedtechInsight)
  • COVID-19 Cases Show Device Preemption Prevails, Attorney Says (MedtechInsight)
  • Matching Capacity To Demand: How EU Notified Bodies Are Managing (MedtechInsight)
  • Tandem pump, paired with Dexcom CGM, boosts blood glucose control in Type 2 diabetics (MedtechDive)
  • Mayo Clinic creates product to test AI models for bias and inaccuracy (MedtechDive)
Government, Regulatory & Legal
  • Viatris executive is charged with insider trading scheme involving a friend and former colleague (STAT)
  • Ahead of Elizabeth Holmes’ sentencing this week, prosecutors ask for 15 years hard time (Fierce)
  • Pharma-backed charity sues HHS to help pay for seniors' pricey cancer drugs (Endpoints)
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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