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