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

• 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)