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August 31, 2023
by Jason Scott

Recon: Emergent’s OTC opioid overdose drug Narcan to hit the shelves next week; J&J slashes price of its oral TB pill in developing countries

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Opioid overdose antidote Narcan will be widely available over the counter next week (NBC News)
  • A big insurer decides to cover naloxone for overdose; will others follow? (STAT)
  • US senators push drugmakers for details on low-cost insulin programs (Reuters)
  • Insulin Makers Facing Price Talks Appear Poised to File Lawsuits (Bloomberg Law)
  • Republican governors call on Congress to take more action on US drug shortages (Fierce Pharma)
  • AmerisourceBergen is no more as it drops its 2-decade-old merger name to become Cencora (Fierce Pharma)
  • US FDA warns 3 baby formula makers to correct manufacturing process controls (Reuters) (FDA)
In Focus: International
  • Europe to face shortage of Lilly's diabetes drug through September (Reuters)
  • J&J cuts the price of its lifesaving TB pill by more than half for many low- and middle-income countries (STAT)
  • Pharma Firm, Labs Share Tech For Covid Research Equity: WHO (Agence-France Press)
  • Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5 (EMA)
  • China's CanSino seeks more vaccine contracts after AstraZenca deal (Reuters)
  • Otsuka to acquire Mindset Pharma (Endpoints)
  • UK regulators name 3 approved bodies to ease device certification bottleneck (MedTech Dive)
  • Pharma keeps pandemic halo in eyes of UK public, but pricing is a problem (Fierce Pharma)
  • India invites bids for privatisation of Indian Medicines Pharmaceutical (Reuters)
Pharma & Biotech
  • Sage Therapeutics to cut about 188 jobs after depression drug setback (Reuters)
  • Sage remains tight-lipped on postpartum launch plans in wake of restructuring (Endpoints)
  • Pot firms surge as US move to ease curbs sparks hopes of legalization (Reuters)
  • One dose of psilocybin may have lasting effects on major depression, study finds (STAT)
  • Drug firms test medicines to halt Alzheimer’s before symptoms appear (STAT)
  • As Revlimid sales fall, Bristol Myers turns to its next multiple myeloma pill that's a molecular glue (Endpoints)
  • Zevra beefs up rare disease portfolio via $91M acquisition of Acer Therapeutics (Endpoints)
  • Alkermes, Teva settle patent suit around opioid-blocker Vivitrol, paving way for generics after three-year fight (Endpoints)
  • Exclusive: Stem cell scientist and bit.bio founder launches new startup with goal of extending healthspan by 20 years (Endpoints)
  • Sanofi taps serial biotech investor, entrepreneur as R&D chief — while promoting business operations, digital leaders (Endpoints)
  • Incyte nets soccer legend Mia Hamm for a personal touch on GvHD awareness (Fierce Pharma)
Medtech
  • Blood test for Parkinson's disease promising in early study (Reuters)
  • Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA (MedTech Dive)
  • No longer brushed off: A Minnesota clinic tries to rewrite medicine’s approach to miscarriage (STAT)
  • Unicorn down: Following layoffs, Biofourmis CEO quietly departs (STAT)
  • Abbott study shows benefits of OCT imaging in stent placement (MedTech Dive)
  • Why medtech firms are putting diabetes tech in consumer devices (MedTech Dive)
  • Trade groups urge CMS to expand, quickly finalize breakthrough device pathway (MedTech Dive)
Government, Regulatory & Legal
  • Drugmakers could find sympathetic US Supreme Court in drug pricing lawsuits (Reuters)
  • Medicaid rebukes states for mistakenly disenrolling children (STAT)
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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