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Recon: FDA grants priority review for traditional approval of Biogen, Eisai’s Leqembi; Merck drug shows promise in pulmonary hypertension

ReconRecon | 06 March 2023 |  By 

Recon: FDA grants priority review for traditional approval of Biogen, Eisai’s Leqembi; Merck drug shows promise in pulmonary hypertension

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Merck's drug boosts exercise capacity in pulmonary hypertension patients (Reuters) (STAT)
  • After its drug was shown to prevent heart attacks, what’s next for Esperion? (STAT) (NYTimes)
  • Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab (Reuters) (Endpoints)
  • Aclaris shares tank as skin disorder drug fails mid-stage study (Reuters)
  • FDA says no indication contaminated cough syrups have entered U.S. supply chain (Reuters)
  • Walgreens won't dispense abortion pills in some Republican states (Reuters)
  • ‘Dangerous and unacceptable’: White House condemns efforts to stop pharmacies from dispensing abortion pills (Politico)
  • FDA widens Lilly's Verzenio breast cancer reach, removes test and menopausal status demands (Fierce) (FDA)
  • FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency (BioPharmaDive)
  • More Doctors Can Now Prescribe a Key Opioid Treatment. Will It Help? (NYTimes)
  • There’s a new US national security obsession — biotech (FT)
In Focus: International
  • AstraZeneca cancer drug Enhertu show encouraging initial results for other tumors (Reuters)
  • Exclusive: India may issue alert on Marion cough syrup exports after toxins found (Reuters)
  • China to promote vaccine development, new medicines (Reuters)
  • Europe will lose out on medical innovation if draft EU reforms pass -Novo Nordisk CEO (Reuters)
  • Moderna chooses Oxfordshire for new UK facility (Pharmafile)
  • At genome-editing summit, experts worry that rule changes on embryo research in China fall short (STAT)
  • Japanese pharmaceutical firm Takeda lowers price of dengue shot in Brazil and Indonesia (Japan Times)
  • Scotland first to ban environmentally harmful anaesthetic (BBC)
Pharma & Biotech
  • FDA cites Cipla for placing important manufacturing records in the trash (STAT) (Endpoints)
  • Orchard lines up money for proposed Libmeldy expansion; Harbour touts PhIII (Endpoints)
  • Heart repair, risky genes, and AI: the buzz from a giant cardiovascular conference (STAT)
  • French CAR-T biotech Mnemo Therapeutics shutters US operations (Reuters)
  • BridgeBio’s treatment for genetic cause of dwarfism accelerates growth in small study (STAT)
  • Red Tree, RA Capital lead $108M infusion into Bicara and its bifunctional I/O drug (Reuters)
  • Albuterol shortage could worsen after asthma drugmaker's closure (CBS)
  • Adaptimmune acquires struggling cell therapy rival following layoffs (BioPharmaDive)
  • Foundation charges cancer patients $83,000 for unproven but promising experimental drug (STAT)
  • Incyte stops PhIII trial for PI3K inhibitor after primary endpoint failure (Endpoints)
  • Voyager nabs $25M cash as Novartis runs with two AAV capsids for neuro gene therapy (Endpoints)
  • Q&A with Christine Baeder, new chair of the generic industry’s AAM (Endpoints)
  • Incyte's LIMBER lumbers to early end as analysis shows Jakafi cancer combo destined to fail (Fierce)
  • Harbour ships phase 3 data to take lead over argenx, J&J and UCB in Chinese autoimmune race (Fierce)
  • An mRNA vaccine for cancers associated with HPV shows promise in mice (STAT)
Medtech
  • Regulators Compare US, Japan Approaches To Digital Health (MedtechInsight)
  • Using A.I. to Detect Breast Cancer That Doctors Miss (NYTimes)
  • Abbott CGMs cleared to integrate with automated insulin delivery systems (MedtechDive)
  • Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards (MedtechDive)
  • Medtech industry relieved as Europe’s MDR extension nears final approval (MedtechDive)
  • FDA Class I recalls hit 15-year high in 2022 (MedtechDive)
  • Expert Panel Calls For More Trials And Restricted Clinical Use In Latest Cardiology Device Opinion (MedtechInsight)
  • Sooma Medical’s neurostim device for at-home depression treatment lands FDA breakthrough tag (Fierce)
  • FDA clears Galaxy robotic surgery system, sending lung cancer diagnosis to a new frontier (Fierce)
Government, Regulatory & Legal
  • United States Obtains Permanent Injunctions and Civil Penalties in Actions against California, Georgia, and Utah Distributors of Essential Oils and Nutritional Supplements (DoJ)
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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