Recon: FDA approves Bluebird’s beta-thalassemia gene therapy; WHO recommends Valneva COVID vaccine

| 18 August 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Bluebird's $2.8 million gene therapy becomes most expensive drug after U.S. approval (Reuters) (Endpoints) (STAT) (FDA)
  • FDA says faulty Philips device reports accelerating as CEO departs (Reuters 1, 2)
  • HHS says it plans to extend Covid-19 public health emergency (Politico)
  • White House: Updated boosters for adults, teens expected in a few weeks (The Hill)
  • US plans shift to private market sales of COVID-19 vaccines, drugs (BioPharmaDive)
  • U.S. to boost monkeypox vaccine supply, adding 1.8 million doses (Reuters)
  • CDC director orders agency overhaul, admitting flawed Covid-19 response (Politico) (NYTimes) (Reuters)
  • CVS, Walgreens and Walmart Must Pay $650.5 Million in Ohio Opioids Case (NYTimes) (Reuters)
  • Valneva: U.S. Dept of Defense ends Ixiaro vaccine supply deal (Reuters)
  • Endo files for bankruptcy as U.S. opioid litigation drags (Reuters)
  • Pharma’s likely to sue over Medicare negotiation. Here are the arguments they might use (STAT)
  • ‘A blind eye’: NIH fails to ensure clinical trial results are reported, and still funds researchers who don’t file results (STAT)
In Focus: International
  • WHO recommends Valneva's COVID vaccine (Reuters)
  • Sanofi drops experimental breast cancer drug after second trial fails (FT) (Reuters)
  • EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine (EMA)
  • UK’s NICE Outlines Standards That AI and Data-Driven Medtech Should Meet For NHS Uptake (MedtechInsight)
  • Germany's constitutional court upholds measles vaccine mandate for children (Reuters)
  • Takeda's dengue vaccine expected to be approved in Indonesia soon -Nikkei (Reuters)
  • GSK lands first-ever UNICEF contract for malaria vaccine worth $170M (Endpoints)
  • WHO vows nothing 'ridiculous' as public submits ideas to rename monkeypox (Reuters)
  • Australia biotech giant CSL reports profit dip, flags cost spiral (Reuters)
Pharma & Biotech
  • Moderna, after firing newly hired CFO, finds replacement in PerkinElmer executive (MedtechDive)
  • Those big billion-dollar PhIII studies? Martin Landray says they can be done for a tiny fraction of the cost (Endpoints)
  • WuXi breaks ground on Delaware facility, boosting its US presence (Endpoints)
  • CSL says drug for rare swelling disorder succeeds in late-stage study (BioPharmaDive)
  • Blueprint Medicines drug reduces mastocytosis symptoms in a new study, meeting investor expectations (STAT)
  • Ex-Google CEO’s VC firm brings in hype-busting researcher to expand its biotech investments (STAT)
  • Akili’s deal to go public via SPAC could close soon (STAT)
  • ‘We’re finally here’: Harvard graduate spearheads custom gene therapy for younger brother (STAT)
  • Curis gets FDA green light to restart lymphoma trial, though partial hold on leukemia study stays in place (Fierce)
  • Bayer parts ways with Exscientia, leaving one target in AI drug hunter's hands (Fierce)
  • CureVac, GSK load into starting block in omicron booster race (Fierce)
  • Astellas' menopause therapy accepted for FDA review 5 months after late-phase study mars record (Fierce)
  • Amylyx ALS Drug: ICER Revised Evidence Report Casts Doubt On Firm’s New Data Analyses (Pink Sheet)
  • China's Jemincare nabs $650M biobucks pact with Roche's Genentech for prostate cancer hopeful (Fierce)
  • CSL CEO Paul Perreault determined to grow plasma collection after full-year sales dip (Endpoints)
  • Visibly wins FDA clearance for self-administered online vision test (MedtechDive)
  • FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection (FDA)
  • NIH-backed research turns out same-day, point-of-care abnormal fetal chromosome test (Fierce)
  • Qiagen joins monkeypox test-making efforts with 6-in-one assay (Fierce)
  • As Cyberattacks On Hospitals Rise, Medical Devices Are Particularly Vulnerable (MedtechInsight)
Government, Regulatory & Legal
  • Plaintiff in first Zantac lawsuit set for trial drops case (Reuters)
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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