Recon: FDA approves Bluebird’s beta-thalassemia gene therapy; WHO recommends Valneva COVID vaccine
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)
- 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)
- 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)
- Plaintiff in first Zantac lawsuit set for trial drops case (Reuters)
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