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

• 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)