Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA warns of pacemaker-iPhone interference (Healthcare IT News)
- Opinion: Expanding the domestic public health supply chain is a matter of national security (STAT)
- BD gets emergency FDA nod for smartphone-enabled COVID-19 antigen test (MedTech Dive)
- Ivermectin Scripts, Poison Center Calls Boom During Delta Surge (MPT)
- U.S. COVID-19 tests again in short supply as infections soar, schools reopen (Reuters)
- States Pull Back on Covid Data Even Amid Delta Surge (KHN)
- Regeneron, GSK see massive spike in Covid-19 mAb demand as US debates buying more (Endpoints)
- Medicaid Vaccination Rates Founder as States Struggle to Immunize Their Poorest Residents (KHN)
- The Biden administration is being criticized for falling short on its pledge to provide vaccines to the world (NYT)
- EU says Moderna COVID vaccine production can continue after contamination incident (Reuters)
- BioNTech selects Rwanda, Senegal for potential malaria and tuberculosis mRNA vaccine manufacturing (Fierce)
- Malaysia, Singapore Join Hands On Review Of Generic Drugs (Pink Sheet)
- Mexico introduces new decree on health regulation (GaBi)
- European Commission grants conditional approval of Minjuvi (Pharmaletter)
- Why Is It Taking So Long to Get a Covid Vaccine for Kids? (NYT)
- Vaccine inequality could cost the global economy trillions, report finds (CNBC)
- Global policymakers urge more sharing of COVID-19 vaccine (Reuters)
- Brii’s antibody combination could offer new COVID-19 option (Pharmaletter)
- Covid — not vaccination — presents biggest blood clot risk, large study finds (CNBC)
- Eurofarma to manufacturer Pfizer-BioNTech COVID-19 shot for Latin American market: Production set to exceed 100 million doses annually (BioPharma Reporter)
- Humacyte $245 million richer after SPAC deal ahead of Nasdaq debut (Pharmaletter)
- Vaxneuvance meets immunogenicity and safety endpoints in Phase III trial (EPR)
- Agenus, with FDA approval in sight, showcases anti-PD-1 data (Fierce)
- Xywav set to become Jazz’s next blockbuster in the narcolepsy market, says analyst (Pharmaletter)
- BeyondSpring, flying high from phase 3 success, sells Chinese rights to cancer drug (Fierce)
- Neurogastrx: $60M crossover round to advance de-risked GI assets (Biocentury)
- COVID shot drives CanSinoBIO's first six-month profit since at least 2019 (Reuters)
- Bolt, Innovent partner on non-traditional antibody conjugates (Biocentury)
- Backed by Eli Lilly, a little-known and secretive Chinese biotech fills the tank as it heads to the clinic (Endpoints)
- Foreign API Manufacturing Dominance Requires Long-Term Federal Intervention: Report (FDA News)
- Sesen Bio Withdraws EU Application for Cancer Drug FDA Just Turned Down (FDA News)
- Blood cancer therapy market: opportunities and challenges (Pharmaletter)
- Real-World Data: ‘Don’t Take Your Foot Off the Gas’ (Pink Sheet)
- Mayo, Verily strike two-year partnership to build decision support tools (MedCity News)
- Pharmacist-driven biosimilar substitution saves money (GaBi)
- Foundation Medicine, Epic partner to integrate genomic insights into EHR (MedCity News)
- Class 2 Device Recall Terumo Advanced Perfusion System 1 (FDA)
- Demand for Qiagen's COVID-19 tests 'is here to stay' – CFO (Reuters)
- New 3D Dental Tech Spin Out: Osteoid (MD+DI)
- AppliedVR, Curebase to launch five studies of VR for chronic pain (MD+DI)
- BOLD Laser Automation Debuts Laser Tools for Catheters and Stents (MD+DI)
- BMS to seek review of CAFC’s reversal of $1.2B judgment against Gilead (Biocentury)
- The Cassava saga continues as testing partner denies preparing tainted Alzheimer's data (Endpoints)
- Elizabeth Holmes Mental Health Docs May Be Unsealed Soon (Law360)
- Bankruptcy judge: J&J can spin talc powder into different company, potentially slowing plaintiffs' payouts (Endpoints)
- Stem Cell Clinic Says Ga. Lacks Authority To Bring $6.4M Suit (Law360)
- Chancery Tosses Class Suit Over $3B Zimmer Biomet Cashout (Law360)
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