Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal

ReconRecon | 27 August 2021 |  By 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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