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July 22, 2020
by Michael Mezher

Recon: US pays $1.95B for Pfizer, BioNTech COVID-19 vaccine; Biogen lifts forecast on Tecfidera sales

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End (NYTimes) (Press)
  • Exclusive: Novavax executives could get big payday even if vaccine fails (Reuters)
  • Among biotech venture capital firms, Flagship Pioneering got the best single-fund returns (STAT)
  • White House considers drug pricing executive order, prompting GOP pushback (The Hill)
  • AbbVie, famous for its Humira strategy, forms 'patent wall' around Imbruvica: report (Fierce)
  • Biogen lifts full-year profit forecast as Tecfidera boosts quarter (Reuters)
  • Biogen unexpectedly replaces CFO Capello with IQVIA vet, sparking M&A speculation (Fierce) (Endpoints)
In Focus: International
  • Merck taps contract research firm IRBM for peptides to hit back at pandemic virus (Fierce)
  • Pharmaceutical Strategy Could Save European ATMP Development (Pink Sheet)
  • Danish Agency To Buy New Pharmacovigilance System (Pink Sheet)
  • New COVID-19 Law Lab to provide vital legal information and support for the global COVID-19 response (WHO)
  • WHA Report on addressing the burden of epilepsy and other neurological disorders available online (WHO)
Coronavirus Pandemic
  • Trump tries to rebrand the coronavirus response (Politico) (CNBC)
  • Dr. Anthony Fauci warns the coronavirus won’t ever be eradicated (CNBC)
  • McConnell previews GOP coronavirus relief bill (The Hill)
  • Confusion spreads over system to determine priority access to Covid-19 vaccines (STAT)
  • Singapore greenlights clinical trials for vaccine candidate developed by Arcturus and Duke-NUS Medical School (CNBC)
  • LabCorp CEO says coronavirus in US is spreading faster than it can add testing capacity (CNBC)
  • Testing delays once again hamper COVID-19 response (The Hill)
  • Actual Covid-19 case count could be 6 to 24 times higher than official estimates, CDC study shows (STAT)
  • Ebola prepared these countries for coronavirus — but now even they are floundering (Nature)
  • Coronavirus (COVID-19) Update: Daily Roundup July 21, 2020 (FDA)
Pharma & Biotech
  • Pfizer, Amgen, GSK lead spike in digital ad spend during COVID-19 pandemic (Fierce)
  • Acadia pulls plug on pimavanserin for adjunctive MDD (PharmaTimes)
  • 'Missing link': Bayer, Morningside help catapult a new kind of delivery tech to cell and gene therapy (Endpoints) (Fierce)
  • Biogen's lagging Vumerity, stalled by the pandemic, faces 'critical' stretch ahead, CEO says (Fierce)
  • Clinical trials need to include more Black and other minority participants. Here’s how (STAT)
  • GV's David Schenkein comes in to help mentor — and bankroll — a gene therapy 2.0 player, intrigued by their ‘science heavy’ approach to conquering severe disease (Endpoints)
  • Can fully shutting down the estrogen receptor make a difference in breast cancer? Olema scores $54M to find out in the clinic (Endpoints)
  • Cullinan Oncology launches new subsidiary focused on collagen-binding cytokine treatment (Endpoints)
  • Ayahuasca inspires another biotech startup at ATAI; Mylan TB drug gets green light in India (Endpoints)
  • Seer raises another $55M and finally reveals proteomic tech — can it hold up? (Endpoints)
Medtech
  • Boston Scientific’s next-gen stroke prevention device gets FDA nod (MassDevice)
  • Thermo Fisher rises on COVID-19 response-driven Q2 (MassDevice)
  • Scientists inch closer to blood test to detect early stage cancer (NBC)
  • Switzerland approves MedDO revision and moves toward MDR harmonization (Emergo)
  • LifeSignals Receives US FDA Clearance To Market ECG Remote Monitoring Platform (MedtechInsight)
Government & Regulatory
  • HHS secretary’s wife has been lobbying the agency on behalf of health care companies (STAT)
  • Pay-For-Delay May Need More Evidence After 3rd Circ. Ruling (Law360)
  • Medicaid’s Multiple Best Price Proposal Needs More Clarity Before Advancing, PhRMA Argues (Pink Sheet)
  • Another Problem on the Health Horizon: Medicare Is Running Out of Money (KHN)
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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