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September 25, 2020
by Michael Mezher

Recon: AstraZeneca gets partial liability protection in EU vaccine deal; Novavax COVID vaccine enters Phase 3

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • How Trump is undermining his own vaccine race (Politico)
  • Trump signs US healthcare executive orders that may have little impact (Reuters) (WSJ)
  • Trump promises drug discount cards as a $200 pre-election gift (NYTimes) (STAT) (Reuters) (Politico)
  • Cuomo says New York to review any COVID-19 vaccine authorized by federal government (Reuters) (NPR)
  • US vaccine program chief backs stricter rules for emergency use of COVID-19 shot (Reuters)
  • Next ‘Warp Speed’ Vaccine Matches Merck Experimental Product (Bloomberg)
  • J&J signs manufacturing deal with GRAM for potential COVID-19 vaccine (Reuters)
  • US appeals court rejects novel opioid settlement framework (Reuters)
  • FDA flags health risks from 'Benadryl Challenge' (Reuters) (FDA)
In Focus: International
  • AstraZeneca gets partial immunity in low-cost EU vaccine deal (Reuters)
  • China's annual mgf. capacity of COVID-19 vaccines expected to hit 610M by end-2020 (Reuters)
  • A Bet on Europe Is a Bet on Drugs, Against Tech (WSJ)
  • French labs show how global supply bottlenecks thwart effort to ramp up testing (Reuters)
  • Novavax Enters Final Stage of Coronavirus Vaccine Trials (NYTimes)
  • Endo starts manufacturing Novavax's potential COVID-19 vaccine (Reuters)
  • Mexico has signed commitment to buy COVID-19 vaccines through COVAX (Reuters)
  • Brazil to join COVAX vaccine facility, as Chile, Israel, UAE also sign up (Reuters)
  • Some northern hemisphere countries struggling to source more flu vaccines: WHO (Reuters)
  • Gilead's rheumatoid arthritis med filgotinib, after cold shoulder from FDA, wins global-first nod in Japan (Fierce)
Coronavirus Pandemic
  • Trouble at the FDA and CDC (In The Pipeline)
  • Science academies sound alarm on political interference (Politico)
  • 'We need science to be the place of trust': How politics undermined the vaccine race (Politico)
  • As FDA buckles under the strain of a pandemic workload, Trump again accuses the agency of a political hit job (Endpoints)
  • Drugmakers push forward on large-scale production of coronavirus vaccines (BioPharmaDive)
  • HHS wants to test 30% of U.S. wastewater for the coronavirus as an ‘early warning system’ (CNBC)
  • Member of health secretary's security detail tests positive for coronavirus (Politico)
  • China says WHO gave blessing for coronavirus vaccine emergency use programme (Reuters)
  • Matt Hancock denies conflict of interest in Patrick Vallance holding vaccine company shares (Evening Standard)
  • Africa has held off the worst of the coronavirus. Researchers are working to figure out how. (NBC)
  • UK study shows rapid test has diagnostic sensitivity over 99% (Reuters)
  • U.S. records over seven million COVID-19 cases as Midwest outbreak surges (Reuters)
  • The ventilators never came: How graft hampered Brazil's COVID-19 response (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup September 24, 2020 (FDA)
Pharma & Biotech
  • EMA Explains Dos And Don’ts Of New Clinical Trials Portal (Pink Sheet)
  • Play-by-play of Gilead's $21B Immunomedics buyout details a frenzied push leading up to ESMO (Endpoints)
  • Accord Healthcare launches Herceptin biosimilar in the UK (PharmaTimes)
  • FDA sets January decision date for Xalkori in ALK-positive lymphoma (PMLive)
  • Flagship's Valo emerges with $100M and plans to transform R&D (Fierce)
  • The window is wide open as four more biotechs join the go-go IPO class of 2020 (Endpoints)
  • Silverback dishes out two promotions in C-suite; Legend CEO post changes hands again (Endpoints)
  • Gene therapy company Taysha completes sprint from first funding to IPO (BioPharmaDive)
  • J&J offers PhI/IIa data showing its single-dose vaccine can stir up sufficient immune response (Endpoints)
  • Palladio bags $20 million Series B to topple a problematic kidney disease drug (Endpoints)
  • ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Press)
  • Newly prequalified Active Pharmaceutical Ingredient (API) (WHO)
Medtech
  • Medtronic-Axonics sacral neuromod patent battle heats up (MedtechDive)
  • AdvaMed Launches Effort To Fight Misleading Lawsuit Ads (MedtechInsight)
  • Exact Sciences wows investors with preliminary multi-cancer liquid biopsy data (MedtechDive)
  • Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication (FDA)
Government, Regulatory & Legal
  • J&J's next-gen Darzalex sparks drug delivery royalties battle (Fierce)
  • Blue Cross Insurers Reach Tentative Settlement in Antitrust Lawsuit (NYTimes)
  • Opioid MDL Negotiating Class Struck Down By 6th Circ. (Law360)
  • D.C. Circ. Ponders $600M Rebate Switch Against Mallinckrodt (Law360)
  • Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions (Big Molecule Watch)
  • Justice Department Announces Results in Fight Against the Opioid Crisis Two Years after Launch of Operation S.O.S. (DOJ)
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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