Recon: FDA expands use of remdesivir for COVID-19; Nestle to buy Aimmune for $2B
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
FDA head says he is willing to fast-track Covid-19 vaccine (FT ) (Reuters ) (The Hill )
FDA expands emergency use of Gilead's remdesivir in hospitalized COVID-19 patients (Reuters ) (FDA )
GSK, partner Vir join race to find COVID-19 antibody treatment (Reuters ) (STAT )
US scraps Philips ventilator order in 2020 earnings blow (Reuters )
US government’s Darpa probes Moderna’s vaccine patents (FT )
Moderna failed to disclose federal funding for vaccine patent applications, advocates say (STAT )
US Will Revive Global Virus-Hunting Effort Ended Last Year (NYTimes )
GoodRx files to go public with a rare characteristic: Profits (CNBC ) (Endpoints )
Inside Trump’s pressure campaign on federal scientists over a covid-19 treatment (Washington Post )
In Focus: International
Nestle pays $2 billion to secure Aimmune's allergy treatment (Reuters ) (Financial Times ) (Endpoints )
Chinese Covid-19 Vaccine Maker in Talks With Countries on Early Approval (WSJ )
Scientists see downsides to top COVID-19 vaccines from Russia, China (Reuters )
Explainer: How common cold viruses are being used in vaccines from Russia, China (Reuters )
EU offers 400 million euros to WHO-led COVID-19 vaccine initiative (Reuters )
Canada to purchase 76 million doses of Novavax coronavirus vaccine, company says (CNBC )
Germany eyes global health ambitions as US steps back (Politico )
COVID-19 can wipe out health care progress in short order: WHO (Reuters )
Daiichi Sankyo's COVID-19 vaccine selected by Japanese drug discovery body (Reuters )
More than 2,000 Australians a year dying from drug overdoses (The Guardian )
Coronavirus Pandemic
Industry group says FDA botched COVID-19 convalescent plasma guidance (PharmaPhorum )
Poll: Most Americans believe the Covid-19 vaccine approval process is driven by politics, not science (STAT )
Here’s how the US could release a COVID-19 vaccine before the election—and why that scares some (Science )
Abbott is testing its rapid coronavirus test on asymptomatic people in hopes of expanding FDA authorization (CNBC )
European Leaders Weigh New Lockdowns as Cases Rise (NYTimes )
Coronavirus Notebook: UK Reveals Plans For Pre-Approval Use Of COVID-19 Vaccine (Pink Sheet )
Pharma & Biotech
Roche to Close Puerto Rico Plant After More Than Four Decades (Bloomberg )
With latest data, a gene therapy for a deadly brain disease inches closer to market (BioPharmaDive )
BioMarin's hemophilia gene therapy could have warranted a record price tag, ICER finds (BioPharmaDive )
Nearly a year since opening its doors, here’s how Verily’s addiction medicine campus is taking shape (STAT )
Ionis strikes deal to buy back lipid disease spinout Akcea (Fierce ) (Endpoints )
ESC: Merck's Steglatro shows limited promise with heart failure hospitalization data (Fierce )
ESC: Novartis' Entresto racks up a heart failure study win—but it's a mixed one (Fierce )
ESC: AstraZeneca's Farxiga cuts kidney disease risks by 39% in trial that could 'rewrite' the treatment textbook (Fierce )
ESC: Amgen chases pediatric use for cholesterol-busting PCSK9 med Repatha (Fierce )
ESC: Pfizer, BMS' Eliquis tops Xarelto, vitamin K drugs for site-specific bleeding risks in French real-world study (Fierce )
ESC: Eli Lilly, Boehringer's Jardiance slices CV events by 25% in Farxiga-matching heart failure trial (Fierce )
ESC: Amarin's Vascepa reduces patients' arterial plaque after 18 months of treatment (Fierce )
ESC: MyoKardia's mavacamten boosts heart function in phase 3, teeing up 2021 filing (Fierce )
Romark snares FDA nod to make diarrhea med Alinia at Puerto Rico plant—and supply a COVID-19 candidate's trials, too (Fierce )
Gene therapy upstart recruits more ex-AveXis talent; I-Mab reveals first-half results (Endpoints )
Novartis says its Soliris add-on might be able to replace the Alexion drug altogether. But is it too late? (Endpoints )
Sold for pennies, Unum gets one last shot at redemption (Endpoints )
How EFPIA Set The Bar On Drug Safety Reporting During COVID-19 (Pink Sheet )
China Regulatory Express: Former CFDA Commissioner Bi Makes Comeback (Pink Sheet )
Kymera Debuts On The Public Markets (LifeSciVC )
Medtech
Stryker again extends tender offer for Wright Medical shares (MedtechDive )
Quality Problems With Medical Gowns Leads To FDA Warning (MedtechInsight )
Philips pens $275M Intact Vascular deal to acquire implant (MedtechDive )
FAQ Sheet From HHS Says FDA ‘Rarely Enforced’ Premarket Review Of LDTs (MedtechInsight )
Tandem's artificial pancreas shows real-world blood sugar control in young children with Type 1 diabetes (Fierce )
Elon Musk’s Neuralink unveils prototype of brain implants — and looks toward clinical trials (STAT )
Baxter Announces FDA De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy (Press )
Government, Regulatory & Legal
First PREP Act Immunity Decision That We’ve Seen (Drug & Device Law )
Theranos Ex-COO Wants Latest Indictments Dismissed (Law360 )
Hologic Gets NovaSure Patent Judgment Bumped Up To $7M (Law360 )
Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2020) (Patent Docs )
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.