Regulatory Focus™ > News Articles > 2020 > 8 > Recon: FDA expands use of remdesivir for COVID-19; Nestle to buy Aimmune for $2B

Recon: FDA expands use of remdesivir for COVID-19; Nestle to buy Aimmune for $2B

Posted 31 August 2020 | By Michael Mezher 

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.

 

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