Recon: New healthcare investing record; Sanofi slim-down, sell-off? – Regulatory Focus

Posted 19 October 2020 | By Kari Oakes 

Recon: New healthcare investing record; Sanofi slim-down, sell-off?
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • Cuomo: Public should be 'very skeptical' about COVID-19 vaccine (The Hill)
  • Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead (CNBC)
  • For Trump, Covid-19 therapeutics are the new vaccines (STAT)
  • Whatever happened to Deborah Birx? (The Hill)
  • What about the German negotiation model? Biden steers drug pricing debate to a showdown (Endpoints)
  • HHS lawyer warns Trump's vaccine discount for seniors could be illegal: report (The Hill) (Politico)
  • CDC to Review State and Local Vaccination Plans (FDA News)
  • There still aren't enough Covid-19 tests in the U.S. Will rapid tests help? (NBC)
  • COVID-19 Test Results Get Faster, But Still Too Slow To Help Slow Disease Spread (NPR)
  • Millions more virus rapid tests, but are results reported? (AP)
  • Coronavirus Cases Rise To Highest Level Since Late July (NPR)
  • Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community (NEJM)

In Focus: International

  • Shield defends patents against action from Teva (Pharmaletter)
  • WHO Addresses Pushback On Solidarity Trial Interim Results; Some Experts Say Remdesivir Still Potentially Effective In Early Infection (KFF)
  • Evotec nabs Gates Foundation cash for low-income country COVID-19 antibody work (Fierce Biotech)
  • Kamada to supply Israel with its experimental COVID-19 treatment (Reuters)
  • First results of Russian COVID vaccine trial to include data from 5,000-10,000 people: developers (Reuters)

Coronavirus Pandemic

  • 40 Million Coronavirus Cases Are Now Reported Worldwide (NPR) (CNBC) (Forbes)
  • Pfizer Reportedly Manufactures ‘Several Hundred Thousand’ Covid-19 Vaccines Anticipating November Regulatory Approval (Forbes)
  • Popular COVID-19 conspiracies linked to vaccine 'hesitancy' (PharmaNews)
  • STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping (STAT)
  • How Science Helped Jacinda Ardern, Labor Party Dominate New Zealand Election, Control Covid-19 Coronavirus (Forbes)
  • Italy announces new measures to stem spread of coronavirus (The Hill) (CNBC)
  • Spain's regions tighten COVID-19 measures as one million case milestone looms (Reuters)
  • U.K. COVID-19 Restrictions Tighten As Europe Sees Spike In Cases (NPR)
  • Wales imposes two-week lockdown: 'everybody must stay at home' (Reuters)
  • COVID-19 Cases Are Increasing In At Least 30 States (NPR)
  • As Covid-19 surges across Europe, countries fear drug shortages (NBC)
  • Some Signs of Recovery From Severe Covid Lung Damage (NYT)
  • CBD helps reduce lung damage from COVID by increasing levels of protective peptide (EurekAlert)
  • “Masks make you sicker”: The COVID-19 myth that just won’t die (Science-Based Medicine)
  • Vaccine Advisory Committee Will Expose Wide Audience To Uncertainties of Drug Development (Pink Sheet)
  • Op-Ed: Great Barrington vs John Snow Is a False Choice (MedPage Today)
  • Doctors are now probing whether COVID-19 is causing diabetes, even with no history (Economic Times/Reuters)
  • 'Bad math': Airlines' COVID safety analysis challenged by expert (Reuters)

Pharma & Biotech

  • Healthcare investing sets a new record in Q3 (MedCity News)
  • Sanofi, Pfizer & Bristol Drugs Among the 12 Approvals to Look Out for in Q4 (Xconomy)
  • Merck touts new data for Keytruda combos in NSCLC at North American conference (Endpoints)
  • Galapagos mid-stage trial failure raises concerns for Gilead deal (PMLive)
  • Praxis Precision Medicines Raises $190 Million in IPO to Translate Genetic Insights into CNS Disease Therapies (Global Genes)
  • Endo pays $658M in a further bet on collagen-based medicines, buying out longtime biopharma partner (Endpoints)
  • Sanofi, intent on slimming down, mulls $200M-plus sale of anti-inflammation meds: report (Fierce Pharma)
  • Roche's James Sabry inks his second AI deal in back-to-back pacts — this time partnering Genentech with Stanford spinout Genesis Therapeutics (Endpoints)
  • CAR-plus: Irish biotech recruits Kite alum Chris Nowers to prep dual-targeting NK cell therapy for the clinic (Endpoints)
  • How some biotechs are cramming multiple fundraising rounds into a single year (STAT)
  • Breast cancer study uncovers new RNA targets for treatment and diagnostics (Fierce Biotech)
  • Super-secretive anti-aging biotech Calico tees up the first visible clinical trial of an experimental drug. And it’s for cancer? (Endpoints)


  • Op-Ed: Addressing Our Da Vinci Addiction (MedPage Today)
  • Eargo goes public with an upsized IPO worth $141.3 million (MobiHealth News)
  • Two healthcare apps available for prescription in Germany for first time (Healthcare IT News)
  • Apple, Google, Amazon And The $9 Trillion Battle Over The Future Of HealthTech: Former Apple CEO John Sculley (Forbes)
  • FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up (MedTech Dive)

Government & Regulatory 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.
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