rf-fullcolor.png

 

October 19, 2020
by Kari Oakes

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

Recon:
 
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)
Medtech
  • 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.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
 
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.