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April 17, 2020
by Michael Mezher

Recon: Gilead jumps on early remdesivir reports; Moderna wins $483M BARDA contract for COVID-19 vaccine

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In Focus: US
  • FDA may have dropped standards too far in hunt for chloroquine to fight coronavirus (Reuters)
  • Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment (STAT) (Reuters) (In The Pipeline) (Financial Times)
  • Moderna receives $483M BARDA award for COVID-19 vaccine (Reuters) (Financial Times)
  • Institutional Investors Tell Big Pharma to Cooperate on Coronavirus (Reuters) (STAT)
  • What's in Trump's three-phase reopening plan (Politico)
  • Trump defends drop in commercial lab testing amid push to reopen US (Politico)
  • US intel community examining whether coronavirus emerged accidentally from a Chinese lab (NBC)
  • Lawmakers prep drug pricing wishlist for next relief package (Politico)
In Focus: International
  • If Sanofi’s coronavirus vaccine works, CEO says it can produce up to 600M doses next year (CNBC)
  • UK scientists to make a million potential COVID-19 vaccines before proof (Reuters)
  • Oxford set to start first UK coronavirus vaccine trial (Financial Times)
  • EU urges the World Health Assembly to pursue a voluntary pool for Covid-19 products (STAT)
  • China says nearly 1,300 virus deaths not counted in Wuhan, cites early lapses (Reuters)
  • Africa may see millions of coronavirus cases, tentative WHO forecast shows (Reuters)
  • At least 300,000 Africans expected to die in pandemic: UN agency (Reuters)
  • Congo records five new Ebola cases, shelves declaration of end to epidemic (Reuters)
  • EMA review of Picato concludes medicine’s risks outweigh its benefits (EMA)
  • Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data (EMA)
Coronavirus Pandemic
  • Influential Covid-19 model uses flawed methods and shouldn’t guide US policies, critics say (STAT)
  • How the Anti-Vaccine Community Is Responding to Covid-19 (Undark)
  • Switzerland's Roche joins global race to make coronavirus antibody tests (Reuters) (Press)
  • STD antibiotic faces shortages after Trump promotes it as coronavirus treatment (The Hill)
  • Trump Calls This Drug a ‘Game Changer.’ Doctors Aren’t So Sure. (NYTimes)
  • France says no evidence COVID-19 linked to Wuhan research lab (Reuters)
  • Asthma Is Absent Among Top Covid-19 Risk Factors, Early Data Shows (NYTimes)
  • Obesity Linked to Severe Coronavirus Disease, Especially for Younger Patients (NYTimes)
  • Coronavirus clue? Most cases aboard U.S. aircraft carrier are symptom-free (Reuters)
  • Unapproved Chinese coronavirus antibody tests being used in at least 2 states (NBC)
  • U.S. officials run into dead ends in rush to find masks amid pandemic (Reuters)
  • Disposable N95 Masks Can Be Decontaminated, Researchers Confirm (NYTimes)
  • More Small Molecule Clinical Data Against Covid-19, As of April 16 (In The Pipeline)
  • Coronavirus (COVID-19) Update: Daily Roundup April 16, 2020 (FDA)
  • Rapid coronavirus test, commonly used in U.S., may miss infections in some situations (STAT)
  • To speed coronavirus testing, FDA greenlights a new type of nasal swab (STAT) (Reuters)
  • France's coronavirus death toll nears 18,000, but some good omens (Reuters)
  • Japan Declares Nationwide State Of Emergency As Coronavirus Spreads (NPR)
  • Moscow has more coronavirus cases than state testing shows, private lab data suggest (Reuters)
  • Germany's confirmed coronavirus cases rise by 3,380 to 133,830: RKI (Reuters)
  • Doctors Press F.D.A. to Let More Gay Men Donate Blood (NYTimes)
  • US FDA Sets Convalescent Plasma Access Recommendations For Coronavirus Patients (Pink Sheet)
Pharma & Biotech
  • With Federal Nod, Consumers Could Lose The Boost They Get From Drug ‘Coupons’ (KHN)
  • Value Creation And Destruction: Dispersion of Performance In Biotech IPOs (LifeSciVC)
  • Negative Cancer Trials Often Get Positive Spin at Meetings (Medpage)
  • AstraZeneca CEO Faces Shareholder Backlash on Pay (Bloomberg)
  • New study seeks to surface data to produce a stronger measles vaccine (STAT)
  • Novartis, Amgen tout Aimovig's benefits with real-world and long-term data (Fierce)
  • Biosimilar Sponsors Push US FDA To Speed Up Supplement Reviews (Pink Sheet)
  • Dorothee Kern’s path from basketball star to founder of billion-dollar biotech(s?); Five Prime Therapeutics hands the reins to Genentech vet (Endpoints)
  • Industry shows increased appetite for macrophage biology (Nature)
  • Lantern Pharma charts course for IPO with AI platform that shines light on failed cancer drugs (Endpoints)
  • Chinese antibody maker, famed for Ebola cocktail, notches $160M as it focuses on cancer, autoimmune drugs (Endpoints)
  • Antibiotic treatment for COVID-19 complications could fuel resistant bacteria (ScienceMag)
  • Giant viruses aren’t alive. So why have they stolen genes essential for life? (ScieneMag)
  • Govt lifts curbs on exports of formulations made from Paracetamol (Economic Times)
Medtech
  • Congress Is Investigating Whether a Ventilator Company Is Gouging the U.S. — and Why the Government Is Letting It Happen (ProPublica)
  • As Ventilators Become Crucial In Saving Lives, Repair Roadblocks Remain (KHN)
  • CRISPR And Spit Might Be Keys To Faster, Cheaper, Easier Tests For The Coronavirus (NPR)
  • GE, Ford sign $336 million federal contract to make ventilators for coronavirus outbreak (CNBC)
  • BioMérieux Reports 22 Percent Q1 Revenue Growth, Withdraws Full-Year Guidance (360dx)
  • Developing Antibody Tests Is Technically The Biggest COVID-19 Challenge Yet (MedtechInsight)
Government & Regulatory
  • Where Now For Italy’s Drug Price Transparency Crusade? (Pink Sheet)
  • Focusing On The Bigger Picture At The EMA (Pink Sheet)
  • Reopening the Country During COVID-19: Legal and Policy Issues (Harvard Bill of Health)
  • Novartis Must Face Retaliation Suit Over Kickback Scheme (Law360)
  • AbbVie Execs Want Out Of Humira Kickbacks Suit (Law360)
  • Ventilators and other devices intended for respiratory support for COVID-19 (TGA)
  • Regulation of thermometers for COVID-19 (TGA)
  • Reuse of face masks and gowns during the COVID-19 pandemic (TGA)
  • Consultation: Proposed amendments to the Poisons Standard - ACMS and Joint ACMS/ACCS meetings, June 2020 (TGA)
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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