rf-fullcolor.png

 

October 12, 2020
by Michael Mezher

Recon: New Zealand signs deal with Pfizer, BioNTech for 1.5M vaccine doses; Mallinckrodt files for bankruptcy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer trying to defuse critics amid push for vaccine before Election Day (Politico)
  • Trump’s Testimonial Is a Double-Edged Sword for Regeneron (NYTimes)
  • Can Trump Really Speed Approval of Covid Treatments? (NYTimes)
  • First, a Vaccine Approval. Then ‘Chaos and Confusion.’ (NYTimes)
  • Abbott wins US emergency use authorization for new COVID-19 antibody test (Reuters)
  • US should not approve vaccine based on UK trials, says Pelosi (FT)
  • Alkermes likely headed for approval after adcomm waves through schizophrenia and bipolar program (Endpoints) (Pink Sheet) (BioPharmaDive)
  • Mallinckrodt, beset by opioid drug suits, files for bankruptcy (BioPharmaDive)
In Focus: International
  • WHO says 180-plus countries including China committed to vaccine effort (Reuters)
  • New Zealand signs deal with Pfizer, BioNTech for COVID-19 vaccine (Reuters)
  • Second human trials of Russian COVID-19 vaccine abroad, in UAE, have launched – Kremlin (Reuters)
  • Thailand to make, supply AstraZeneca's COVID-19 vaccine (Reuters)
  • South Korea's Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug (Reuters)
  • South Korea's Daewoong Pharma gets approval for Phase 1 trials of COVID-19 anti-parasite drug (Reuters)
  • Can India, S Africa COVID-19 IPR Waiver Request Gain Traction? (Pink Sheet)
Coronavirus Pandemic
  • UK study tests if BCG vaccine protects against COVID (Reuters)
  • FDA's Hahn to Topol: Decisions Will Be Made Based on Science Alone (Medscape)
  • Covid virus ‘survives for 28 days’ in lab conditions (BBC)
  • Trump's Doctor Says There's No 'Actively Replicating Virus' — So Is He COVID-19 free? (NPR)
  • White House Blocked C.D.C. From Requiring Masks on Public Transportation (NYTimes)
  • A Coronavirus Vaccine Could Kill Half A Million Sharks, Conservationists Warn (NPR)
  • Call For Administration's COVID-19 Vaccine Contracts To Be Disclosed (NPR)
  • Nevada Revokes Halt on Rapid Antigen Testing in Nursing Homes (NYTimes)
  • Regeneron board member and executive sell $1 million in stock after Trump touts treatment (NBC)
  • Whistleblower On How Political Pressure Affects Safety Of Coronavirus Vaccines (NPR)
  • Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift (STAT)
  • AstraZeneca gets a $500M antibody contract, yet key questions still loom for Trump's new favorite treatment (Endpoints)
  • Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify (MedtechDive)
Pharma & Biotech
  • FDA new drug approvals in Q3 2020 (Nature)
  • FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price (Endpoints)
  • ‘We have to deal with uncertainty’: FDA leaders explain how Covid-19 has upended cancer research and care (STAT)
  • Time For Independent FDA? COVID-19 Political Pressure Reignites Debate (Pink Sheet)
  • OxyContin Abuse-Deterrent Postmarketing Data Are In. Now What? (Pink Sheet)
  • EU Regulatory Network 'Competing With Google' For Tech & AI Experts (Pink Sheet)
  • French To Speed Up Early Access Procedure (Pink Sheet)
  • UK MHRA Picks Pharmacovigilance For First AI Guideline (Pink Sheet)
  • Bob Langer-backed spinout shoots for $75M-plus IPO while biotech SPACs continue to rule on Wall Street (Endpoints)
  • News briefing: Gilead reveals more filgotinib data; Seagen and Astellas report new cohort for Padcev (Endpoints)
  • Lilly shows more positive Crohn's data for its IL-23 inhibitor as it continues to chase down rivals (Endpoints)
  • Novartis vets get $35M to pluck one of the pharma giant’s abandoned drugs off the shelf and put it back into a clinical trial (Endpoints)
  • Sami Anwar raked in millions of dollars gathering drug trial data at his sites. But it was all a lie — and now he's been sentenced to 28 years (Endpoints)
Medtech
  • 5 key exec insights from 2020's MedTech Conference (MedtechDive)
  • Olympus to roll out colonoscopy AI for spotting lesions, polyps in real time (Fierce)
  • HIMSSCast: Is the FDA taking digital health regulation in the right direction? (Mobihealthnews)
Government, Regulatory & Legal
  • Negotiation Class Wants 6th Circ. Full Review In Opioid MDL (Law360)
  • Opioid MDL Bellwether Trial Delayed Amid COVID-19 Fears (Law360)
  • J&J Opens Appeal By Assailing 'Radical' $465M Opioid Verdict (Law360)
  • Drug Cos. Fight Class Cert. For 'Opioid Babies' In MDL (Law360)
  • Prosthetic Maker Reaches Deal Over FTC's Merger Unwinding (Law360)
  • Allergan Escapes Ill. Suit Over Defective Breast Implants (Law360)
  • Eye Device Maker Gets Rival Product Blocked During IP Fight (Law360)
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.