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Regulatory Focus™ > News Articles > 2020 > 11 > Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak

Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak

Posted 18 November 2020 | By Michael Mezher 

Recon: Judge approves $8.3B Purdue settlement; Congo declares end of Ebola outbreak

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days’ (NPR) (NYTimes) (STAT) (Reuters) (CNN) (Press)
  • FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization (CNBC)
  • Pfizer says analysis shows 3.8% of participants experienced fatigue (Reuters)
  • Americans Are More Willing to Take a Coronavirus Vaccine, Poll Suggests (NYTimes)
  • Pharma trade group issues guidelines for improving diversity of clinical trial participants (STAT) (Pink Sheet)
  • Purdue Pharma Gets Court Approval For $8B Deal With Feds (Law360) (NPR)
  • Indivior Solutions Sentenced as Part of $2 Billion Resolution of False Safety Claims Concerning Suboxone (FDA)
  • CEO of biotech group says lawsuits are on the table to stop Trump drug proposal (The Hill)
  • FDA gives Cellectis all clear after patient death halted off-the-shelf CAR-T trial (Endpoints)
In Focus: International
  • EU drug regulator says it received data from Pfizer on COVID vaccine large-scale trial (Reuters)
  • EU recommends use of COVID rapid tests after symptoms emerge (Reuters) (EC)
  • Spain authorises Phase III trial of Johnson & Johnson COVID-19 vaccine (Reuters)
  • Sinovac's COVID-19 vaccine induces quick immune response: study (Reuters)
  • Malaysia in deal with China for COVID-19 vaccine development (Reuters)
  • Congo declares end of Ebola outbreak, sees lessons for COVID fight (Reuters) (WHO)
  • Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021 (WHO)
Coronavirus Pandemic
  • The Vaccines Will Probably Work. Making Them Fast Will Be the Hard Part. (NYTimes)
  • Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines (KHN)
  • How the Out-of-Control Pandemic Is Speeding the Hunt for Vaccines (NYTimes)
  • Immunity to the Coronavirus May Last Years, New Data Hint (NYTimes)
  • Analysis: Can first COVID-19 vaccines bring herd immunity? Experts have doubts (Reuters)
  • In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests (MedtechDive)
  • As Mexico Surpasses 1 Million Coronavirus Cases, Government Tries To Secure Vaccine (NPR)
  • COVID-19 vaccine provisional determinations (TGA)
  • Expert outreach and collaboration on COVID-19 testing and screening (Health Canada)
  • Testing and Screening Expert Advisory Panel: Overview (Health Canada)
Pharma & Biotech
  • BsUFA III: Reauthorization Process Begins With US FDA Considering Staffing, Uptake Issues (Pink Sheet)
  • Children in U.S. May Miss 9 Million Vaccine Doses in 2020, Report Warns (NYTimes)
  • Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity (Pink Sheet)
  • Brexit: Companies Must ‘Act Now’ To Avoid Drug Supply Disruptions In 2021 (Pink Sheet)
  • EMA marks European Antibiotic Awareness Day (EMA)
  • Cambrex looks to fill 'onshore' API manufacturing demand with $50M expansion in Iowa (Fierce)
  • Stem cell therapy for ALS fails a large clinical trial (BioPharmaDive)
  • Pfizer and Vivet get the OK to start gene therapy trial for rare liver disorder; Florida biotech inks $50M China deal (Endpoints)
  • Gilead touts pivotal data for new kind of HIV therapy, opening towards large potential market (Endpoints)
  • NICE's thumbs-up on Lilly's migraine med Emgality leaves rivals from Novartis and Teva in the dust (Fierce)
  • Celltrion plots $453M South Korean expansion to aid ambitious biosimilar pipeline push: report (Fierce) (Endpoints)
  • Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia (Press)
  • Analysts poured cold water, but FDA gives a fast-pass for Sanofi's new Pompe disease drug (Endpoints) (Press)
  • 4DMT shoots for a $75M IPO, its second attempt to go public with its gene therapy vector programs (Endpoints)
  • Pharvaris lands another $80M as it looks to tackle Takeda and CSL with an oral approach for HAE (Endpoints)
  • ViiV’s cabotegravir scores breakthrough designation for HIV prevention (PharmaTimes) (Press)
  • AZ’s Brilinta reduced rate of stroke and death in high-risk subgroup (PharmaTimes)
  • Elevation Oncology bags $65M to push failed Merrimack drug through PhII (Endpoints)
  • Survey of U.S. Rheumatologists Suggests Acceptance of Biosimilars for Treatment of New Patients, but Reluctance to Switch Patients from Reference Products (Big Molecule Watch)
  • 15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (EMA)
Medtech
  • FDA Official Confirms 2021 For Release Of Draft QSR, Asks For ‘Inclusive Comment Spectrum (MedtechInsight)
  • In brief: Malaysia MDA introduces new searchable medical device database (Emergo)
  • Boston Scientific to lay off 106 following Lotus Edge heart valve retirement (MassDevice)
  • FDA clears Allotrope StimSite (MassDevice)
Government, Regulatory & Legal
  • Pharma lobbyist and longtime Biden loyalist Steve Ricchetti joins the inner circle headed to the White House as drug pricing remains a hot topic (Endpoints)
  • Amgen, GSK Urge Justices To Allow Patents On Genus Claims (Law360)
  • House Passes Bipartisan Bills To Fight Opioid Crisis (Law360)
  • House Passes Bill Targeting Orphan Drug Exclusivity (Law360)
  • FTC Urges 3rd Circ. To Restore $448M AbbVie Penalty (Law360)
  • Fed. Circ. Ruling May Reshape Hatch-Waxman Litigation Map (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.

Tags: US, worldwide

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