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Regulatory Focus™ > News Articles > 2020 > 10 > Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

Posted 15 October 2020 | By Michael Mezher 

Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Chief Defends Vaccine-Trial Halts as Vital to Safety System (Bloomberg)
  • Examination shows how widely pharma showers campaign cash at the state level (STAT)
  • Vertex, Amgen could be seeking new deals to fuel growth following pipeline stumbles (STAT)
  • Vertex shelves experimental rare lung disease drug that once seemed promising (STAT)
  • First Ebola therapy approved by the FDA (STAT) (FDA)
  • Death in pivotal gene therapy trial rattles Sarepta partner already facing clinical hold (Endpoints)
  • States oppose settlement being negotiated by Purdue and Justice Department (Reuters)
  • FDA extends approval of pembrolizumab for classical Hodgkin lymphoma (FDA)
  • Eli Lilly bags an early-stage biotech for the neuro team — paying $135M cash and offering $1B-plus in milestones (Endpoints)
In Focus: International
  • China Drugmaker Gives Unproven Covid-19 Vaccine to Students Going Abroad (WSJ)
  • EU needs coordinated rules on quarantines, tests - EU executive chief (Reuters)
  • 'Time is running out,' EU warns, urging measures to avoid new lockdowns (Reuters)
  • Sanofi reports positive animal test results for potential COVID-19 vaccine (Reuters)
  • Germany has supply deals with Abbot, Roche and Healthineers for antigen tests (Reuters)
  • Roche sees problems from warehouse glitch in Britain 'cleared out' by weekend (Reuters)
  • Hundreds of advocacy groups urge WTO to waive IP rights to Covid-19 drugs and vaccines (STAT)
  • WHO vaccine drive bedevilled by familiar question: who pays if things go wrong? (Reuters)
  • Astellas wagers $425M-plus to buy a shot at hatching a 'neural dust' breakthrough in bioelectronics (Endpoints)
Coronavirus Pandemic
  • Early approval of a COVID-19 vaccine could stymie the hunt for better ones (Science)
  • 3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing. (NYTimes)
  • From EUA To Full Approval: CDER, CBER Still Developing Transition Plans (Pink Sheet)
  • Healthy young people might not be able to get the coronavirus vaccine until 2022, WHO says (CNBC)
  • Watch Healthy Returns: The path forward with the FDA’s Dr. Janet Woodcock (CNBC)
  • TimesRoche says broader tests needed for second Covid wave (Financial Times)
  • PMDA Gets Nearly 10 Requests for Free COVID-19 Vaccine Consultations in 2 Weeks (PharmaJapan)
  • Philippines eyes Sinovac trial as early as November (Reuters)
  • J&J-backed Cue gets $481M to onshore production of rapid COVID-19 test kit (MedtechDive)
Pharma & Biotech
  • Is the Trump Administration Eroding Trust in the FDA? (Undark)
  • Navigating the new ‘buy American’ drug landscape: opportunities for some, pitfalls for others (STAT)
  • Foresite pulls Gemini Therapeutics to Nasdaq in a quick $216M SPAC flip (Endpoints)
  • Is gene therapy ready to treat some forms of autism? (Science)
  • It’s Raining Biotech SPACs! (LifeSciVC)
  • Thermo Fisher will add 2 new filling lines to global expansion plans with $130M Singapore plant (Fierce)
  • Sage shares data on retreatment with depression drug zuranolone (Fierce)
  • NICE recommends Novartis’ Mayzent on the heels of SMC approval (PharmaTimes)
  • MHLW to Make “Comprehensive Decision” on Off-Year Drug Pricing Plan: Minister (PharmaJapan)
  • Gene Editing In China: EdiGene Raises Fresh Funds, Aims For First IND (Scrip)
  • Roche writes off ulcerative colitis portion of etrolizumab program, days after dissecting PhIII setback (Endpoints)
  • Keeping an 'immigrant mindset,' Flagship taps a self-professed nomad as CEO for their next-gen viral vector upstart (Endpoints)
  • Codiak lands on Wall Street in second shot at IPO, raises $83M (Endpoints)
  • News briefing: Otsuka’s $886M cancer drug is now a 3-time loser in PhIII; Keytruda approved for classical Hodgkin lymphoma (Endpoints)
  • Novartis vet Danny Bar-Zohar leaps back into R&D, taking over the development team at Merck KGaA as Luciano Rossetti steps out (Endpoints)
  • Merck, plagued by limited supply of bladder cancer drug, will build new facility to triple production (Fierce)
  • Vigilance And Postmarket Surveillance: Companies Must Avoid Getting Caught Out By May 2021 Deadline (MedtechInsight)
  • Old market, new growth: Medtronic and Axonics competition ups sacral neuromodulation's reach (MedtechDive)
  • With rivals delayed, Intuitive Surgical extends use of robotic instruments (MedtechDive)
  • Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics (MedtechDive)
Government, Regulatory & Legal
  • Medical Device Maker Merit Medical To Pay $18 Million To Settle Allegations Of Improper Payments To Physicians (DOJ)
  • Did OxyContin Labeling Change Help Fuel Opioid Epidemic? Republicans Want More Data From FDA (Pink Sheet)
  • FTC, State AGs Say Humira Judge Botched Actavis Reading (Law360)
  • Fed. Circ. OKs Ax Of Medtronic Suit In $112M Patent Dispute (Law360)
  • WuXi PharmaTech Dodges Securities Suit (Law360)
  • Allergan, Teva Sanctioned For Flouting Opioid MDL Discovery (Law360)
  • Florida Appellate Court Rejects Consumer Expectations Test for Design Defect Claims in Medical Device Cases (Drug & Device Law)
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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