Regulatory Focus™ > News Articles > 2020 > 1 > Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

Posted 17 January 2020 | By Michael Mezher 

Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA panel split over approval of Durect's non-opioid painkiller (Reuters) (Endpoints)
  • Republican FTC commissioner says she supports Medicare negotiating drug prices (The Hill) (STAT)
  • Novo Nordisk's diabetes pill Rybelsus to be covered by Express Scripts (Reuters)
  • Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication (Endpoints) (Press)
  • Opioid-Maker Insys Wins Court Approval of Bankruptcy Plan (WSJ)
  • Lilly exec says ‘there are no villains’ in the high-priced insulin market (STAT)
  • FDA-backed CBD drug brings in $296 million in ‘incredible launch year,’ GW Pharma CEO says (CNBC)
  • In active shopping mode, Eli Lilly plots one deal per quarter as it scouts 'Dermira-like' assets up to $5B (Endpoints)
  • Pay-for-delay patent settlements at the 3rd Circuit (Politico)
  • 'List price' for healthcare treatments in the US may be misleading (Reuters)
  • US vaping-related deaths rise to 60, cases of illness to 2,668 (Reuters)
In Focus: International
  • Big pharma failing to invest in new antibiotics, says WHO (The Guardian) (WHO)
  • The public science behind the ‘Merck’ Ebola vaccine (STAT)
  • China’s fourth richest man takes a back seat at the top drugmaker he built (Endpoints) (Fierce)
  • First Chinese biotech on Nasdaq in two years draws $104M (Endpoints)
  • EMA On Track To Install New Chief In November (Pink Sheet-$)
  • New EU Patent System On Course For End Of 2020, Says EPO (Pink Sheet-$)
  • Stealth Disease Likely To Blame For 20% Of Worldwide Deaths (NPR)
  • Genetically engineered mosquitoes resist spreading any form of dengue (Science Mag)
  • China says second person dies in Wuhan pneumonia outbreak (Reuters)
  • Launch of pilot programme for international cooperation in GMP inspections of manufacturers of sterile medicinal products for human use (WHO)
Pharmaceuticals & Biotechnology
  • The truth about JPM: Less is more (STAT)
  • A venture firm warms to funding neuroscience (STAT)
  • December ANDA Rush Is Largest Monthly Haul In Two Years (Pink Sheet-$)
  • ‘We have a tragedy of the commons’: How a VC thinks his new company can lower drug prices (STAT)
  • January 2020 Health Sector Economic Indicators Briefs (Altarum)
  • Civica advances drug supply strategy with Thermo Fisher deal (BioPharmaDive)
  • JPM: Biotech, VC execs on where the industry should look beyond cancer (Fierce)
  • Dangers of artificial intelligence in medicine (The Hill)
  • Patients with newly diagnosed musculoskeletal pain are prescribed opioids more often than recommended (NIH)
  • Novel Drug Candidate Aims To Tackle Superbug Infections In Cystic Fibrosis Patients (Forbes)
  • Microglia: a new target in the brain for depression, Alzheimer’s, and more? (STAT)
  • Frazier closes $617M life science fund, creating scope for bigger bets (Fierce)
  • PBM rebates lower premiums for healthy people, but don’t bring down drug costs, BMS chief says (MedCity)
  • At #JPM20, two CEOs, two radically different therapies, and a fight to chase down sickle cell (Endpoints)
  • Peter Ciriello takes over the reins at Vygon USA; Mirum Pharmaceuticals taps Ian Clements to the role of CFO (Endpoints)
  • After CES, Twitter exec highlights gadgets, gossip and buzz for pharma (Fierce)
  • Difelikefalin for the Treatment of Uremic Pruritus (NEJM)
  • A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants (NEJM)
  • FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility (FDA)
  • Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)
Medical Devices
  • 5 medtech trends to track in 2020 (MedtechDive)
  • Medtronic issues urgent field safety notice for O-arm imaging system (MassDevice)
  • Study of Abbott's HeartMate 3 points to single treatment indication for LVADs (MedtechDive)
US: Assorted & Government
  • Feinstein, Grassley, Capito, Durbin Introduce Bill to Stop Flow of Drugs to Pill Mills (Senate Judiciary)
  • HHS Drug Import Proposal Is Unlikely To Succeed (Law360-$)
  • Why are drug prices so high? Investigating the outdated US patent system (TED)
  • Gilead Hit With Another Antitrust Suit Over HIV Drugs (Law360-$)
  • Merck Says Ax Of $2.5B Patent Win A 'Disaster For Innovation' (Law360-$)
  • Edwards' US patent challenge to Abbott MitraClip IP denied (MedtechDive)
  • To rein in Big Pharma over high drug prices, start with patent reform (Roll Call)
  • Decade In Review: Biopharma's Shifting Legal Landscape (Pink Sheet-$)
  • Bayer close to Roundup settlement, mediator tells Bloomberg (Reuters)
  • State Court Reservations Cancelled for Litigation Tourists in Philadelphia Mesh Litigation (Drug & Device Law)
  • Chris Collins Won a 4th House Term While Indicted. Can He Avoid a Prison Term? (NYTimes)
Upcoming Meetings & Events Europe
  • UK trial aims to find treatments that can slow or reverse motor neurone disease (Pharmafile)
  • Inclusion of 26 new therapies on Hungary’s subsidy system welcomed by industry (PharmaLetter-$)
  • Electromagnetic interference: sources (MHRA)
  • Symptoms sometimes referred to as Breast Implant Illness (MHRA)
  • No Evidence of Off-label Use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: A Drug Utilization Study (Nature)
  • Japan 2010s In Review: Specialize, Focus, Innovate (Scrip-$)
  • Korean Pharma Highlights R&D Progress, 2020 Strategy At JPM (Scrip-$)
  • Celltrion CEO says China is next move on its game board for biosimilar production: report (Fierce)
  • Astellas Announces Construction of New Manufacturing Facility for Active Pharmaceutical Ingredient of Prograf® in Toyama Technology Center (Press)
  • Indian regulator allows price hikes for Cipla and Glenmark (PharmaLetter-$)
  • IMA urges PM to prove veracity of claim about pharma companies bribing doctors (Pharmabiz)
  • Medical device industry seeks predictable WTO permissible tariff structure to boost domestic market (Pharmabiz)
General Health & Other Interesting Articles
  • Health Care Costs Are Rising. Fund Returns Are Less Reliable. (NYTimes)
  • Smartwatch band may help spot heart problems, but doctors still required (Reuters)
  • Health warning: How Fitbits can help predict flu outbreaks (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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