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

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement – 4 March 2020
• Food and Drug Administration Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development – 24 February 2020

• 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)

• 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)