Recon: Enanta Steps Forward in NASH Race; Zantac Recalls Continue

• Enanta Steps Forward in NASH Race, With Unclear Prospects (Xconomy) (Fierce) (Reuters) (Press)
• Seven years later, NIH center that aims to speed drugs to market faces challenges (Science)
• Opioid Defendants Air Concerns Ahead of Federal Trial in Ohio (WSJ-$)
• State loses bid for reargument in opioid lawsuit (AP)
• Zantac’s Original Maker Halts Shipping on Carcinogen Concern (Bloomberg)
• Medtronic bets on flexibility for its surgical robots (Evaluate)

• U.K.’s Corbyn promises to form a government-owned drug company to lower prices (Stat-$) (Evaluate) (Guardian)
• TÜV Rheinland Becomes 5th Notified Body Designated Under MDR (Focus)
• EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA)
• Health Canada says four more companies recalling versions of Zantac (Reuters)
• Recall of all preparations containing ranitidine from the Swiss market (Swissmedic)
• NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig (PMLive)
• UK sees disease outbreak risk as child vaccination rates drop (Reuters)
• Iran reveals plans to domestically produce 135 strategic drugs (Pharmafile)

• After Shingles Standout, Glaxo Hunts for the Next Vaccines (Bloomberg)
• GSK infuses $120M into next-gen manufacturing facilities at Upper Merion, PA (Endpoints)
• CAR-T with a new target could address cancer relapses (Fierce)
• Moderna will give Harvard researchers access to its RNA technology (Stat-$)
• Survey finds 60 percent of Mass. biotech workers would change job to get a better commute (Boston Globe)
• Health-Care Investor to Build Biotech Labs in Nomad (WSJ-$)
• California reports pharma increased list prices way above inflation (Stat-$)
• When Depression Is Like a Cancer (NY Times-$)
• What’s Crucial And What Isn’t (In the Pipeline)
• The industry that cries wolf: pharma and innovation (Stat-$)
• Special Report: New frontier in health fraud - Genetic tests of the elderly (Reuters)
• Thermo Fisher scaling single-use bioreactors up to 5,000 L (BioProcess International)
• Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (FDA)

• Evolution of the EU Biosimilar Framework: Past and Future (BioDrugs)
• Clinical Approach to Lactose Intolerance (JAMA)
• Update on the Pathogenesis of Chronic Obstructive Pulmonary Disease (NEJM)
• First-of-its-kind trial in ALS spurs hope for brutal disease (BioPharmaDive)
• Temporary Special Use Program to obtain and use NATPARA (parathyroid hormone) for Injection (Takeda)
• ZielBio Closes $25.1 Million Series A Financing (Press Release)
• Ancora Heart Announces Positive Safety and Efficacy Data from Study of First-of-Its-Kind Investigational Heart Failure Therapy (Press Release)

• Becton Dickinson CEO Vincent Forlenza to retire, succeeded by chief operating officer Thomas Polen (FirstWord Medtech)
• 23andMe, moving beyond consumer DNA tests, is building a clinical trial recruitment business (Stat)
• Two non-drug, device approaches to tackling the opioid crisis (MedCity News)
• FDA Approves Abbott's 'Low Dose' Neurostimulation Device for Chronic Pain (MDDI)

• Body-on-a-Chip Device Predicts Cancer Drug Responses (NIH)
• NIST Goes With the (Slow) Flow: New Technique Could Improve Biotech, Precision Medicine (NIST)
• An unprecedented opportunity for Washington to lower drug prices (The Hill)
• Gov't Claimants Want Insys Bankruptcy Converted To Ch. 7 (Law360-$)
• FDA Urges Broader Access To Naloxone To Avoid Opioid Overdose Deaths (Forbes) (Pink Sheet-$)
• Ex-FDA chief Gottlieb blames outbreak of deadly vaping illness on illegal nicotine products (CNBC)

• FDA Advisory Committee Calendar

• Updated Q&A on Safety Features for Medicinal Products (European Commission)
• Springworks’ nirogacestat receives EC orphan status (Pharmafile)
• European medicine supply: Access in the spotlight (InPharma-Technologist)
• Applying for a Certificate of Pharmaceutical Product after Brexit (MHRA)
• Neuromod Successfully Closes €8 Million Capital Raise (Press Release)

• Australian regulatory action on breast implants and breast tissue expanders (TGA)