Recon: United Therapeutics Licenses Arena’s Ph. III PAH Drug for $800M

• Alexander: China Can Become the Global Leader in Stopping Synthetic Opioids (Sen. Alexander)
• United Therapeutics pays $800M-plus to grab Arena’s PhIII PAH drug (Endpoints) (STAT) (Press)
• FDA official hints at a tough road ahead for ‘right to try’ (STAT)
• Biotech is looking woozy: ferocious selling and a sense of foreboding (STAT)
• Lower Drug Prices Get an Assist From a Big Player (Bloomberg)
• FDA, Industry Willing to Collaborate on Dx Regulation via Legislation Despite Differences (GenomeWeb)
• Eli Lilly files for FDA approval of migraine drug lasmiditan (Fierce)
• Report: Opioid Epidemic Cost Massachusetts $15.2 Billion In 2017 (WBUR)
• Expensive, name-brand medications drive up drug spending (NBC)
• Merck starts rolling FDA submission for its Ebola vaccine, aiming to finish next year (Fierce)
• AbbVie preps uterine fibroid filing after phase 3 win (PMLive)
• U.S. Companies Are Fighting Their Big Pharma Addiction (NYTimes)
• Verma: CMS ready to roll on new Part B plan (Politico)
• Incoming Dem chairman: Medicare negotiating drug prices is a priority (The Hill)
• Offering free DNA sequencing, Nebula Genomics opens for business. But there’s an itsy-bitsy catch (STAT) (Xconomy)
• 20 Americans Die Each Day Waiting for Organs. Can Pigs Save Them? (NYTimes)

• Tens of thousands die in Africa each year due to fake drugs (Reuters)
• Novartis 'completely committed' to Sandoz, has no split-off plan (Reuters)
• Novartis files for Alcon spinoff, citing aging population and developing countries as top growth prospects (Fierce)
• French pharma group Ipsen closes in on its next drug deals (Reuters)
• Ipsen’s Cabometyx wins EU nod for liver cancer (PharmaTimes)
• Boehringer Ingelheim and Epizyme launch $300M precision oncology program (Fierce)
• China Biotech: Six things to watch in 2019 (KNect365)
• China NMPA Expands On Review Timeline For New Imported Drug Pathway (BioCentury)
• Scandals Catch Up to Private Chinese Hospitals, After Fortunes Are Made (NYTimes)
• UniQure’s hemophilia B gene therapy achieves 31% FIX activity (Fierce) (Xconomy) (Endpoints)
• Final NICE green light for Pfizer’s Mylotarg (PharmaTimes)
• Outcomes-Based Funding Deals On The Up In EU But Are They The Right Tool? (Pink Sheet-$)
• Alnylam Offering Value-Based Deals In EU For Breakthrough RNAi Drug Onpattro (SCRIP-$)
• No Quick End To Brexit Activity Hold At EMA (Pink Sheet-$)

• Tackling Cancer Anxiety (NYTimes)
• Billions Will Be Poured Into AI Drug Development (Forbes)
• Can Computer Simulations Enhance Vaccine Trials? (Harvard Bill of Health)
• Sick of a daily pill? A Boston biotech wants to make a daily Alzheimer’s drug last for a week — and they’re working on more (STAT)
• AbbVie enlists protein degradation experts at Mission for a new bet on Alzheimer’s, Parkinson’s (Endpoints)
• The sandbox: Parker Institute throws its research muscle behind gene therapy tech for destroying cancer cells (Endpoints)
• Synthorx Files for IPO to Advance Enhanced Cytokine Drugs (Xconomy)
• Cadent Pulls In $40M for Phase 2 Tests of Movement Disorder Drug (Xconomy) (Endpoints)
• California, Massachusetts go toe-to-toe for title of best biotech hub (BioPharmaDive)
• Healthcare will outspend all other industries on R&D by 2020, PwC says (HealthcareDive)
• Testosterone therapy could help tackle depression in men – study (The Guardian) (Forbes)
• What to Know About Getting a Flu Shot This Year, No Matter Who’s Paying (NYTimes)
• United Neuroscience’s ‘endobody’ Parkinson’s vaccine shows promise in early tests (Fierce)
• Nektar nabs Genentech I-O leader Wei Lin to head up its oncology programs (Fierce)
• Preclinical biotech Synthorx wants a $100M IPO (Fierce)
• Nitroglycerin patches may help ease tendon pain (Reuters)
• Dermavant hires Todd Zavodnick as CEO  (Fierce)

• FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas (Press)
• Five Prime Therapeutics Initiates Patient Dosing in a Phase 1 Clinical Trial of FPT155, a First-in-Class CD80 Fusion Protein (Press)
• TWi Biotechnology, Inc. Announces Last Patient Enrolled in Phase 2 Study of AC-201CR for Treatment of Hemophilic Arthropathy (Press)
• Alector Initiates Phase 1 Trial of AL002 for the Treatment of Patients with Alzheimer’s Disease (Press)
• Syros Announces Dose Escalation Data from Phase 1 Trial of SY-1365 Demonstrating Proof-of-Mechanism at Tolerable Doses in Patients with Advanced Solid Tumors (Press)
• Mallinckrodt's SpecGx LLC Reports on Outcome of FDA Joint Advisory Committee on Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride) (Press)
• PharmaCyte Biotech Completes Report of FDA Required Study Assessing Safety of Placement of Its Pancreatic Cancer Product (Press)

• GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling (FDA)
• Meet Lia: At-Home Pregnancy Steps Into The 21st Century (Forbes)
• Sen. Grassley grills FDA on cybersecurity improvements (MassDevice)
• Abbott’s wearable glucose monitor to be available across England (PMLive)
• Report: Med device recalls down in Q3 (Medical Design & Outsourcing)
• Merit Medical closes $200m Cianna Medical buy (MassDevice)
• Cochlear joins $17m round for sleep apnea nueromod dev Nyxoah (MassDevice)
• Canon Medical wins FDA nod for Vantage Orion 1.5T MRI (MassDevice)
• Cerus Endovascular starts European trial of intracranial aneurysm device (Medical Design & Outsourcing)

• Opioid Defendants Say Plaintiffs Stonewalling Them On Crucial Evidence (Forbes)
• Ginkgo Supplement Was Ginkgo-Free, U.S. Watchdog Finds (WSJ) (GAO)
• Johnson & Johnson scores back-to-back victories in talc mesothelioma cases (Fierce) (Reuters)
• FTC Shuts Down 1-800 Contacts Online Ad Compacts (Law360-$)
• Ranbaxy Consumers Denied Cert. In Drug Contamination Suit (Law360-$)
• Guest Post – Revisiting the Third Circuit’s Struggles With Design-Defect Preemption (Drug & Device Law)

• FDA Advisory Committee Calendar

• In Brief: Malaysian Regulators Launch New Medical Device Databases (Emergo)