Recon: Cigna Announces Plan to Cover Expensive Gene Therapies; BMS’ Opdivo Misses in Third Glioblastoma Trial

• A Turn for the Worse for Biotech Stocks (WSJ)
• Cigna rolls out new plan to fully cover multi-million dollar gene therapies (Reuters) (WSJ)
• BMS’ Opdivo fails third straight test in tough-to-treat brain cancer (Fierce) (Endpoints) (Press)
• Mallinckrodt Mulls Restructuring as a Major Opioid Trial Nears (Bloomberg) (Reuters)
• Drug Maker Mallinckrodt Agrees to Pay Over $15 Million to Resolve Alleged False Claims Act Liability for “Wining and Dining” Doctors (DoJ)
• J&J: The next target of anger over America’s opioid crisis (Financial Times)
• How much has the cancer R&D frenzy translated into drug approvals? A lot (Endpoints) (Pharmafile)
• Medical testing start-up uBiome files for bankruptcy (Financial Times) (CNBC)
• CVS-Aetna Merger Wins Antitrust Approval From Judge (NYTimes) (DoJ)
• Ultragenyx gene therapy data disappoints investors (BioPharmaDive)
• Next Up In China Trade War: Biotech Purge? (Forbes)

• PAG pays $540m for control of Chinese biotech start-up (Financial Times)
• Surging prescriptions, deaths: Australia faces opioid crisis (AP)
• How to Get TB Patients to Take Their Pills? Persistent Texting and a ‘Winners Circle’ (NYTimes)
• Ebola survivors face kidney problems and risk of premature death (Reuters)
• IFM sets up a 3-peat as Novartis funds cGAS/STING program, with $840M option to buy (Endpoints)
• Novartis selling manufacturing site to Chinese drugmaker (Fierce)
• Potential buyers size up Novartis site as layoffs loom for 400 workers (Fierce)
• Boehringer bolsters KRAS push with $720m Lupin deal (PMLive)
• China's New Pharma Law Leaves Key Questions Unanswered (Pink Sheet-$)
• Amid Brexit Chaos, UK Defers Life Sciences Spending Commitments (Pink Sheet-$)
• Ireland will not suffer immediate medicine shortages in event of no-deal Brexit (Pharmafile)
• WHO welcomes Facebook pledge to curb anti-vaccine misinformation (Reuters)

• Who is really behind a proposed new definition of pain? (STAT)
• Fentanyl As A Dark Web Profit Center, From Chinese Labs To U.S. Streets (NPR)
• As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues (Focus)
• Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research (Focus)
• Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds (Focus)
• Pharmacquired: Vertex has an appetite for deals. Gene therapy is on the menu (BioPharmaDive)
• Conveying Value of Accelerated Approval Drugs May Be Challenge for Pharma Firms (Healthcare Economist)
• Did a biotech exec crib a New Yorker cartoon? (STAT)
• Has AI Discovered a Drug Now? Guess. (In the Pipeline)
• Establishing Standards for Gene Editing: Initial Steps from Private and Public Actors (Harvard Bill of Health)
• Aclaris to lay off 86 employees in restructuring to extend cash (BioPharmaDive)
• Using MicroRNA to Starve a Tumor? (NIH Director’s Blog)
• Oops! US FDA's Paperwork Submission Failure Leaves Audit Fixes Overdue (Pink Sheet-$)
• FDA Warns Chinese, Costa Rican Drugmakers (Focus)
• FDA Proposes Adding Five New Substances to Pharmacy Compounding List (Focus)
• NIH, Cincinnati Children’s scientists develop potential strategy against leukemia drug resistance (NIH)
• Navigating The Unknown: Practical Thoughts On A Team That Can Rise To The Occasion (LifeSciVC)
• Risks To Avoid When Conducting Virtual Clinical Trials (Law360-$)
• Amgen's Aimovig, under fire from Lilly, loses grip on next-gen migraine share (Fierce)
• Quickfire megarounds tee Passage Bio up for gene therapy trials (Fierce)
• Bausch loses Salix president—and turnaround architect—to precision GI company (Fierce)
• Zafgen hangs for sale sign as chances of imminent recovery fade (Fierce) (Endpoints)
• Johns Hopkins Opens New Center for Psychedelic Research (NYTimes) (Endpoints)
• Achilles Therapeutics raises $120M in Series B round for cancer cell therapy (MedCityNews)
• Quickfire megarounds tee Passage Bio up for gene therapy trials (Fierce)
• Synlogic hires ex-Alnylam VP to lead medical department (Fierce)
• Mylan/Biocon Running Out Of Time To Get Insulin Approved Before US Transition (Pink Sheet-$)
• Table of Pharmacogenomic Biomarkers in Drug Labeling (FDA)

• GBT Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease (Press)
• Breakthrough status for Janssen’s RSV vaccine (PharmaTimes)
• Sage Therapeutics Announces the New England Journal of Medicine Publishes Data from Phase 2 Trial with SAGE-217 in Major Depressive Disorder (Press)
• Deciphera Pharmaceuticals Announces Late-Breaking Oral Presentation of Pivotal Phase 3 INVICTUS Data at the European Society for Medical Oncology (ESMO) 2019 Congress (Press)
• Rocket Pharmaceuticals Announces First Patient Treated in Phase 1/2 Registrational Trial of RP-L201 for LAD-I (Press)
• Ocuphire Pharma Announces Completion of the First of Two Phase 2b Clinical Trials for Nyxol® Eye Drops (Press)

• New Report Compares FDA Quality System Requirements With ISO 13485:2016 (Focus)
• Alphabet and iRhythm are teaming up on tech to detect irregular heart rhythms (CNBC)
• Mevion’s CBCT Imaging Solution from medPhoton Receives FDA Clearance (Press)
• Patent Considerations for Connected Medical Devices (MDDI)
• SF’s Ginger Raises $35M in Burgeoning Digital Therapeutics Market (Xconomy)

• Study: A cap on Medicare drug costs helps a small few — a lot  (STAT)
• Labor union accuses SAMHSA of illegal practices (Politico)
• Proposals to Redesign Medicare Part D — Easing the Burden of Rising Drug Prices (NEJM)
• Medicare Drug-Price Negotiation — Why Now . . . and How (NEJM)
• Former FDA Head Can Testify In Sanofi Hair Loss Trial (Law360-$)
• Gilead Says HIV 'No Generic' Suit Is Baseless (Law360-$)
• Pharma Co. Gets False Ad Suit Over Anesthetic Drug Trimmed (Law360-$)
• Texas sues opioid drug maker, alleging fraud, says it misled doctors (Austin Statesman)
• Another Patient Has Died From Lung Disease After Vaping (NYTimes)
• It’s Only a Minute Order, But Still It Bears Watching (Drug & Device Law)
• The Legal Challenges of the Medicine of Miracles (Harvard Bill of Health)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System (Focus)
• New toolkit to help NHS and industry work together (ABPI)
• GPs alarmed over NHS plans to allow chemists to dispense statins (The Guardian)
• Deal or no deal: Key Brexit-related issues for medical device, IVD sectors (Emergo)
• Novartis cautions that some Lucentis pre-filled syringe plungers may be too stiff (HPRA)

• Second Launch For Rozlytrek, In Japan, But Sales Prospects Limited (Scrip-$)

• NCC-PvPI to join hands with Pharm D institutions for collecting ADR information (PharmaBiz)
• Centre, state sanction Rs. 42.56 crore to Gujarat FDCA to upgrade drug regulatory system (PharmaBiz)

• Tabling of Report on the Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967 (TGA)
• Consultation: Proposed changes to medical device essential principles for safety and performance (TGA)
• Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs (TGA)

• Saudi Arabia medical device market update: MDMA fee increases, new regulations in the works (Emergo)

• Pubic Hair Removal Does Not Raise Sexually Transmitted Infection Risk (NYTimes)