Recon: GSK Sells Gene Therapy Assets

• The FDA Breakthrough-Drug Designation — Four Years of Experience (NEJM-$) (Stat-$) (Endpoints)
• Breakthrough-Therapy Designation — An FDA Perspective (NEJM)
• FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research (KHN)
• FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems (FDA) (MedGadget)
• Bill Gates: Gene editing for good (Foreign Affairs)
• Why We May Lose Generic Drugs (Bloomberg)
• Bellicum shares surge as FDA lifts a clinical hold on lead cell therapy following a protocol adjustment (Endpoints)
• FDA relaxes clinical hold on Translate Bio’s cystic fibrosis drug (Fierce)
• Biosimilar AMA With FDA’s Leah Christl (Reddit)
• Novartis CEO: How To Create Cheaper Alternatives To The Most Expensive Drugs (Forbes)

• GSK hands off its rare disease unit to Orchard Therapeutics (Endpoints) (Reuters) (Xconomy)
• In Caracas, Sick Humans Are Resorting to Dog Medicine (Bloomberg)
• WHO and UNICEF issue new guidance to promote breastfeeding in health facilities globally (WHO)
• China to remove tariffs on imported cancer drugs from May 1: state media (Reuters)
• Despite high hopes for polio eradication, discouraging news is piling up (Stat)
• Healthcare: Cancer breakthrough leads China’s biotech boom (FT-$)
• Educational materials and associated distribution plans (MHRA)

• CRISPR trials are about to begin in people—but we still don’t know how well it works in monkeys (MIT Tech Review)
• Non-profit’s $300 hepatitis C cure as effective as $84,000 alternative (Guardian) (Pharmafile)
• Can CAR-T and gene therapy cures really sustain biopharma? Not for all, analyst says (Fierce)
• As cancer drug prices climb, value not keeping pace (Reuters)
• Mylan bets future on complex generics (BioPharma Dive) (Scrip-$)
• Abpro files $69M IPO to take bispecific antibodies into the clinic (Fierce)
• Pfizer pulls plug on Inlyta trial (PharmaTimes)
• Biotech M&A is ripping along now as IPOs surge and venture cash flows. Who’s the next big target? (Endpoints)
• Amgen goes back to Rhode Island to build its first next-gen manufacturing site in the US (Endpoints)
• Catalent completes expansion (Outsourcing-Pharma)
• Sanofi to build 350 million-euro vaccine unit in Canada (PharmaLetter-$)
• PCSK9s appear to be meeting less payer resistance (BioPharmaDive)
• Purdue Pharma L.P. Names Dr. John Renger as Vice President, Head of Research & Development and Regulatory Affairs (Press)

• Delays in the Publication of Important Clinical Trial Findings in Oncology (JAMA)
• T cell–induced CSF1 promotes melanoma resistance to PD1 blockade (Science-$)
• Personalized cancer vaccine effectively mobilizes antitumor T cell immunity in ovarian cancer (Science-$)
• Despite Pain Drug’s Mid-Stage Miss, Adynxx Plans a Larger Phase 3 Test (Xconomy)
• Zika Virus Shedding in Semen of Symptomatic Infected Men (NEJM) (CBS News)
• A new, personalized vaccine is targeting the deadliest cancers in America (CNBC)
• Translate Bio Announces FDA Clearance to Proceed with Phase 1/2 Clinical Trial in Patients with Cystic Fibrosis (Press)
• Bristol-Myers Squibb and Harvard Announce New Fibrosis Research Collaboration (Press)
• Pfizer Doses First Patient Using Investigational Mini-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy (Press)

• ‘Therabros’ and ‘disappeared’ staffers: the 8 juiciest things we learned from John Carreyrou’s new Theranos book (Stat)
• EyeGate Non-Invasive System Uses Electricity To Pull Drug Into Eye (MedGadget)
• Innovus Pharma wins FDA nod for glucose monitoring kit (MassDevice) (Press)
• Neovasc raises $7m in warrants offering (MassDevice)

• While Greater Attention Given to Combating Synthetic Opioids, Agencies Need to Better Assess their Efforts (GAO)
• Ironed Out (FDA Voice Blog)
• Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration (Federal Register)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products (Federal Register)
• Hank Tomlinson Named New Director for CDC’s Division of Global HIV & TB (HIV.gov)
• Medicaid: Opportunities for Improving Program Oversight (GAO)

• RAPS' FDA Advisory Committee Meeting Tracker

• HeartStitch wins CE Mark for Trans-Apical Access and Closure device (MassDevice)
• Emergent BioSolutions Announces Successful Completion of Mutual Recognition Procedure for Market Authorisation of BioThrax in European Countries (Press)
• Enterprise Therapeutics Raises £29 Million ($41 Million USD) Funding (Press)

• A Better Body in a Pill? Experts Urge Caution on SARMs (NY Times-$)