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Recon: GSK Sells Gene Therapy Assets

Posted 12 April 2018 | By Zachary Brennan 

Recon: GSK Sells Gene Therapy Assets

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In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals and Biotechnology
  • 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)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
  • 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)
Medical Devices                                
  • ‘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)
US: Assorted and Government
  • 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 (
  • Medicaid: Opportunities for Improving Program Oversight (GAO)
Upcoming Meetings and Events                Europe
  • 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 ($41 Million USD) Funding (Press)
General Health and Other Interesting Articles
  • A Better Body in a Pill? Experts Urge Caution on SARMs (NY Times-$)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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