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Recon: GE to Spin Off Healthcare Unit; Roivant Slashes Workforce

Posted 26 June 2018 | By Ana Mulero 

Recon: GE to Spin Off Healthcare Unit; Roivant Slashes Workforce

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • BrainStorm will not provide ALS therapy under US Right to Try act (Reuters) (Fierce) (Endpoints)
  • Google’s aging research spinout Calico gets another $1 billion commitment from Alphabet and AbbVie (STAT-$) (CNBC) (Fierce) (Endpoints) (GEN)
  • Spectrum Pharma Is Weighing a Sale (Bloomberg)
  • FDA Repays Industry by Rushing Risky Drugs to Market (ProPublica)
  • GE Will Spin Off Health-Care Business in Latest Revamp (WSJ) (USA Today) (CNBC) (Axios)
  • Roivant cuts staff, reassigns others in major reshuffle, as insider decries 'bloodbath' (Fierce)
  • FDA Hands Achaogen Split Approval and Rejection for Plazomicin (BioSpace) (Reuters)
  • Modified polio vaccine helps fight deadly brain tumors (NBC News) (Reuters) (GEN) (STAT)
  • Bill Haney believes there’s a better way to build a biotech — and now he has $100M more at Skyhawk to prove it (Endpoints)
Sponsored Content: In-Depth IVDR/MDR Kick Starter Kit In Focus: International Pharmaceuticals & Biotechnology
  • Senate Democrats call White House drug prices plan much too thin (Washington Examiner)
  • Sticker Shock: The Real Cost Of America's 10 Most Expensive Drugs (Forbes)
  • Are Orphan Drugs Getting Too Much Attention By Payers And Policymakers? (Forbes)
  • How one lawsuit could upend home medication delivery (Axios)
  • Finding new treatments for Parkinson’s and Alzheimer’s shouldn’t be up to pharma alone (STAT)
  • New drug approval should force the DEA to rethink cannabis-derived medicines (STAT)
  • Walgreens pharmacist refused to fill woman's prescription for miscarriage medication (CNBC)
  • Precision BioSciences bags $110M to take off-the-shelf CAR-T into humans (Fierce)
  • With latest data, has Roche's Tecentriq found a blockbuster lung cancer niche? (Fierce)
  • Forget Tagrisso's $3B sales target. It'll be worth double that by 2023, analyst says (Fierce)
  • Salix sales force to begin promoting Lucemyra in USA (The Pharma Letter)
  • Why be a vaccine company? (BioPharma Dive)
  • Gene and cell therapies are generating investments stampede (BioWorld)
  • As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack (STAT-$)
  • Arcus Biosciences and Infinity Pharmaceuticals Announce Clinical Collaboration to Evaluate Lead Programs in Triple-Combination Studies (Press)
  • Pill May Replace Injection to Deliver Insulin, Other Peptide Drugs (GEN)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA Grants Priority Review Status to Genentech’s Flu Treatments (BioSpace) (MD Magazine)
  • Path for Embattled Breast Cancer Drugs Cleared by One Protein Inhibitor (GEN)
  • With new advances, scientists and drug makers reach for ‘holy grail’ of diabetes treatment (STAT-$)
  • Another Oxycodone Drug Set to Go Before FDA Advisors (MedPage Today)
  • FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA (pembrolizumab) as Adjuvant Therapy in Advanced Melanoma (Press)
  • ITUS Accelerates Schedule for its CAR T Therapy and Provides Update (Press)
  • New Data Presented at the American Diabetes Association 78th Scientific Sessions Reinforce the Potential of The Medicines Company’s inclisiran in Patients with Diabetes (Press)
  • Catabasis Pharmaceuticals Presents New Edasalonexent Clinical Biomarker Data Showing NF-kB Inhibition and Target Engagement in the MoveDMD Trial (Press)
  • aTyr Pharma Announces Positive Phase 1 Data for ATYR1923 Therapeutic Candidate (Press)
  • Recro Pharma Announces Publication of Phase III IV Meloxicam Abdominoplasty Data in Plastic and Reconstructive Surgery Global Open Journal (Press)
Medical Devices
  • Medtronic, Abbott push new diabetes monitoring systems (Minneapolis Star Tribune)
  • Stryker to acquire Swiss surgical smoke firm SafeAir (MassDevice)
  • J&J leads $35m round for sleep-focused neurotech dev Dreem (MassDevice)
  • Reapplix: Positive Outcome Data of Large Randomized Controlled Trial Presented at American Diabetes Association Scientific Sessions (Press)
  • QIAGEN announces broadening of GeneReader NGS System applications into hereditary disease analysis (Press)
  • Xeris Pharmaceuticals Announces Positive Phase 3 Clinical Trial Data on Its Investigational Ready-to-Use Glucagon Rescue Pen (Press)
  • AVITA Medical RECELL Device Pivotal Trial Results in Second-Degree Burns Published in Journal of Burn Care & Research (Press)
  • Zetta's advanced MRI software engine, ZOOM receives FDA 510(k) clearance (Press)
  • New molecular imaging products deliver quantitative accuracy for improved diagnoses (Press)
US: Assorted & Government
  • New CDC Director Targets Opioids, Suicide and Pandemics (WSJ)
  • Sky-High Deductibles Broke the U.S. Health Insurance System (Bloomberg)
  • White House’s Reorganization Plan Would Make For A Leaner, Better FDA (The Federalist)
  • Nevada Department of Health and Human Services to Exercise Enforcement Discretion for Required Reports under Drug Pricing Transparency Law (FDA Law Blog)
  • Maine may not wait for Congress to pass a law to boost generic drug development (STAT-$)
  • Supreme court blocks California law on anti-abortion centers (Reuters)
  • Why Retailers Are Installing Blue Lights In Bathrooms to Discourage Drug Use (Fortune)
  • Big Business Coalitions To Form National Value-Based Payment Network (Forbes)
  • Patient matching will lead to interoperability, Pew says (Healthcare IT News)
  • AHA ‘strongly opposes’ interoperability as a Medicare requirement (Fierce)
  • Advancing a Nationwide Patient Matching Strategy (AHIMA)
  • The Food and Drug Administration’s Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments (FDA)
  • Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OIG)
  • UPMC and Pitt Launch Genome Center to Advance Precision Medicine and Immunotherapy (UPMC)
Upcoming Meetings & Events Europe
  • Update: Astellas UK (ABPI)
  • The Role of Post-market Surveillance in the European Medical Devices Regulation (MDR): Key Questions (Emergo Group)
  • MDR and IVDR Update: Publication of Labels and Instructions for Use on Manufacturers’ Websites (Emergo Group)
  • Pride and worry, Britain's free health service turns 70 (Reuters)
  • UK researchers develop medical patch to treat mucosal conditions (Verdict Medical Devices)
  • Survey reveals women experience severe reproductive health issues (Public Health England)
  • Communicable diseases: Commission updates surveillance list (EC)
  • Life sciences sector focus for UK-US event (UK Government)
  • MeiraGTx Receives Positive Opinion for Orphan Drug Designation in the European Union for AAV-CNGA3 for the Treatment of Achromatopsia (Press)
  • Keep Blueprints 'At Home' When Partnering With Chinese Pharma Companies, Advises India (The Wire)
  • China reports highly pathogenic H5N1 bird flu at chicken farm: OIE (Reuters)
  • Il-yang’s antianginal drug found with excessive lead (Korea Biomedical Review)
  • STAAR Surgical and Kobe Kanagawa Eye Clinic in Japan Announce Strategic Cooperation Agreement (Press)
  • Agios and CStone Pharmaceuticals Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Ivosidenib in Greater China (Press)
  • Russia’s Tyumen keen on hosting Indian pharma ventures (The Hindu)
  • Cost recovery implementation statement (TGA)
  • Updates to the Prescribing Medicines in Pregnancy database (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Drug resistance: Is Canada ready for the climate change of human health? (The Canadian Press)
  • Cost of substance use in Canada tops $38 billion, with booze and tobacco on top (The Canadian Press)
General Health & Other Interesting Articles
  • The Neuroscience of Pain (The New Yorker)
  • The next big thing in data storage is actually microscopic (The Boston Globe) (Wired)
  • The latest blood pressure guidelines: What they mean for you (The Conversation)
  • Studies Identify Key Genes for Intelligence, Depression, ADHD, and Autism (Fortune)
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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