Regulatory Focus™ > News Articles > 7 > Recon: 23andMe Gets $300M Boost From GlaxoSmithKline

Recon: 23andMe Gets $300M Boost From GlaxoSmithKline

Posted 25 July 2018 | By Ana Mulero 

Recon: 23andMe Gets $300M Boost From GlaxoSmithKline

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

In Focus: US In Focus: International
  • Top EU court: GMO rules cover plant gene editing technique (Reuters) (The Guardian)
  • Vaccine scandals taint Beijing's ambition to become a global pharmaceutical powerhouse (CNBC)
  • Hong Kong clinics prepare for influx of mainland visitors after China vaccine scandal (Reuters)
  • Multi-disease health fairs, universal “test and treat” help East African communities achieve HIV benchmarks (NIH)
  • The HPRA is pleased to announce that we are transitioning to a new human medicines electronic workflow system (HPRA)
Pharmaceuticals & Biotechnology
  • Gilead's Truvada for PrEP can reduce HIV rates, but activists decry unequal access (Fierce) (AP News) (MedPage Today)
  • Déjà Voodoo: Pharma’s Promises To Curb Drug Prices Have Been Heard Before (KHN)
  • RxLegal: A Rapid Review of Right-To-Try. (PubMed)
  • Scientist Invented A New Pathway To Approve Biosimilars - And The FDA Is Listening (Forbes)
  • AbbVie prices new endometriosis drug at $10,000 a year (Reuters)
  • U.S. to narrow opioid bribe case against Insys founder, others (Reuters)
  • Paying for therapies that cure: innovative solutions needed (STAT)
  • Prescription apps are gaining ground — and drug makers’ backing — as digital therapeutics (STAT-$)
  • Activists want the NIH to break patents on a Gilead drug for preventing HIV (STAT-$)
  • Illinois Law Expands Ban on Discharging Unused Medicines (Bloomberg-$)
  • Shareholder Accuses Acadia of Hiding Nuplazid Safety Issues (Bloomberg-$)
  • Zavante CEO sells his late-stage antibiotic biotech to Nabriva — grabbing the helm in the deal (Endpoints)
  • bluebird bio to raise $550 million through public offering (The Pharma Letter)
  • Valsartan products not recalled as of July 24, 2018 (FDA)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological ProductS (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Two Drugs as Good as Three for Treating HIV (Labiotech) (PharmaTimes) (Pharmabiz)
  • Can gene therapy halt diseases in babies before they’re even born? (STAT)
  • Takeda R&D team rings the blockbuster bell with key PhIII success in frontline lung cancer (Endpoints)
  • Janssen Presents Switch Data for New HIV-1 Treatment SYMTUZA (D/C/F/TAF) and Second Study Supporting its Use in a Rapid Initiation Scenario (Press)
  • First Long-term Immune Response Data for Investigational HIV-1 Preventive Vaccine Announced by Johnson & Johnson (Press)
  • Corium Presents Additional Positive Clinical Results at Alzheimer's Association International Conference 2018 (Press)
  • Eisai and Biogen Present Detailed Results From Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2018 (Press)
Medical Devices
  • Stryker Beats Earnings Estimates, Barely Beats Revenue Estimates (Forbes)
  • Nevro shares plunge, rebound on court ruling in Boston Scientific spa (MassDevice)
  • Boston Scientific beats 2Q earnings expectations (Minneapolis Star Tribune)
  • Healthy.io gets FDA nod for smartphone camera-based home urine test (MobiHealthNews)
  • Bayer Essure Suits Skyrocketed as FDA Pushed Stronger Warnings (Bloomberg-$)
  • 3-D Color X-Rays Could Help Spot Deadly Disease Without Surgery (NYT)
  • The Bleeding Edge: Netflix medical devices documentary is terrifying (The Guardian)
  • Houston medical device startup hires former Abbott exec as CEO (Houston Business Journal-$)
  • UMB-born medical device startup raises $2.35 million, moves toward FDA clearance (Baltimore Business Journal-$)
  • Siemens Healthineers Transforms Care Delivery with Innovative New Tests for Diagnosing Heart Attacks Faster (Press)
  • Abbott Introduces Breakthrough Point-of-Care Test, the m-PIMA HIV-1/2 Viral Load (VL), at AIDS 2018 Amsterdam (Press)
  • First ischemic stroke patients treated with EMBOTRAP II revascularization device since commercial availability in US (Press)
US: Assorted & Government
  • Ex-Apple Health director is now working to fix medical records (CNBC)
  • Medical Records’ Dirty Data Hinder AI’s Role in Research (Bloomberg-$)
  • Blockchains for biomedicine and health care are coming. Buyer: be informed (STAT)
  • Democrats take aim at high drug prices with bill allowing Medicare to negotiate (STAT-$)
  • Fauci: HIV remission free of antiretroviral therapy is a feasible goal (NIH)
  • Anthem's Focus On Medicare Over Obamacare Boosts Profits (Forbes)
  • Centene Won't Gobble Doctors Like Other Insurers (Forbes)
Upcoming Meetings & Events Europe
  • UK Aid raises the voices of grassroots HIV organisations (Gov UK)
  • IT systems unavailable from 27 to 30 July 2018: EMA website and online applications will be temporarily unavailable (EMA)
  • Fertility treatment doesn't boost overall risk of breast, ovary or uterus cancers (Reuters)
  • Opioid analgesics, Z-drugs linked to harmful effects in dementia patients (PharmaTimes)
  • Biosimilar switches and healthcare gains (pharmaphorum)
  • Rhythm Pharma gets European PRIME designation for setmelanotide in rare genetic disorders of obesity (Pharmabiz)
  • Janssen mulls legal proceedings against Russia’s Pharmsyntez (The Pharma Letter-$)
  • Omeros’ OMS721 Receives European Orphan Drug Designation Positive Opinion for Treatment in Hematopoietic Stem Cell Transplantation (Press)
Asia India
  • Even after 10 months, Maharashtra govt still waiting for lab survey report to initiate action against illegal labs (Pharmabiz)
Australia
  • Police can access My Health Record without court order, parliamentary library warns (The Guardian)
  • 'False and reckless': Health Minister slams anti-vaccination documentary maker (The Sydney Morning Herald)
Canada
  • N.B. gov't may launch lawsuit over opioid crisis (The Canadian Press)
  • Baxter Announces Health Canada Approval of Spectrum IQ Infusion System (Press)
General Health & Other Interesting Articles
  • Study: Lowering blood pressure helps prevent mental decline (AP News)
  • IBM’s Watson supercomputer recommended ‘unsafe and incorrect’ cancer treatments, internal documents show (STAT-$)
  • Mobile App Will Transform Data Entry And Collection In Clinical Studies, Company Says (Forbes)
  • Want to reach smartphone-happy doctors? Hint: Typical mobile marketing won't work (Fierce)
  • The Next Cancer Drug Might Start in Outer Space (Bloomberg-$)
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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