Regulatory Focus™ > News Articles > 2019 > 7 > Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dia

Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dialysis, Kidney Transplants

Posted 10 July 2019 | By Michael Mezher 

Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dialysis, Kidney Transplants

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews (Endpoints) (Fierce)
  • 23andMe’s chief scientific officer, a star in drug development, is leaving role (STAT) (Endpoints)
  • DNA-Testing Service Exposed Thousands of Customer Records Online (Bloomberg)
  • CDC made a synthetic Ebola virus to test treatments. It worked (STAT)
  • Top Trump advisers hint at support for progressive proposal to cap drug price hikes (STAT)
  • US aims to cut dialysis in centers, increase transplants by 2025 (Reuters)
  • Trump officials seek plan B on drug pricing rule (The Hill)
  • A Supreme Court ruling may have made it harder to get some info from the FDA (STAT)
  • Trump executive order on organ transplants will fuel a little-known biotech company, Raymond James says (CNBC) (NYTimes)
  • Novartis to sell epinephrine shot in U.S. pharmacies amid EpiPen shortage (Reuters)
  • ICER Lists Potential Topics for Assessments in 2020 (ICER)
In Focus: International
  • Pharmaceutical mergers and megamergers stifle innovation (STAT)
  • GSK's two-drug HIV Dovato treatment meets main goal in study (Reuters) (Endpoints) (Press)
  • Need quick medical advice in Britain? Ask Alexa (Reuters) (PMLive)
  • Pharma industry invests £377m in UK R&D collabs (PharmaTimes)
  • Merck’s Ebola vaccine helps combat deadly outbreak in the Congo as the virus spreads (CNBC)
  • Genmab steps up for a $500M IPO haul, with its sights on a record-setting market cap (Endpoints)
  • Pharma continues to get poor grades when it comes to sharing clinical trial data (STAT)
  • Score! 'Good Pharma' ranking finds uptick in new drug data sharing and clinical trial transparency (Fierce) (Press)
  • Bayer floats animal health merger with Lilly spinoff Elanco: report (Fierce)
  • France will end healthcare refunds for homeopathic drugs (Reuters)
Pharmaceuticals & Biotechnology
  • Charles River plots 2020 opening of South San Francisco lab (Fierce)
  • Supply constraints push EpiPen rival maker Amneal to restructure, shares fall (Endpoints) (BioPharmaDive)
  • KRAS G12C is the hot new play in cancer R&D, and Novartis jumps in with a combo deal (Endpoints) (BioPharmaDive)
  • FDA Finalizes Revised REMS Modifications Guidance (Focus)
  • Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs (Focus)
  • FDA Warns Akorn for Repeat Violations (Focus)
  • Trust, But Verify (AJA Journals)
  • Pharma Money And Physician Prescribing Of Painkillers (Forbes)
  • When Patients Need Opioids to Ease the Pain (NYTimes)
  • New MaPP Fully Outlines Process for FDA Safety Label Changes (Lachman)
  • GSK hires computational drug design expert Dr Kim Branson as new head of machine learning and AI (Pharmafile)
  • Large pharmas set up screening library data-sharing experiment (Nature)
  • Building on bispecifics (Nature)
  • New funding needed for late-stage vaccine work? (Nature)
  • How To Get A Cheaper Prescription Before Leaving The Doctor’s Office (KHN)
  • Watch: High Cost Of Insulin Sends Americans To Canada To Stock Up (KHN)
  • After exiting troubled Merrimack, former CEO becomes new chief at Yumanity (Fierce)
  • Osivax raises €8M for universal flu vaccine clinical trials (Fierce)
  • Sanofi begins countdown for FDA isatuximab review; Cirrhosis-focused biotech presents another mini IPO (Endpoints)
  • New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • FDA accepts BLA filing for Sanofi's rival to J&J's Darzalex  (Fierce) (Press)
  • Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED) (Press)
  • Metavant/Poxel prep phase 3 for imeglimin in diabetic kidney disease (PMLive)
  • Moleculin Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation (Press)
  • FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older (Press)
  • Akebia Therapeutics Announces Collaboration Partner’s Positive Top-line Results of Phase 3 Clinical Study of Riona® (ferric citrate hydrate) in Adult Patients with Iron Deficiency Anemia in Japan (Press)
  • Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection at the American Headache Society’s 61st Annual Scientific Meeting (Press)
  • Ligand Announces Positive Top Line Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol  (Press)
  • Peanut Allergy: Final Evidence Report and Meeting Summary (ICER)
  • Warning Letter - Abington Memorial Hospital, IRC (FDA)
  • Warning Letter - AllerQuest LLC (FDA)
Medical Devices
  • USTR exempts some medical devices from 25% China tariffs (MedtechDive)
  • Medtech VC and the billion-dollar era (Evaluate)
  • AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections (Focus)
  • Medtronic debt offers draw nearly $9B in tenders (MassDevice) (Press)
  • DHS warns on GE Aestiva and Aespire anesthesia devices (MassDevice)
  • ‘Pathways Picks’ July 10: The News this Week (MedTechStrategist)
  • Human factors studies: Considerations for recruiting rare and complex user populations (Emergo)
  • FDA Clears Koios DS™ Breast 2.0 to Assist Physicians with AI-Based Software (Press)
US: Assorted & Government
  • Obamacare on the ropes … again (Politico)
  • U.S. appeals court signals sympathy to bid to strike down Obamacare (Reuters)
  • So You Want to Overturn Obamacare. Here Are Some Things That Would Be Headaches. (NYTimes)
  • Sununu To Sign Bill To Protect Health Coverage for Those With Pre-existing Conditions (NHPR)
  • Okla. Says J&J Addiction Expert Is Just A 'Book Reviewer' (Law360-$)
  • GSK Says Reed Smith Widow Can't Ignore 'Final Judgment' (Law360-$)
  • Bio-Rad's $24M DNA Patent Win Backed By Evidence: Judge (Law360-$)
  • 3rd Circ. Suggests Remicade Fight May Require Arbitration (Law360-$)
  • Rule to Require Drug Prices in TV Ads Found Invalid (FDA Law Blog)
  • Opioid Use Decreased in Medicare Part D, While Medication-Assisted Treatment Increased (HHS OIG)
  • Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019) (Patent Docs)
  • E.D. Missouri Dismisses Non-Missouri Mesh Claims for Lack of Personal Jurisdiction (Drug & Device Law)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Hearing On "Oversight Of Federal Efforts To Combat The Spread Of Illicit Fentanyl" – 16 July 2019
  • Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) – 2 October 2019
  • Federal Listening Session on Interoperability of Medical Devices, Data, and Platforms to Enhance Patient Care – 17 July 2019
  • Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems – 11 July 2019
  • Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes – 11 July 2019
  • EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup (Focus)
  • German, Danish Regulators Explain Dos And Don'ts Of Master Protocols (Pink Sheet-$)
  • New European Commission guidance covers responsible person requirements under MDR, IVDR (Emergo)
  • Healthcare regulators to gain autonomy (PharmaTimes)
  • Biocon founders donate £6 million to Glasgow University for new research hub (Pharmafile)
  • UK Pilot To Generate Real World Data On Medicinal Cannabis Use (Pink Sheet-$)
  • Transgene Receives MHRA Approval for Lead myvac™ Individualized Immunotherapy, TG4050, to Commence Clinical Development in HPV Negative Head and Neck Cancers in the UK (Press)
  • Adaptation of the Guidance document Formal requirements HMV4 (SwissMedic)
  • Astellas Launchs Smyraf Tablets for rheumatoid arthritis in Japan (Press)
  • Chinese drug packaging industry set to be worth RMB200 billion (EPR)
  • USFDA issues 12 observations for three units of Biocon in Malaysia (Business Standard) (BSE)
  • Will India Figure In First-Wave Markets For Sun's Ilumya? (Scrip-$)
  • Updates to variations to prescription medicines guidance and e-form (TGA)
  • Everything you ever wanted to know about sunscreens (but were afraid to ask) (TGA)
Other International
  • WHO Updates Lists of Essential Medicines, Diagnostics (Focus)
General Health & Other Interesting Articles
  • First baby in the U.S. born from transplanted womb of dead donor (NBC)
  • C.D.C. Investigates Rare Type of Paralysis in Children (NYTimes)
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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