Regulatory Focus™ > News Articles > 2019 > 8 > Recon: Two Promising Drugs Emerge in Congo Ebola Trial; NHS Scotland Denies CF Drugs

Recon: Two Promising Drugs Emerge in Congo Ebola Trial; NHS Scotland Denies CF Drugs

Posted 12 August 2019 | By Michael Mezher 

Recon: Two Promising Drugs Emerge in Congo Ebola Trial; NHS Scotland Denies CF Drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biotech faces a crisis in credibility fueled by boom-era hubris (STAT)
  • US patients struggle to obtain Eli Lilly’s half-price insulin (Financial Times)
  • These health-tech veterans want to avert the next Theranos disaster with ‘medical diligence’ (CNBC)
  • Deals Give Drugmakers Rights to DNA Data (WSJ)
  • Drug Shortage Leaves Patients Without Immune-Disorder Treatment (WSJ)
  • Drugmakers Put Bad Spin on a Bizarre Week (Washington Post)
  • US records 10 new cases of measles last week (Reuters)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • Two New Ebola Treatments Prove Highly Effective in Congo Epidemic (NYTimes) (Reuters) (STAT) (NIH)
  • Regeneron's Ebola treatment proves superior to rival in trial (Reuters) (Press)
  • WHO says no new Ebola cases in Goma, vaccinates over 1,300 (Reuters)
  • Drug maker 'will make $21bn from treating cystic fibrosis' (The Guardian)
  • Cystic fibrosis drugs rejected for use by NHS in Scotland (The Guardian) (NHS Scotland 1, 2)
  • Novartis benefits from faster China drug approvals (Financial Times)
  • Details of Canada's biggest drug pricing overhaul in decades (Reuters)
  • No-deal Brexit could deepen Europe's shortage of medicines – experts (Reuters) (Pharmafile)
  • Novo Nordisk boosted by new type 2 diabetes launches (PMLive)
  • Dengue death toll rises in Malaysia, number of cases close to double (Reuters)
  • For rules on creating ‘CRISPR babies’ from edited embryos, scientists call a do-over (STAT)
  • Canadians are hopping mad about Trump’s drug importation plan. Some of them are trying to stop it. (STAT)
Pharmaceuticals & Biotechnology
  • Sarepta’s bad week raised questions about its gene therapy program. Here are some answers (STAT)
  • 5 Big Pharma Showdowns to Watch (Barrons)
  • A top analyst spotlights a wave of biotech startups looking to catapult onto Nasdaq — or get bought out (Endpoints)
  • Pharmaceutical groups should invest in public health systems (Financial Times)
  • KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process (IPQ)
  • Continuous Manufacturing in Pharmaceuticals: Implications for the Generics Market, 2017-2024 - ResearchAndMarkets.com (Press)
  • GSK poaches Merck KGaA exec to replace departing U.S. pharma president Bailey (Fierce) (Endpoints)
  • How does TDP-43 bog up the brains of ALS, FTLD patients? AC Immune enlists Penn scientists to find out (Endpoints)
  • Progressive multiple sclerosis: from pathophysiology to therapeutic strategies (Nature)
  • Brammer Bio to set up new plant in Norton, Massachusetts (Pharmafile)
  • BridgeBio CEO Neil Kumar engineers a deal to reel back Eidos shares. Or is he really hunting a buyout? (Endpoints)
  • Boehringer follows the popular KRAS trail to MD Anderson — inks new alliance on 'virtual' research center (Endpoints)
  • Sonnet bags ex-Serono neuropathy drug via Relief Therapeutics deal (Fierce)
  • Analysts track doubling in number of private biotech rounds (Fierce)
  • Antiretroviral Therapy's Positive Impact On Global Public Health Faces Challenges Moving Forward (Forbes)
  • Texas almost mandated an HPV vaccine before politics got in the way. Now, the state has one of the country's highest rates of cervical cancer. (Texas Tribune)
  • Regulatory, manufacturing setbacks hit several biopharma companies (MedCity)
  • Determination That LEVITRA (Vardenafil Hydrochloride) Tablets, 2.5 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • PolyPid Completes Enrollment of Phase 2 Clinical Trial with D-PLEX100 in Abdominal Surgery (Press)
  • Kedrion Biopharma Announces First Patient Enrolled in CARES10, a Phase 3, Multi-Center Study to Assess a 10 Percent Intravenous Immunoglobulin in Adults with Primary Immunodeficiency Disease (Press)
  • Ancora Heart Enrolls First Patient in European Multi-Center Study of First-of-Its-Kind Investigational Heart Failure Therapy (Press)
Medical Devices
  • Endologix Takes a Step Forward with Nellix IDE (MDDI)
  • Massive Teleflex endotracheal tube recall extends to Centurion Medical Products (MassDevice)
  • FDA Clears Binx Health Point-of-Care Testing Platform for Chlamydia and Gonorrhea (Genome Web)
US: Assorted & Government
  • Court OKs $65.8M Deal In Cephalon Pay-For-Delay Suit (Law360-$) (Fierce)
  • Illinois Law Requiring Sesame Labeling to Spark a National Trend? (FDA Law Blog)
  • Humana takes aim at Mallinckrodt's 'ill-gotten' Acthar gains in lawsuit (Endpoints)
  • US appeals court rules Dr Reddy’s infringes Lilly's Alimta patent (PharmaLetter-$)
  • Amgen Inc. v. Coherus BioSciences Inc. (Fed. Cir. 2019) (Patent Docs)
  • Prescription Medical Product Causation – Expert Required – Part One (Drug & Device Law)
  • Athenex Ruling Helps Clarify FDA Drug Compounding Policy (Law360-$)
Upcoming Meetings & Events Europe
  • Blue Guide: advertising and promoting medicines (MHRA)
  • Monitoring of consumption and biosimilar spending (AIFA)
Asia
  • Preferential tax policies coming for biopharmas setting up shop in Shanghai's newest free trade zone (Endpoints)
  • NMPA issues notice on publicity and implementation of Vaccine Administration Law (NMPA)
  • China National Medical Products Administration Grants Innovative Medical Device Designation for Optune® in China (Press)
  • New Shanghai clinical research center opened by Ascletis (PharmaLetter-$)
India
  • Facing headwinds in US, Natco Pharma looks to scale up business in China (Economic Times) (Fierce)
  • Unichem Laboratories gets USFDA nod for hypertension management drug (Economic Times)
  • CDSCO rolls out pan-India workshops to equip manufacturers on data requirements for drug product approval (Pharmabiz)
  • Bombay HC dismisses PIL filed against online sale of Schedule H and Schedule X drugs (Pharmabiz)
  • Indian Pharma Market registers 13.2 per cent growth in July 2019 (Pharmabiz)
  • MvPI reports 1,213 medical devices adverse event reports from across country since 2014 (Pharmabiz)
  • Key priority is to drive further growth in chronic portfolio: Cipla (Pharmabiz)
Australia
  • Paclitaxel-coated products used in the peripheral arteries (TGA)
Other International
  • New measles surveillance data from WHO (WHO)
  • 42nd Expert Committee on Drug Dependence (ECDD) 21 to 25 October 2019, WHO Headquarters, Geneva Switzerland Substances under review (WHO)
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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