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

• 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)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• 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)

• 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)

• 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)

• 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)

• 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-$)
• Amgen Inc. v. Coherus BioSciences Inc. (Fed. Cir. 2019) (Patent Docs)
• Prescription Medical Product Causation – Expert Required – Part One (Drug & Device Law)
• Athenex Ruling Helps Clarify FDA Drug Compounding Policy (Law360-$)

• FDA Advisory Committee Calendar

• Blue Guide: advertising and promoting medicines (MHRA)
• Monitoring of consumption and biosimilar spending (AIFA)

• 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-$)

• 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)

• Paclitaxel-coated products used in the peripheral arteries (TGA)

• 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)