Recon: GSK Ends Ebola Vaccine Development, Transfers Vaccine Candidates to Sabin Institute

• 2020 election creates ‘perfect storm’ for drug price reform by year-end (CNBC)
• Deadly Germ Research Is Shut Down at Army Lab Over Safety Concerns (NYTimes)
• Diabetes drug maker Novo Nordisk buys pill factory in North Carolina (Reuters)
• Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny (STAT)
• Help how? Patient charities favor the insured and more expensive brand-name drugs (STAT)
• Medicare finalizes CAR-T changes, tables more dramatic moves (Politico) (STAT)
• Bluebird raises questions by sitting on results of CAR-T drug critical to its future (STAT)
• These devices are inserted into 500k patients each year — but are tough to sterilize (NYTimes)
• Gilead faces a hurdle in its race for big, add-on OK for Descovy as Truvada generics loom (Endpoints)
• In reversal, Mallinckrodt puts split plans on hold (BioPharmaDive) (Endpoints)
• FTC Concerns Over Bristol-Myers Deal Raise Questions (Law360-$)

• GSK ends development of Ebola vaccine, hands work to US institute (Reuters) (Fierce) (STAT) (Endpoints) (Press)
• EU approves Sanofi, Regeneron's Dupixent for adolescent eczema cases (Reuters) (Press)
• Philippines Declares a National Dengue Epidemic (NYTimes)
• Ugandan says starts its largest-ever Ebola vaccine trial (Reuters)
• Ebola outbreak in east Congo's main city tests flexibility of response (Reuters)
• NICE reject Clovis Oncology's ovarian cancer drug Rubraca (Pharmafile) (Endpoints)
• International Regulators Call for Action on Antimicrobial Resistance (Focus)

• Statins Provide Heart Benefits Past Age 75 (NYTimes)
• The search for a dementia cure rests on helping innovators (Financial Times)
• Regeneron's Sanofi deal finally turns a profit, thanks to Dupixent (Fierce)
• AbbVie files blockbuster hopeful elagolix for uterine fibroids (PMLive)
• FDA Opioid Packaging Proposal: Experts Seek Proof of Concept (Focus)
• Biotech startup joins quest to harness microbiome to untether reliance on antibiotics in women's health (Endpoints)
• Neoleukin's quest to shake up the IL-2 space gets a boost via reverse merger with Aquinox (Endpoints)
• FDA Obscura: GDUFA Fee Calculations Took CBER-Regulated ANDAs Into Account (Pink Sheet-$)
• US FDA Inspection In Store? Here Are Some Areas That May Be On Agency’s Radar (Pink Sheet-$)
• FDA endorses Novavax's pivotal trial design for flu vaccine; Forty Seven bags funding for myelodysplastic syndromes program (Endpoints)
• Lilly's Emgality smashes all Phase 3 endpoints in migraine sub-population (Pharmafile)
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays (FDA)
• The Search for an Easier Way to Stop Taking Sleeping Pills (WSJ)
• Amneal founders take reins as business struggles mount (BioPharmaDive)
• Generic companies acting as CMOs for global pharma in Middle East (PharmaLetter-$)
• Ribon hires CMO as lead PARP drug nears clinical trials (Fierce)

• Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms (Press)
• Dupixent® (dupilumab) showed positive topline results in Phase 3 trial of children aged 6 to 11 years with severe atopic dermatitis (Press)
• Alnylam Announces U.S. Food and Drug Administration (FDA) Granted Priority Review of the Givosiran New Drug Application (NDA) for the Treatment of Acute Hepatic Porphyria (Press)
• Inotrem Announces FDA Clearance of Investigational New Drug (IND) for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy (Press)

• US FDA medical device user fees increase six percent for 2020 (Emergo)
• Guardant data another step forward for tissue-agnostic diagnostics (BioCentury)
• A Chance To Clarify Medical Device Patent Indefiniteness (Law360-$)
• FDA slaps Abbott ICD recall with Class I label (MassDevice)
• Brazil regulators require electronic submission of medical device FSCAs (MassDevice)
• Cardiovascular Systems acquires Gardia Medical’s embolic protection system (MassDevice)
• FDA approves Endotronix trial for Cordella PA pressure sensor (MassDevice)

• Advocates pan Trump on call to link mental health, mass shootings (Politico) (CNBC)
• Minnesota lawsuit takes aim at Sackler family’s alleged role in opioid crisis (TwinCities)
• Timetable For Opioid MDL Trial 'Entirely Untenable': Drug Cos. (Law360-$)
• Ex-FDA Czar Says J&J Mesh Paperwork Left Out Risk Info (Law360-$)
• Is Timing Right For An Anthem-HCSC Blue Cross Mega Merger? (Forbes)
• Preemption Highlights (Drug & Device Law)
• Celgene Corp. v. Peter (Fed. Cir. 2019) (Patent Docs)
• A “Big” Bulks Decision for Outsourcing Facilities and Athenex: Court Affirms FDA’s Method of Determining “Clinical Need” in a Resounding Blow for Outsourcing Facilities (FDA Law Blog)

• FDA Advisory Committee Calendar

• EMA Clarifies Requirements for Peptones Used in Active Substance Manufacturing (Focus)
• Spanish officials yank Novocat's GMP certification after inspectors turn up serious shortfalls (Fierce)

• Asia Regulatory Roundup: China Expands Medical Device Registration Pilot to Cover Multiple Regions (Focus)

• Man fined for alleged importation and advertising of unapproved therapeutic goods (TGA)
• Mylan-Biocon’s Ogivri First Off Block In Australia But Competition In Sight (Scrip-$)

• Canada Consults On Customized Rules For Approving Unique Drugs, Devices (Pink Sheet-$)
• Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the ICH of Technical Requirements for Pharmaceuticals for Human Use Guidelines Update (Health Canada)