Recon: FDA Expands J&J's Darzalex for Multiple Myeloma; UK Agency Finds Gaps in No-Deal Brexit Prep

• How impeachment push is shaking up health agenda (Politico) (Axios)
• US judge refuses to disqualify himself from opioid litigation (Reuters)
• FDA OKs expanded use of AbbVie's Mavyret (Seeking Alpha) (FDA) (Press)
• J&J’s Darzalex makes FDA history with another myeloma nod in new patients (Fierce) (Press)
• Jazz gets its narcolepsy upgrade drug decked out for the FDA as clock ticks down on cash cow patents (Endpoints) (PharmaTimes)
• India's Strides Pharma halts US sales of heartburn drug (Reuters) (Economic Times)
• Is the FTC about to force Roche to divest a key hemophilia program before green-lighting Spark buyout? (Endpoints)
• CDC Says The Cause Of Vaping Related Deaths Is Still A Mystery (NPR)
• US vaping-related deaths rise to 12, illnesses climb to 805 (Reuters)
• US House panel asks e-cigarette companies to cease advertising (Reuters)

• Brexit may have 'gravest of consequences' for health: UK lawmaker (Reuters)
• Significant gaps remain in UK’s no-deal Brexit prep, says NAO report (PMLive)
• Many Firms Still Not Ready For No-Deal Brexit, Says UK BIA (Pink Sheet-$)
• Pfizer UK removes sales incentives for anti-infectives (PharmaTimes)
• Shiny, new and expensive: ESMO studies find new cancer drugs carry higher prices, add little benefit (Fierce)
• Biocon to reduce insulin prices to 10 cents per day (Economic Times)
• GSK, AstraZeneca rivalry takes center stage at cancer conference (Reuters)
• Takeda Is Close to Selling Emerging Market, European Drugs (Bloomberg) (Endpoints)
• Change of name of liposomal medicines at high risk of medication errors (EMA)
• PIC/S Proposes Specific GMP Annex For Advanced Therapies (Pink Sheet-$)
• Health ministers to gather in Washington to set policies, priorities for health action in the Americas (PAHO)

• Generic Zantac is recalled from major U.S. pharmacies after carcinogen is found in pills (LA Times)
• Nobel Laureate: Docs Must Insist on Evidence in Medicine (Medpage)
• Deep impact: Drugs to watch in Q3 — PBM analysis (Endpoints)
• Oncologists listen when the FDA speaks, even after a drug hits the market (Endpoints)
• GSK to spend $120M on new manufacturing hub for drug pipeline (BioPharmaDive)
• Endo’s Opana IR Should Not Add Pediatric Data To Labeling, US FDA Panel Says (Pink Sheet-$)
• Childhood cancer patients' stem cells destroyed after freezer malfunction (NBC)
• Teens may struggle to get opioid overdose drug at U.S. pharmacies (Reuters)
• Cannabis research pioneer hopes latest discovery is not overlooked — again (NBC)
• Body-on-a-Chip Device Predicts Cancer Drug Responses (NIH)
• Could pharma, digital therapeutics partnerships be a $1B opportunity? (MedCity)
• Drug R&D report questions public return on investment (PharmaLetter-$)
• New NIH program provides comprehensive treatment for inherited blood and immune diseases (NIH)
• Lack of awareness of Chagas disease in the US leading to unnecessary deaths in vulnerable immigrant communities (DNDi)
• 20-year GSK veteran takes up CSO role at metabolic startup HemoShear (Fierce)
• Meissa raises $30M to take RSV vaccine into the clinic (Fierce)
• Prospective Grant of Exclusive Patent License: Capsid-Free AAV Vectors, Compositions, and Methods for Vector Production and Gene Delivery (NIH)

• Ipsen Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy (Press)
• A microcap biotech salves old wounds with positive PhII report on status epilepticus, but plenty of questions remain (Endpoints)
• Innate Pharma and AstraZeneca take monalizumab into phase 3 (Press)
• Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis (NEJM)
• Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical Oncology (ESMO) 2019 Congress (Press)
• Arena Pharmaceuticals Presented New Data from the Phase 2 OASIS trial for Etrasimod at the World Congress of Gastroenterology Meeting (Press)
• Noveome Biotherapeutics, Inc. Initiates Phase 1 Open Label Clinical Trial Evaluating Intranasal Delivery of Lead Candidate ST266 Targeting the Optic Nerve and Brain (Press)
• BRILINTA Monotherapy in High-Bleeding Risk Patients Who Underwent PCI had Reduced Risk of Clinically Relevant Bleeding Than With Dual Antiplatelet Therapy in the TWILIGHT Trial (Press)
• Curevo Vaccine Announces Interim Results of Phase I Clinical Trial of CRV-101 (Press)

• Illumina, maker of DNA sequencing machines, had a small round of layoffs in September (CNBC)
• Becton Dickinson, Zoll win DoD contracts (MassDevice)
• Patients Know Best: FDA Releases Draft Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations (FDA Law Blog)
  Traditional devicemakers struggle in fast-growing ambulatory market (Modern Healthcare)
• Aurora Concussion Therapy Systems wins breakthrough nod from FDA (MassDevice)
• Medtronic announces Infuse spine trial (MassDevice)
• FDA Approves Abbott's 'Low Dose' Neurostimulation Device for Chronic Pain (MDDI)
• FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers (Press)

• The Role of Attorneys General in the Opioid Litigation (Harvard Bill of Health)
• Report: Opioids settlement won’t fix areas hardest hit (AP)
• Intra-Cellular Therapies, Inc. v. Iancu (Fed. Cir. 2019) (Patent Docs)
• NIH funds $945 million in research to tackle the national opioid crisis through NIH HEAL Initiative (NIH)

• FDA Advisory Committee Calendar

• Stoller Sets Agenda As Medicines For Europe’s President (Pink Sheet-$)
• Cell and Gene Therapy Catapult doubles capacity at UK site (Pharmafile)
• Dutch prosecutors seek Supreme Court ruling on euthanasia for incapacitated patients (Reuters)
• Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)
• Industry shoots down Labour's plans to tackle 'extortionate' drug prices (PharmaTimes) (Pharmaceutical Journal)
• Sunset clause: request for public health exemption (MHRA)
• Contact lenses recall: 1-day Acuvue Moist for Astigmatism - MHRA urges patients to check their boxes for recalled lots (MHRA)
• Applying for a Certificate of Pharmaceutical Product after Brexit (MHRA)
• Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letters to industry (MHRA)
• Gov't pledges overhaul of cancer screening (PharmaBiz)

• Strides Pharma Science arm gets USFDA nod for drug to treat overactive bladder (Economic Times)
• Growing Indian pharma market needs more investment (PharmaLetter-$)

• Consultation: Review of the regulation of certain self-testing IVDs in Australia (TGA)

• TGA business plan 2019-20 (TGA)
• These Ants Use Germ-Killers, and They’re Better Than Ours (NYTimes)