Recon: Sarepta Rival Submits DMD Drug to FDA

• Trump says Pelosi's promise to work with him on drug price plan is 'camouflage' for impeachment (CNBC) (AP)
• Affordability Boards — The States’ New Fix for Drug Pricing (NEJM)
• Sarepta rival NS Pharma files Duchenne drug with FDA (PMLive) (STAT)
• FDA Warns Against Certain Methods for Testing Zantac for Carcinogen (Focus) (Reuters)
• Walmart becomes latest US retailer to pull heartburn drug Zantac (Reuters)
• Lilly, Bayer dodge whistleblower suits as judge follows DOJ's lead (Fierce) (STAT)
• After much fanfare, Civica Rx delivers its 1st drugs (BioPhamraDive)
• ICER pulls report blasting ‘marginal’ RA drugs, says must rethink approach (Fierce) (Endpoints) (ICER)
• UPS Gets FAA Nod for Widespread Drone Deliveries of Health Supplies (WSJ) (AP)
• Lung Damage From Vaping Resembles Chemical Burns, Report Says (NYTimes)

• UK Biotech Fundraising Shrinks In Q3 As Brexit Looms (Scrip-$)
• Philippines polio cases a warning for vulnerable Ukraine (Reuters)
• Japan drug price reforms risk hurting investment: Bristol-Myers CEO (Reuters)
• Mutant viruses are threatening the polio eradication effort (Politico)
• Adicet Bio raises $80 million to develop cancer cell therapies (Reuters)
• NICE turns down Roche’s Tecentriq for triple-negative breast cancer (PMLive)
• Novartis’ Cosentyx scores again in phase 3, strengthens approval claim (PMLive)
• When Can RWE Translate Into Credible Evidence? EMA Officials Discuss (Focus)
• IMDRF Offers New Guidance on Cybersecurity (Focus)
• Having cut Teva’s manufacturing headcount by thousands, Carlo de Notaristefani will retire (Fierce)

• Pain, Biomarkers And Precision Medicine: Insurance Coverage Is One Ethical Challenge (Pink Sheet-$)
• US Biosimilar Market – Who's In It For The Long Haul? (Scrip-$)
• NABP Receives FDA Funding to Develop Data-Sharing System for Improved Oversight of Compounding Pharmacies (Press)
• Beyond DNA testing: Can analyzing RNA turn up more patients at risk of cancer? (STAT)
• ADC Therapeutics isn't going public in the US after all, while three other biotech IPOs bring in $319M (Endpoints)
• Label Restrictions After Accelerated Approval Impacts Use, Researchers Find (Focus)
• Nonclinical Studies for Enzyme Replacement Therapies: FDA Finalizes Guidance (Focus)
• ARC-T? Alternative CAR-T startup bags $85M for clinical quest to redirect 'blind hunter' T cells (Endpoints)
• The Real Impact Of Drug Price Legislation On Biopharmaceutical R & D (Fobres)
• How Recession Proof Is The Pharmaceutical Industry? (Forbes)
• GSK Chief Emma Walmsley voices support for equal pay campaign (Pharmafile)
• Neoantigen player PACT Pharma woos Tim Moore from Kite to run technical ops (Endpoints)
• Veeva acquires Crossix, pairing doctor, patient data and marketing services (Fierce)
• Viscient Bio Proposes Organovo Merger to Tackle NASH and Go Beyond (Xconomy)
• Most kidney transplants between people with HIV have long-term success (NIH)
• In women with HIV, TB preventive therapy poses greater risk in pregnancy than postpartum (NIH)
• NIH researchers create new viral vector for improved gene therapy in sickle cell disease (NIH)
• Zebrafish earn their drug discovery stripes (Nature)
• Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer (NIH)
• Prospective Grant of an Exclusive Patent License: Compositions, Devices and Processes for Production and Delivery of Cell Grafts of Manufactured Retinal Pigment Epithelium Cell(s) Alone, or in Combination With Photoreceptor Cells, and on a Biodegradable Support Scaffold Transplanted Subretinally for Intra-Ocular Ophthalmic Treatment of Conditions of Degeneration, Dysfunction or Terminal Injury of Retinal Pigment Epithelium and/or Photoreceptors in Humans (NIH)
• Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry; Availability (FDA)
• Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; Correction (FDA)

• Amicus rare disease data build hope for approval (BioPhamraDive)
• FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer (Press)
• FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections (Press)
• GSK Submits Filing to FDA for Trelegy Ellipta Use in Patients With Asthma (Press)
• Boehringer Ingelheim touts Spiolto Respimat inhaler data (MassDevice)
• Teva to Present New Data on AUSTEDO® (deutetrabenazine) Tablets at Psych Congress 2019 (Press)
• Moderna to Present Data From Two of Its Prophylactic mRNA Vaccines at IDWeek 2019 (Press)
• Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program (Press)
• Graybug Vision Initiates Phase 2b (ALTISSIMO) Clinical Trial of GB-102 in Patients with Wet Age-Related Macular Degeneration (Press)
• Shionogi presents positive Phase III data for unique antibiotic (PharmaLetter-$)

• RAPS retrospective: Navigating a challenging medical device regulatory environment (Emergo)
• FDA's New Medical Device Rules Speed Up Review Process (Law360-$)
• Siemens Healthineers absorbs healthcare consultancy ECG (MassDevice)
• Maquet recalls arterial filters (MassDevice)
• W.L. Gore’s Cardioform ASD Occluder Obtains CE Mark (MDDI)
• Cepheid Xpert BCR-ABL Ultra Leukemia Monitoring Test Gets FDA Clearance (GenomeWeb)
• FDA Clears the Smart-C Advanced X-ray Imaging System from Turner Imaging Systems (Press)
• Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance (Press)
  LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus (MassDevice)
• Outset Medical wins HHS contract for Tablo home dialysis device (MassDevice)

• Ex-Theranos CEO Says Feds' Discovery Delay Is 'Deja Vu' (Law360-$)
• J&J Settlement Leaves Teva As Sole Opioid Maker In Bellwether Trial (Pink Sheet-$)
• Sanders presidential campaign pivots health scare to Medicare for All message (Reuters)
• N.Y. Declares That the End of the AIDS Epidemic Is Near (NYTimes)
• Big Ruling in Philadelphia: The Controlled Substances Act does not forbid a safe drug consumption room (Harvard Bill of Health)
• Asahi Kasei files complaint against Endo over Xiaflex supplies (Pharmaletter-$) (Press)
• Iffy Propositions (Drug & Device Law)
• Distorted Drug Patents: Does the US Legal System Steer Researchers Away From Drugs that Take a Long Time to Develop? (FDA Law Blog)
• ND Illinois Knocks Out Helmet Concussion Class Actions (Drug & Device Law)
• Three Chinese Nationals Charged With Fentanyl Trafficking (WSJ)
• Virginia doctor sentenced to 40 years in opioid case (AP)
• VA Health Care: Additional Training Could Improve Organ Transplant Referral and Evaluation Processes (GAO)

• FDA Advisory Committee Calendar

• EMA Fee Revisions Expected To Resolve EC's Objections To ICH Q12 Guideline (Pink Sheet-$)

• First-line lung cancer approval for Keytruda in China (PharmaLetter-$)
• NMPA Approves IND Application for CT103A, a Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by IASO BIO and Innovent Biologics (Press)
• Agilent Receives Approval for First PD-L1 Companion Diagnostic in China (Press)

• Alembic Pharma to invest Rs. 700 crore for expansion of business (PharmaBiz)
• Lupin appoints Sreeji Gopinathan as its CIO (Economic Times)
• Indian pharma cannot ignore the emerging opportunities in Bangladesh: Experts (PharmaBiz)
• DCGI kickstarts online registration of ECs reviewing biomedical and health research for effective regulation (PharmaBiz)

• Biocon, Mylan launch insulin biosimilar in Australia (Economic Times)
• Update - contamination with N-nitrosodimethylamine (TGA)
• Not so much TMI as CMI: empowering consumers with clear, accessible information about their medicines (TGA)

• Countries agree plans to increase organ donation and transplant, promote health and improve health information systems: Day 3 of the 57th Directing Council (PAHO)
• A 15-year review of the PEPFAR support to Malawi: How Has it Succeeded? (Harvard Bill of Health)
• PEPFAR and Health Systems Transformation in Nigeria (Harvard Bill of Health)