Recon: FDA Places Hold on Abeona Cell Therapy Study; Novartis Expands Zantac Recall to US

• The Democrats shepherding Pelosi’s drug pricing bill have taken plenty of campaign cash from pharma (STAT)
• Drugmakers, Worried About Losing Pricing Power, Are Lobbying Hard (WSJ)
• Novartis expands recall of heartburn meds to U.S. after finding carcinogen (STAT)
• Abeona Therapeutics’ rare disease phase 3 trial halted due to FDA concerns (PMLive) (Endpoints)
• US recorded two new cases in measles outbreak last week (Reuters)
• How Anti-Vaccine Sentiment Took Hold in the United States (NYTimes)
• A Big Biotech Bet Hiding in Plain Sight (WSJ)
• FDA expands blood pressure drug recall, again (NBC)
• As Off-Label Use Spreads, Supplies Of Niche Drugs And Patients’ Patience Grow Short (KHN)
• A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices (House Ways & Means)

• Vaccination strategy in long-running Ebola outbreak comes under fire (STAT)
• Health Experts Fight Ebola in Congo, and Each Other (NYTimes)
• Tanzania summons World Health Organization rep over Ebola complaint (Reuters)
• 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR (Focus)
• Big Pharma's Catch 22 as China's Bulk Buy Plan Goes National (Bloomberg)
• Before heritable genome editing, we need slow science & global dialogue (STAT)
• Medicinal cannabis product Epidyolex approved in EU for childhood epilepsy (Pharmafile) (The Guardian)
• Once touted as Lyrica rival for diabetic nerve pain, Korean biotech's plasmid product implodes in PhIII (Endpoints)
• Evotec and Takeda enter into multi therapeutic area collaboration (Pharmafile)
• A Simple Regimen Can Prevent TB. Why Aren’t More People on It? (NYTimes)
• Indian Government to come up with list of over-the-counter drugs soon (Economic Times)

• In hunt for new drugs, Amazon and other tech giants are using AI to find protein structures (STAT)
• Catalyst stock dives, although the fledgling drug maker has no idea why (STAT)
• FDA Finalizes ALS Drug Development Guidance (Focus)
• Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight (JAMA)
• Is Regeneron losing its R&D mystique? Analyst discounts big biotech’s runner-up development strategy in an increasingly commoditized world (Endpoints)
• Startup EPM launches, high off acid-based cannabinoid innovation (Endpoints)
• Lundbeck’s Deborah Dunsire didn’t just want an ex-US deal for Alder’s migraine drug. She wanted the whole world (Focus)
• Ex-Retrophin BD chief flips his rare disease startup onto Nasdaq via reverse merger with Proteon (Focus)
• As Made-To-Order DNA Gets Cheaper, Keeping It Out Of The Wrong Hands Gets Harder (NPR)
• Akcea Shakes Up Management and Shows Three Executives the Door (Xconomy)
• Allergists Debate Anticipated FDA Approval Of A Peanut Allergy Drug (NPR)
• Sethi to leave AstraZeneca to take up Oncimmune post (Fierce)
• PPD boosts U.S. bioanalytical lab with hundreds of new staffers, expanded facilities (Fierce)
• Does disclosure of pharma payments harm patient trust in doctors? (BioPharmaDive)
• In Tiny Doses, An Addiction Medication Moonlights As A Treatment For Chronic Pain (NPR)
• 4 Biotech Firms Freshen Pipeline With IPOs Totaling $526M (Law360-$)
• States pull back curtain on drug prices, to uncertain effect (BioPharmaDive)
• UK Names Ferry Firms To Carry No-Deal Brexit Medicine Supplies (Pink Sheet-$)

• Ipsen announces positive phase 3 results in limb spastic hemiparesis (Pharmafile)
• New England Journal of Medicine Publishes Results of a Phase 2 Trial Evaluating Takeda’s TAK-620 (Maribavir) as a Potential Treatment of Cytomegalovirus (CMV) Infection (Press)
• Mitsubishi Tanabe Pharma Corporation Group Announces Presentation of Patient-Reported Results from Phase 2 ND0612 Study at International Congress of Parkinson's Disease and Movement Disorders (Press)
• Pfizer Presents New Evidence of IBRANCE® (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO Congress 2019 (Press)
• Bicycle Therapeutics to Present Updated Data from Phase I/IIa Trial Evaluating Lead Asset BT1718 in Patients with Advanced Solid Tumors at ESMO 2019 Annual Congress (Press)
• MC2 Therapeutics Announces Submission of New Drug Application to US FDA for Wynzora™ Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis (Press)
• Annexon Biosciences Announces FDA Fast Track Designation for Novel C1q Inhibitor ANX005 for the Treatment of Guillain-Barré Syndrome (Press)
• Arcus Biosciences to Present Updated Data from the Phase 1 Safety Dose-Escalation Portion of the AB928 Combination Trials at the European Society for Medical Oncology (ESMO) Meeting (Press)
• Aldeyra Therapeutics Receives Fast Track Designation for ADX-2191 for the Prevention of Proliferative Vitreoretinopathy (Press)
• Theraly Fibrosis Granted US Orphan Drug Designation for TLY012 for Chronic Pancreatitis (Press)
• Ocular Therapeutix™ Announces First Patient Dosed in Phase 3 Clinical Trial of DEXTENZA® for the Treatment of Allergic Conjunctivitis (Press)
• Neuralstem Announces Last Subject Enrolled in Phase 2 Clinical Trial Evaluating Human Neural Stem Cells in Chronic Stroke Patients (Press)
• Kadimastem Announces Promising Interim Results of Cohort A of Its Phase 1/2a Clinical Trial in ALS (Press)
• Protalix BioTherapeutics and Chiesi Group Complete Enrollment in the Third Phase III Clinical Trial of pegunigalsidase alfa (PRX‑102) for the Treatment of Fabry Disease (Press)

• Patient Engagement in Device Trials: FDA Drafts Guidance (Focus)
• FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance (Focus)
• Once Again, Medical Technology Industry Pushes To Derail The Device Tax (Forbes)
• Despite Exemptions, Medical Device Makers Wary Of Trump’s Trade War (Forbes)
• Diversity in medtech: Just 18% of executive roles held by women (MassDevice)
• Varian wins tariff exclusion for radiotherapy components (MassDevice)
• Class 1 Device Recall Infusomat Space Volumetric Infusion Pump Administration Set (FDA)
• Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip (Press)

• National Advertising Not Enough for General Jurisdiction (Drug & Device Law)
• Florida Proposes Plan to Import Drugs from Canada (FDA Law Blog)
• United States Gathers 350 Commitments to Combat Antibiotic Resistance, Action Must Continue (CDC)
• CDC Receives Designation as PAHO/WHO Collaborating Centre for Biosafety and Biosecurity (CDC)
• Abiomed claims win over Abbott’s Thoratec in German patent case (MassDevice)
• PTAB Should've Axed Cancer Detection Patent, Fed. Circ. Told (Law360-$)
• HHS Can Force Drug Prices In TV Ads, DC Circ. Hears (Law360-$)

• FDA Advisory Committee Calendar

• NICE calls for further research on tinnitus management (PharmaTimes)
• Welcome interim Chief Executive Dr June Raine (GOV.UK)
• French researchers build massive new scanner to tackle brain disease (Reuters)
• Class 2 Medicines Recall: Bisacodyl 10mg Suppositories EL (19)A/22 (MHRA)
• Exporting active substance manufactured in the UK in a no-deal Brexit (MHRA)
• Two benzoyl peroxide products to treat mild acne affecting the face to go on general sale (MHRA)

• Mitsubishi Tanabe files for Tenelia approval in China (PharmaLetter-$)
• China may roll out e-cigarette rules amid global vaping backlash: state media (Reuters)

• Chinese delegation to visit Tamil Nadu from October 5-15 to invite Indian pharma cos to invest in China (PharmaBiz)
• NGOs ask Indian govt to desist from Indo-US mini trade deal to dilute price cap on medical devices (PharmaBiz)
• Glenmark Pharma eyes 10-15% revenue growth for FY19-20 (PharmaBiz)
• International regulators’ meet helps exporters to understand changing regulatory landscape across the globe (PharmaBiz)

• 'Silent' celiac disease common in patients' close relatives (Reuters)