Recon: FDA Warns of Severe Worsening of MS After Stopping Gilenya; EC Signs Off on Takeda Acquisition of Shire

• Step off our 'donut hole' deal: AARP ads take on Big Pharma lobbying (Fierce)
• US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein (Pink Sheet-$)
• FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (FDA)
• Apple in Talks to Give Veterans Access to Electronic Medical Records (WSJ-$)
• Walgreens, Humana Are in Preliminary Talks to Take Stakes in Each Other (WSJ-$)
• FDA Chief Says Higher Prices Could Cure Drug Shortages (Bloomberg)
• The Bernie Sanders-Trump mind meld on drug costs (Politico)
• Drug companies snub Trump by hiking prices (Fox Business)
• Pfizer wants to reel back contributions to Hyde-Smith (Endpoints) (Washington Examiner)

• EU regulators approve Takeda’s acquisition of Shire after divestment (European Commission) (In-PharmaTechnologist) (Law360-$)
• Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications (EMA)
• BASF unveils major restructuring (C&EN)
• GSK retains leading position on access to medicines list (PharmaTimes)
• UK Providers Seek More Real-World Evidence, Financial Incentives for Biosimilar Use (Center for Biosimilars)
• Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration (TGA)
• Further guidance on producing and distributing effective field safety notices from medical devices (MHRA)

• Pharma companies put faith in AI for breakthroughs (Financial Times-$)
• Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about Others (FDA Law Blog)
• Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets (FDA)
• Dr. Reddy’s, Mylan Win Challenge To Arthritis Drug Patents (Law360-$)
• Fed. Circ. Lifts Block On Dr. Reddy's Suboxone Generic (Law360-$)
• Former Teva Exec Nabs $6.2M Bias Verdict After Firing (Law360-$)
• Court Denies Judgment on the Pleadings in Amgen v. Mylan (Big Molecule Watch Blog)
• Idorsia sheds surplus DMD therapy to Santhera (Fierce)
• Biogen tasks HitGen with discovering neurological leads (Fierce)
• Rentschler opens GMP fill/finish facility in Austria (BioPharma-Reporter)
• Jury finds former Aveo CFO David Johnston guilty of scheme to mislead investors (Endpoints)
• Who are the best — and worst — among the major pharmas at developing drugs for the poor? (Endpoints)
• Roche ties up again with Ascletis — this time on a commercial partnership for hep B drug (Endpoints)
• Clozel hands over a rival to PTC’s controversial steroid deflazacort (Endpoints)
• Astellas launches Global Health Foundation (PharmaLetter-$)
• LEO Pharma and PellePharm Announce $760 Million Collaboration to Advance Innovative Therapies for Rare Skin Diseases (Press)
• Ligand Announces OmniAb Partnership with iMetabolic Biopharma Corporation (Press)

• Protecting the Value of Medical Science in the Age of Social Media and “Fake News” (JAMA)
• Expanded Access Data Can Support Approval Decisions, US FDA Says (Pink Sheet-$)
• Estimation of global insulin use for type 2 diabetes, 2018–30: a microsimulation analysis (Lancet)
• Study: Biosimilar Filgrastim Use Is Concordant With EORTC Guidelines (Center for Biosimilars)
• Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ (Press)
• Stemline Therapeutics Announces that European Medicines Agency (EMA) Grants Accelerated Assessment for planned ELZONRIS Marketing Authorization Application (Press)

• FDA plans to convene an advisory committee meeting to share the available evidence and seek expert opinion about the safety and effectiveness of surgical mesh (FDA)
• Recall: Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results (FDA)
• Insulet’s Omnipod Dash system lands ISO cert for data security (DrugDelivery)
• Guidance on the regulation of menstrual cups in Australia (TGA)

• FDA's Woodcock: 'The clinical trial system is broken' (BiopharmaDive)
• Lawyer: Key Questions Linger With FDA’s New Drug Software Framework (InsideHealthPolicy-$)
• CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests (FDA)
• Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second Quarter of 2018 (HHS OIG)
• Trump admin reapproves Kentucky's Medicaid work requirement waivers (Politico)
• Acthar Proposed Giveaway Program Raises Kickback Concerns, OIG Says (Pink Sheet-$)
• Antitrust in the Pharmaceutical Sector: An Overview of U.S. Case Law (SSRN)
• FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder (FDA)

• FDA Advisory Committee Calendar

• Romaine lettuce is not safe to eat, CDC warns U.S. consumers (Washington Post)
• Why Don’t We Have Vaccines Against Everything? (NY Times-$)
• Scientists are trying to create a contraceptive that stops sperm in its tracks (Stat)
• Google Taking Over Health Records Raises Patient Privacy Fears (Bloomberg)
• BioMarin Sponsors Off-Broadway Show About Hemophilia (Reuters) (BioSpace)