Recon: NY AG Sues Stem Cell Clinic Over Unproven Therapies

• The last day of Commissioner Gottlieb (Politico) (FDA)
• Powerful House committee to weigh legislation aimed at shedding more light on high drug prices (STAT)
• Oklahoma drops several claims in opioid case against J&J, Teva (Reuters)  (Law360-$)
• Drug company founder, execs exploited patients to sell opioid: US prosecutor (Reuters)
• Dems struggle to unite behind drug price plan (The Hill)
• NY Attorney General Sues Manhattan Stem Cell Clinic, Citing Rogue Therapies (NYTimes)
• A growing number of states are eyeing laws to prohibit a controversial cost-sharing tool (STAT)
• Guarding a $2 billion franchise operation, Gilead hustles up its sNDA for Descovy. But will it work? (Endpoints) (Press)
• The point of no return for Merrimack? Cancer drug developer axes yet another drug and more staff (Endpoints)
• To counter a lawsuit, Bristol-Myers outlines how the big Celgene buyout will shower $187M-plus on Morgan Stanley (Endpoints)
• Exemptions Surge As Parents And Doctors Do ‘Hail Mary’ Around Vaccine Laws (KHN)
• FDA Identifies ARBs Without Impurities (Focus) (Bloomberg)
• Fear, Loathing and Fentanyl Exposure (NYTimes)
• FDA and CBP bolster collaboration to protect public health and safety (FDA)

• The IVD industry is undergoing significant change. Join BSI experts at their In-Vitro Diagnostic Regulation Workshop to learn about the most significant changes to the European Regulatory and Compliance Expectations for CE marking. Topics such as an IVDR Overview including Classification and Grouping Devices, interacting with the Notified Body, Technical Documentation Requirements, New Requirements for Performance Evaluation and Using the Remaining Transition Period Effectively will be covered. Register here.

• Apollo, CVC Are Vying for Perrigo's Pharmaceuticals Unit (Bloomberg)
• Canadian Drugmaker Apotex Weighs Sale Amid Interest (Bloomberg)
• Invossa, first treatment to have used cancerous cell lines (Korea Biomedical Review)
• WHO: ‘Marked Increase’ In Ebola Cases in DR Congo (WHO)
• China May Save $30 Billion With Generic-Drug Plan, Novartis Says (Bloomberg)
• Pricing a hurdle for next-gen devices, but Canadian robotics company says change is coming (Fierce)
• EU approves new dosing schedule for MSD’s Keytruda (PharmaTimes)
• BMS Opdivo/Yervoy recommended for untreated kidney cancer via Cancer Drugs Fund (Pharmafile)
• US And EU Regulators Eye Co-operation In Expedited Pathways (Pink Sheet-$)
• New International Signal Detection Initiative To ‘Influence Industry Practice' (Pink Sheet-$)
• Canada and France Suspend Sales of Certain Breast Implants Linked to Cancer (Focus) (Reuters) (NBC)

• Cancer’s Trick for Dodging the Immune System (NYTimes)
• Antifungal agent fights cystic fibrosis (Nature)
• When a REMS is Necessary: FDA Finalizes Guidance (Focus)
• Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance (Focus)
• Blink Health Wanted to Change the Way Drugs Are Sold. Then Things Got Messy (Bloomberg)
• Pharma's mammoth immunology market? It's only getting bigger: analysts (Fierce)
• Pediatric Testosterone Therapy: Sponsors Wary Of Trials Despite PREA (Pink Sheet-$)
• The case of the missing PD-L1: UCSF sleuths devise a new ‘tumor cell vaccine’ and a checkpoint strategy that could surprise you (Endpoints)
• Peer Review: Plotting US moves, Zealand Pharma poaches Alnylam’s Emmanuel Dulac as new CEO (Endpoints)

• Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA (Press)
• UroGen Pharma Announces Presentation of Analysis from Phase 3 OLYMPUS Trial of UGN-101 for Patients with Low-Grade Upper Tract Urothelial Cancer (Press)
• Trovagene Announces Update to Phase 1b/2 AML Trial Data Presented at AACR - Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib (Press)

• FDA’s De Novo Program Gains Momentum (Focus)
• Top 5 issues for medical device risk management and design controls (Emergo)
• Presbia delays Flexivue Microlens FDA PMA approval timeline again (MassDevice)
• Medtronic touts stroke data for HeartWare LVAD (MassDevice)
• Medtronic HeartWare(TM) HVAD(TM) System Demonstrates Reduction in Total Strokes, Disabling Strokes and Stroke-Related Mortality with Blood Pressure Management (Press)
• Class 1 Device Recall: e500, e600 and e700 Automatic Transport Ventilator (FDA 1, 2, 3)
• Catapult, Smithwise slated to merge (MassDevice)
• Orthofix Medical touts data from artificial disc study (MassDevice)

• Trump Is Being Vague About What He Wants to Replace Obamacare. But There Are Clues. (NYTimes)
• Can Technology Stop the Duane Reade-ization of New York? (NYTimes)
• Memorial Sloan Kettering Leaders Violated Conflict-of-Interest Rules, Report Finds (NYTimes) (Endpoints)
• US regulators forcing PatientsLikeMe’s Chinese majority owner to sell its stake (MedCityNews)
• Medicaid “Right Rebate” Provisions Clear Congress (FDA Law Blog)
• Frivolous Friday − Name Dropping (Drug & Device Law)

• FDA Advisory Committee Calendar
• Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting – 7 May 2019
• Oncologic Drugs Advisory Committee; Notice of Meeting – 14 May 2019

• Edwards Lifesciences doubles down on Irish plant (MassDevice)
• EuroBiotech Report—U.K. startups boost, AgomAb funding, Novartis' IFM deal and Galapagos' success (Endpoints)
• Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)
• Good clinical practice for clinical trials (MHRA)

• Regulators seek protection for regulatory officers in the wake of Neha Shoree’s murder (PharmaBiz)
• Gujarat FDCA approves layout designs of 225 pharma companies post GST (PharmaBiz)

• Submissions received: Proposed therapeutic goods advertising code guidance (TGA)

• No U.S. labs follow all guidelines for 'cell-free' prenatal testing (Reuters)