Recon: FDA Approves Sanofi’s Dengue Vaccine With Major Restrictions

• FDA approves the first vaccine for dengue fever, but with major restrictions (STAT) (Reuters) (Endpoints) (Press)
• Sales of Amarin’s heart drug are surging, but the stock not so much. Here’s why (STAT)
• Trump Administration Files Formal Request to Strike Down All of Obamacare (NYTimes) (Politico)
• Patients' drug costs surge for some neurologic conditions (Reuters) (STAT)
• Merck steps up US measles vaccine production with increased demand (Reuters)
• Going global, Takeda opens up 165,000-square-foot R&D facility in San Diego (Endpoints)
• Bluebird’s myeloma CAR-T safety ‘could support outpatient use’ (PMLive)
• FDA speeds Bayer's J&J-Pfizer showdown with darolutamide 'priority' (Fierce)
• Drugmaker Indivior promises ‘strong defences’ against US fraud charges (Financial Times)
• Express Scripts excludes Lilly's low cost insulin generic from preferred formulary (BioCentury)
• McKesson to pay $37 million to resolve West Virginia opioid lawsuit (Reuters)
• Trump’s claim of ‘amazing’ success in cutting opioid prescriptions (Washington Post)
• American Cancer Society says high health costs cause financial strain for more than 130 million US adults (CNBC)

• AstraZeneca ties up with France's Transgene to develop viral immunotherapies (Reuters) (Endpoints)
• Generic competition puts pressure on revenues at drugmaker Teva (Financial Times)
• Ebola outbreak in Congo hits record for confirmed cases in single day (CNN)
• Launching a new gene therapy will be the biggest test yet for Novartis CEO Narasimhan (STAT)
• Healthineers sees diagnostics drag on full-year profitability (Reuters)
• Why did GSK kill two vaccine R&D programs? CEO Emma Walmsley is glad you asked (Endpoints)
• UK Plan To Speed Access To ‘Cutting-Edge’ Products (Pink Sheet-$)
• US govt retains India in 'Priority Watch List' for alleged poor enforcement of IP regulations (Pharmabiz)
• Smith & Nephew optimistic on full-year sales after acquisition spree (Financial Times) (MassDevice)
• Cystic Fibrosis Triplet Could Unblock EU Reimbursement Impasse (SCRIP-$)
• Roche's Tecentriq-Avastin lung cancer combo gets a lift from England's cost watchdogs (Fierce)
• Medicine Price Transparency Under Scrutiny At Next World Health Assembly (Pink Sheet-$)
• WHO Prequalifies Abbott HIV Viral-Load POC Test (GenomeWeb)

• The start-up striving to accelerate drug discovery (Financial Times)
• Researchers Question Benefits of Pharma Protections in US Trade Deals (Focus)
• SMA Moment: Will Gene Therapy Shift Treatment, Costs of Muscle Disease? (Xconomy)
• The BCMA frenzy: Tracking the 37 drugs around the world racing to overtake bluebird bio and Celgene (Endpoints)
• How Drug Companies Helped Shape A Shifting, Biological View Of Mental Illness (NPR)
• Alternative medicine practitioners may market bogus celiac tests, treatments (Reuters)
• Cigna: Express Scripts Addition Already Brings Patients Quicker Treatment (Forbes)
• Anti-Infective Drugs Tied to Eating Disorders (NYTimes)
• Microbiome player uBiome puts founders on leave, interim CEO promises to assist in federal probe (Endpoints) (Forbes)
• Medication use drops when local drugstores close (Reuters)
• Substandard control arms question the utility of some new cancer drugs (STAT)
• Eli Lilly's erectile dysfunction drug Cialis shows signs of reversing heart failure in sheep (Fierce)
• Arcus hires ex-AbbVie, Genentech researcher as CMO (Fierce)
• Fixing a ‘market failure’: To develop new antibiotics, upend the incentive structure, experts urge (STAT)
• Bristol-Myers Squibb Company Announces Results of Early Participation in Exchange Offers and Consent Solicitations for Celgene Corporation Notes (Press)
• Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake (Pink Sheet-$)
• Weeks after a Pfizer/Merck KGaA breakdown, Clovis gambles on a $175M loan to finish a global PhIII PARP/PD-1 combo study (Endpoints)
• Terry Rosen is looking to leave the thundering herd and blaze a new trail in PD-1 R&D (Endpoints)
• Sage Therapeutics Announces First Quarter 2019 Financial Results and Highlights Pipeline and Business Progress (Press)
• NantHealth to Report 2019 First-Quarter Financial Results and Host Conference Call on Thursday, May 9 (Press)

• Biogen's antisense ALS drug shows promise in early clinical trial (Fierce)
• Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint (Press)
• Ligand Completes Enrollment of Phase 1 Clinical Trial of Captisol-enabled Iohexol (Press)
• Celgene Corporation and bluebird bio Announce Results from Ongoing Multicenter Phase 1 Study of bb2121 anti-BCMA CAR T Cell Therapy in Patients with Multiple Myeloma Published in New England Journal of Medicine (Press)
• Audentes Therapeutics Presents New Positive Data from ASPIRO, the Phase 1/2 Clinical Trial of AT132 for X-linked Myotubular Myopathy, at 22nd Annual Meeting of the American Society of Gene and Cell Therapy (Press)
• Dicerna™ Submits Updated IND Application for DCR-PHXC for Treatment of Primary Hyperoxaluria (PH) for the PHYOX™2 Pivotal Trial (Press)
• Exelixis Initiating Phase 3 Pivotal Trial (COSMIC-313) of Cabozantinib in Combination with Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma (Press)
• Context Therapeutics and World-Renowned Cancer Center Announce a Phase 2 Trial for Apristor® in Progesterone Receptor Positive Gynecological Cancers (Press)
• BioTime Presents Updated Data from OpRegen® Phase I/IIa Clinical Study at the Association for Research in Vision and Ophthalmology Annual Meeting (Press)
• Mallinckrodt to Present Open-Label Results from Phase 4 Acthar® Gel (Repository Corticotropin Injection) Clinical Trial in Patients with Rheumatoid Arthritis at Annual European Congress of Rheumatology (EULAR 2019) (Press)

• CDRH Launches ‘Super Office’ (Focus)
• 3M to Acquire Acelity for $6.7B (MDDI)
• 3D Printed Implantable Devices: Health Canada Offers Guidance (Focus)
• Abiomed wins FDA nod for STEMI Impella trial, sees shares drop on Q4 sales miss (MassDevice)
• Concept Medical Inc. Granted 'Breakthrough Device Designation' From FDA for Its MagicTouch Sirolimus Coated Balloon (Press)
• Medtronic wins FDA approval for CareLink SmartSync CRM device manager (MassDevice) (Press)
• LENSAR® Laser System Receives FDA Clearance to Perform Micro Radial Incisions to Optimize Outcomes of Refractive Cataract Procedures (Press)
• Teleflex shares rise on Street-beating Q1 (MassDevice)
• FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial (Press)
• Binx Health Gets CE Mark for Chlamydia, Gonorrhea Point-of-Care Test (GenomeWeb)

• Even many who support Trump’s drug rebate policy don’t support it in Medicaid (STAT)
• How Would a Single-Payer Health System Pay for Drugs? CBO Explains (Focus)
• Capping Off The Rebate Debate: Will 2019 Price Push End With Co-Pay Cap? (Pink Sheet-$)
• State attorneys general sharply criticize a government task force over opioid prescribing (STAT)
• Neptune Generics, LLC v. Eli Lilly & Co. (Fed. Cir. 2019) (Patent Docs)
• SEC Must Decide On Teva Whistleblower Award, DC Circ. Told (Law360-$)
• Florida Court Transfers Hip Implant Case to a New Jersey Court That May Also Lack Personal Jurisdiction (Drug & Device Law)

• FDA Advisory Committee Calendar
• Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients; Public Workshop – 8 August 2019

• “Prevention more important than cure”, say MPs on NHS (PharmaTimes)
• Industry Guide Could Ease EU Adoption Of Reverse Osmosis For Pharmaceutical Water (Pink Sheet-$)

• Substandard drugs are a bigger problem for India than fakes (Economic Times)

• Vitex agnus-castus (TGA)