Recon: Catalent to Buy Gene Therapy Manufacturer Paragon for $1.2B

• US Supreme Court rejects Allergan bid to use tribe to shield drug patents (Reuters) (STAT)
• Contract Drug Manufacturer Catalent to Buy Paragon Bioservices in $1.2 Billion Deal (WSJ) (Reuters) (Endpoints)
• Johnson & Johnson wins US FDA approval for bladder cancer drug (Reuters) (FDA) (Press)
• Democrats feud over drug pricing policy, as progressives push pragmatists to be bolder (STAT)
• OMB’s New Reviews of FDA Guidance May Be a Boon for Biopharma Industry (Focus)
• Clovis Oncology halts mid-stage bladder cancer trial, shares drop (Reuters)
• J&J, Merck and Pfizer spent tax savings on investor payouts, not R&D: Oxfam (Fierce)
• US sees surge in confirmed cases of measles, CDC reports (NBC)
• Biopharma CEOs Explain Problems With Biosimilars to Congress (Focus)
• How Can We Be Sure Artificial Intelligence Is Safe For Medical Use? (NPR)
• Peter Bach’s latest crazy idea: Give up on biosimilars. Regulate drug prices instead (STAT) (Health Affairs 1, 2)
• Latest Alnylam data underscores positive results for new RNAi drug candidate, at least for some patients (STAT) (Xconomy) (Press)
• Medicare Aims to Expand Coverage of Cancer Care. But Is It Enough? (NYTimes)
• Republican Sen. Chuck Grassley doubts Obamacare will be ruled unconstitutional (CNBC)
• Health-care stocks plunge as uncertainty rises on Obamacare, Congress threatens action on drug prices (CNBC)

• As Ebola Cases Rise in Congo, the WHO Declines to Issue Emergency Declaration (NYTimes) (Reuters)
• The data are clear: Ebola vaccine shows ‘very impressive’ performance in outbreak (STAT)
• At WHO Forum on Medicines, countries and civil society push for greater transparency and fairer prices (WHO)
• Measles cases rose nearly four-fold in first quarter 2019: WHO (Reuters)
• Chi-Med Planning Hong Kong Listing (BioCentury)
• Gene-Edited Babies: What a Chinese Scientist Told an American Mentor (NYTimes)
• He Jiankui, embryo editing, CCR5, the London patient, and jumping to conclusions (STAT)
• Dr Reddy's acquires a portfolio of 42 ANDAs in US (Economic Times) (Press)
• Diverging from US, Canada Approves Biosimilar Rituximab in Both Oncology and Rheumatology Indications (Center for Biosimilars)

• FDA Softens Stance on Drinking Alcohol With Female Libido Drug (Focus)
• Top cancer hospitals' outcomes may be better than affiliates' (Reuters)
• Insys CEO Resigns Amid Uncertain Future (Law360-$)
• Why Astronomical Drug Prices Are Bad For Health — And Profits (NPR)
• Allergan wins support against dissident shareholders (PMLive)
• The HPV vaccine is important for preteens and teenagers. What about older women? (Washington Post)
• New cancer therapies offer great hope, but there can be suprising complications (Washington Post)
• Influential proxy firms kick back at activists’ demands for Brent Saunders to give up his chairman’s title at Allergan (Endpoints)
• Pfizer, AstraZeneca and J&J Take Issue With FDA’s List of Companies Withholding Drug Samples (Focus)
• Four biotech Nasdaq wannabes outline IPO plans — and don’t miss Chi-Med’s HKEX pitch (Endpoints)
• Road warrior: Hal Barron’s global R&D crusade at GSK comes with a hefty $800,000-plus travel budget (Endpoints)
• Fibrocell Science sees light at the end of the tunnel with Castle Creek deal to develop ‘butterfly’ disease gene therapy (Endpoints)
• This venture player is plotting $200M in new biotech investing — and they’re doubling down on a startup-rich strategy (Endpoints)
• EIP bags cash to trial ex-Vertex drug in dementia, Huntington's (Fierce)
• Determination of Regulatory Review Period for Purposes of Patent Extension; SYMPROIC (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring (FDA)
• Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals (FDA)

• Outracing 2 giant rivals, J&J touts promising PhIII Invokana data as a game-changer for kidney disease risks (Endpoints)
• Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older (Press)
• Alnylam Initiates ILLUMINATE-B Phase 3 Pediatric Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 and Presents New Positive Results from Phase 2 Open-Label Extension Study (Press)
• Hansa Biopharma Receives Ethics and Regulatory Clearance to Start Phase 2 Study of Imlifidase in Guillain Barré Syndrome (Press)
• Results of Phase 3 Trial Evaluating Merck’s ZERBAXA® (ceftolozane and tazobactam) versus Meropenem for Treatment of Adult Patients with Ventilated Nosocomial Pneumonia (VNP) to be Presented at ECCMID 2019 (Press)
• Promethera Biosciences Presents Updated Phase 2a Results for World’s First Stem Cell Clinical Trial in ACLF at The International Liver Congress™/ EASL 2019 (Press)
• Arrowhead Presents Clinical Data on JNJ-3989 (ARO-HBV) at The International Liver Congress™ (Press)
• Arrowhead Pharmaceuticals Receives FDA Clearance to Begin Phase 2/3 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
• Zymeworks Opens Phase 2 Clinical Trial for ZW25 in First-Line HER2-Expressing Metastatic Gastroesophageal Cancers (Press)
• CStone received IND approval in China for avapritinib Phase I/II bridging registrational study in patients with advanced gastrointestinal stromal tumors (Press)

• Doctors Use Electrical Implant to Aid Brain-Damaged Woman (NYTimes)
• Philips to private-label Demant hearing aids (MassDevice)
• Stryker wins FDA PMA, launches Lifepak CR2 AED (MassDevice)
• FDA approves Intact Vascular’s Tack dissection repair device (MassDevice)
• FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix (MassDevice)
• Gelesis Granted FDA Clearance to Market PLENITY™ — a New Prescription Aid in Weight Management (Press)
• FDA Approves Qiagen Companion Dx for Bladder Cancer Drug Balversa (GenomeWeb) (Press)
• GenMark Diagnostics Obtains FDA Clearance for Gram-Negative Sepsis Panel (GenomeWeb)
• Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph (FDA)
• Intact Vascular’s Tack Endovascular System® Receives FDA Approval (Press)

• FY 20: The “Ask”; the Possible; and the Realities (Alliance for a Stronger FDA)
• No Shortage Of Opinions On New USPTO Eligibility Guidance (Law360-$)
• Judge Won't Certify Perrigo's Appeal In Drug Price-Fixing MDL (Law360-$)
• FDA pulls up Walmart, Kroger, others for selling tobacco to minors (Reuters)
• A critical deadline on Montana's Medicaid expansion (Politico)
• The Need for Real MDL Rules Will Only Grow More Acute (Drug & Device Law)
• DOJ Should Listen to Its Own Arguments (FDA Law Blog)

• FDA Advisory Committee Calendar

• The European Medicines Agency’s goals for regulatory science to 2025 (Nature)
• Field Safety Notice: 08-12 April 2019 (MHRA)

• John Oliver Goes After the Sackler Family With Help From a Famous TV Drug Dealer (Slate)