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


Posted 15 April 2019 | By Michael Mezher 

Recon: Catalent to Buy Gene Therapy Manufacturer Paragon for $1.2B
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • 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)

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In Focus: International

  • 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)

Pharmaceuticals & Biotechnology

  • 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)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • 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)

Medical Devices

  • 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)

US: Assorted & Government

  • 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)

Upcoming Meetings & Events

Europe

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

General Health & Other Interesting Articles

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

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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A story’s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.




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