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Recon: Takeda Completes $62B Shire Acquisition

Posted 08 January 2019 | By Michael Mezher 

Recon: Takeda Completes $62B Shire Acquisition

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biotech Proposes Paying for Pricey Drugs by Installment (WSJ)
  • California to Flex Drug Purchasing Power (WSJ) (Reuters)
  • Price hikes on existing medicines account for the lion’s share of higher drug costs (STAT) (NPR) (Health Affairs)
  • All seven of the FDA’s recent commissioners agree it should be independent — but not on how to accomplish it (STAT) (Health Affairs) (Aspen Institute)
  • Gilead, Pfizer Execs Suggest Even More Pharma M&A Is on Way (Bloomberg)
  • Big Pharma Isn't Boring Any More as Cancer Deals Herald More M&A (Bloomberg)
  • Supreme Court seems unlikely to overhaul popular drug industry legal strategy (STAT)
  • US Supreme Court could side with Merck over Fosamax lawsuits (Reuters)
  • Court Rejects Trump’s Cuts in Payments for Prescription Drugs (NYTimes)
  • Democratic governors push coverage reforms (Politico)
  • Will prescription drugs get cheaper this year? An expert rates the odds. (USA Today)
In Focus: International
  • How Takeda's $62 Billion Shire Deal Reshapes Pharma World (Bloomberg) (Endpoints) (Financial Times)
  • GlaxoSmithKline CEO Emma Walmsley gets 'radical' about reshaping portfolio (CNBC)
  • Takeda to keep consumer business, looks outside Japan for selloffs instead: CEO (Fierce)
  • Novartis building out cell and gene therapy platform that'll lead the pack, CEO promises (Fierce)
  • Government unveils £20bn plan to revitalise NHS in England (Pharmafile)
  • Teva's escaped the generics 'death spiral,' but it can't take all the credit: CEO (Fierce)
  • Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa (Press)
  • PIC/S Guideline Sets Harmonized Approach For Classifying GMP Deficiencies Worldwide (Pink Sheet-$)
  • A Virus Even More Dangerous Than Zika to Pregnant Woman (NYTimes)
  • Regulatory Reforms in China Spark Samsung Bioepis Deal With 3SBio (BioCentury)
Pharmaceuticals & Biotechnology                                              
  • Opinion: The Drug Price-Control Threat (WSJ)
  • It’s day one at JPM19. Here’s what we heard and learned (STAT)
  • It’s Still The Prices, Stupid: Why The US Spends So Much On Health Care, And A Tribute To Uwe Reinhardt (Health Affairs)
  • Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating (Pink Sheet-$)
  • Medical Marketing in the United States, 1997-2016 (JAMA)
  • Billionaire Doctor Patrick Soon-Shiong Shares New Details On His Latest Cancer-Fighting Company—And How It’s Tied To His Other Firms (Forbes)
  • Retiring FDA Office of Generic Drugs Director Uhl Cautions Industry That Haste Makes Waste in Application Approval Timelines (IPQ)
  • Are drug targets with genetic support twice as likely to be approved? Revised estimates of the impact of genetic support for drug mechanisms on the probability of drug approval. (BioRxiv)
  • FDA’s New ‘Site Engagement’ Program Aims To Avert Quality-Related Drug Shortages (Pink Sheet-$)
  • In Puerto Rico, growing opioid crisis adds to island's post-hurricane issues (NBC)
  • JP Morgan Notebook Day 1: Pfizer, Gilead, Alnylam, Novartis, Sarepta, Deal Trends And Cell Therapy Challenges (Pink Sheet-$)
  • Championed by AbbVie, immuno-neurology player Alector maps $150M IPO (Endpoints)
  • Roche executive jumps ship to Ramaswamy’s Genevant, joining fellow former Big Pharma veteran (Fierce)
  • Prepping a cross-Pacific move, OrbiMed-backed Apollomics bags $100M Series B for I/O combos (Endpoints)
  • AstraZeneca rejigs commercial ranks around cancer, biopharma in wake of Mallon's departure (Fierce)
  • BI broadens research pact with Vanderbilt University to develop GPCR drugs for brain disorders (Fierce)
  • IPO bonanza as biotechs get in while the iron’s hot (or before it cools) (Fierce)
  • Parexel launches dedicated biotech division (Outsourcing Pharma)
  • Liz Barrett’s bet on UroGen proves timely, as biotech’s lead drug scores in key study (Endpoints)
  • Everyone Wants to Be a Biotech Banker Now (Bloomberg)
  • U.S. cancer death rate hits milestone: 25 years of decline (STAT)
  • ‘Left behind’: Drug companies and researchers have overlooked patients who don’t respond to HIV meds (STAT)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Billed as potential blockbuster, Novartis’ sickle cell drug scores FDA’s breakthrough therapy status (Endpoints) (Press)
  • PrimeVax Immuno-Oncology Receives IND Permission From FDA (Press)
  • Nobilis files IND for trial to study drug-device PTSD therapy (Drug Delivery)
  • UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) (Press)
  • Forbius Announces the First Patient Dosed in a Phase 1 Oncology Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor (Press)
  • Advicenne’s Flagship ADV7103 Receives Authorization for Pivotal Phase II/III Cystinuria Study in Belgium (Press)
  • Novus Therapeutics Doses First Patient with Acute Otitis Media in Phase 1 Study of OP0201 (Press)
  • NeuroBo Pharmaceuticals to Initiate Phase III Clinical Trial of NB-01 in Adult Patients with Diabetic Neuropathic Pain (Press)
Medical Devices
  • Does the 510(k) Program Need Predicate Modernization? (FDA Law Blog)
  •  2018 Year End Funding Report: Is digital health in a bubble? (Rock Health)
  • Curbing Unnecessary and Wasted Diagnostic Imaging (JAMA)
  • The Apple Watch 4 is an iffy atrial fibrillation detector in those under age 55 (STAT)
  • J&J Innovation gets in on NXT Biomedical incubator (MassDevice)
  • Terumo’s MicroVention wins FDA approval for Web brain aneurysm device (MassDevice)
  • ArcherDX's Companion Diagnostic Assay for both Liquid Biopsy and Tissue Specimens Granted Breakthrough Device Designation by U.S. Food and Drug Administration (Press)
  • Bruin Biometrics’ bedsore scanner wins de novo FDA approval (Medical Design & Outsourcing)
US: Assorted & Government
  • Argument analysis: Gleaning the FDA’s meaning for impossibility pre-emption (SCOTUS Blog)
  • PBMs To FDA: Prohibit Brand Drug Makers From Filing Citizen Petitions (IHP-$)
  • High Court Denies Gilead FCA Case After DOJ Thumbs-Down (Law360-$)
  • Preemption In Pharmaceutical Cases: 2018 In Review (Law360-$)
  • Tesaro Hit With Investor Suit Over $5B Merger Deal With GSK (Law360-$)
  • USPTO Issues Updated Subject Matter Eligibility Guidance (Patent Docs)
  • New Jersey Finds Preemption in Breast Implant Litigation (Drug & Device Law)
Upcoming Meetings & Events Europe
  • West London crooks convicted of conspiracy to supply illicit meds (MHRA)
  • Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation (Emergo)
  • 'Superbug' Molecular Test From Mobidiag Gets CE Mark (GenomeWeb)
  • Indian pharma companies grab 290 final ANDA approvals from US FDA in 2018 (PharmaBiz)
  • Zydus Cadila gets USFDA nod for antipsychotic drug (Economic Times)
  • Lupin gets European Commission nod for myotonia treatment drug (Economic Times)
General Health & Other Interesting Articles
  • Alzheimer's Disease May Develop Differently In African-Americans, Study Suggests (NPR)
  • Could Immunotherapy Offer a Cure for Cancer? (NYTimes)
  • Electric nanoparticles can target and kill cancer cells by zapping them (MIT Technology Review)
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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