Recon: Takeda Completes $62B Shire Acquisition

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)