Regulatory Focus™ > News Articles > 7 > Recon: Trump Shames Pharma Over Price Hikes, FTC Clears $62B Takeda-Shire Deal

Recon: Trump Shames Pharma Over Price Hikes, FTC Clears $62B Takeda-Shire Deal

Posted 10 July 2018 | By Ana Mulero 

Recon: Trump Shames Pharma Over Price Hikes, FTC Clears $62B Takeda-Shire Deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Trump says Pfizer, others 'should be ashamed' for raising drug prices (CNBC) (The Hill) (STAT)
  • Azar Calls for Changes in 340B Drug Pricing Program (MedPage Today) (STAT-$)
  • HHS secretary: Recent drug price increases 'creating a tipping point' (The Hill)
  • After rosiptor's phase 3 rout, Aquinox to cut staff by 53% (Fierce) (Endpoints)
  • A 7-year-old alliance between Celgene and Acceleron is paying off with more promising PhIII data for luspatercept (Endpoints) (Fierce) (The Pharma Letter-$)
  • Nanoparticles give immune cells a boost (MIT News) (Fierce)
  • Gene edited monkeys offer hope for heart disease patients (Science) (Endpoints)
  • Brett Kavanaugh, Trump’s pick for court, has left trail of opinions on health care and pharma issues (STAT) (Axios)
  • Widely-used blood pressure drug could help treat type 1 diabetes (Axios) (Medscape)
  • Pallone To Walden, Burgess: Hold A Hearing On REMS Abuse, CREATES Act (Inside Health Policy-$) (Bloomberg-$)
  • Takeda Clears FTC Hurdle for $62 Billion Shire Deal (Bloomberg) (Reuters) (Financial Times)
In Focus: International Pharmaceuticals & Biotechnology
  • Not All Drugs Are Created Equal - Purity And Potency Now Shaping The U.S. Drug Crisis (Forbes)
  • BIO Recommendations for Tax Reform 2.0 Package (BIO)
  • In subtle mixing of messages, the drug industry tries to press Congress to lift burden for more drug costs (STAT-$)
  • Gene-drive technology must be developed in a safe, ethical way (STAT)
  • Mylan decimates the list price of its Copaxone copy. But why? (Fierce)
  • Akorn Warned on Production Before Fresenius Deal, Executive Says (Bloomberg-$)
  • With Amazon in the wings, J&J retains dominant lead in pharma (The Pharma Letter-)
  • Summit Awarded up to $4.5 Million Grant from CARB-X for Development of New Mechanism Gonorrhoea Antibiotics (Press)
  • Allogene Therapeutics Announces Scientific Advisory Board (Press)
  • Symphogen A/S and Selexis Expand Relationship as Symphogen Advances its Monoclonal Antibody (mAb) Mixture Pipeline (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA Nixes United Therapeutics Petition on Tyvaso-Referencing Combination Products (FDA News)
  • Teva Announces Launch of a Generic Version of Uceris in the United States (Press)
  • MediciNova Announces Clinical Data from Subgroup Analyses of Completed Clinical Trial of MN-166 (ibudilast) in ALS (Press)
  • VIVUS Announces Positive Results from a Phase 1 Clinical Trial of VI-0106 (Press)
  • Anti-PD-L1 Immunotherapy Plus ABRAXANE Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study (Press)
  • Aravive Biologics Completes Phase 1 Trial of Novel GAS6-AXL Pathway Inhibitor, AVB-S6-500 (Press)
  • Tetra Discovery Partners Initiates Phase 2 Trial of BPN14770 in Fragile X Syndrome (Press)
  • Cancer Discovery Features H3 Biomedicine Paper Highlighting Effects of Selective Estrogen Receptor Covalent Antagonists (SERCAs) in ERα Wild-Type and Mutant Breast Cancer Models (Press)
Medical Devices
  • Mobile Health Apps Get An FDA Push (Fortune)
  • Balancing Aesthetics and Usability in Medical User Interface Design: 9 Key Trends (Emergo Group)
  • Zimmer Biomet Pushes Back on 'Misunderstandings' During Latest FDA Inspection (MD+DI)
  • Medtronic warns on connectivity issue with Guardian Connect app (DDBN)
  • Lifecare goes public to support implantable glucose meter (DDBN)
  • Sofinnova Partners Announces the Sale of ReCor Medical to Otsuka Holdings (Press)
  • RedDress Receives FDA 510(k) Clearance for RD1 System (Press)
  • Senseonics & Glooko Announce Partnership on Integrated Diabetes Management (Press)
  • First-Year Results from Medtronic and UnitedHealthcare Value-Based Relationship Demonstrate Cost-Savings and Reduced Hospital Admissions (Press)
  • Consumer Information on: enVista One Piece Hydrophobic Acrylic Toric Intraocular Lens - P910056/S027 (FDA)
  • Consumer Information on: iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) – P170043 (FDA)
US: Assorted & Government
  • Federal Circuit Decision in Medical Device Case Sheds Light on “Exceptionality” Analysis for Attorney Fees (Covington)
  • USPTO Issues Memorandum on Vanda Pharmaceuticals v. West-Ward Pharmaceuticals (Patent Law Blog)
  • Amid Executive Shuffle, Anthem Looks To Expand Health Services (Forbes)
  • Where the money stands in ACA risk adjustment (Axios)
  • CMS Administrator Seema Verma presses for remote monitoring of patients (MobiHealthNews)
  • Cerner sinks $266M into Lumeris as part of strategic partnership targeting Medicare Advantage plans (Fierce)
  • GAO Confirms It: 340B Hospitals and Contract Pharmacies Profit from Low-Income, Uninsured Patients (Drug Channels)
Upcoming Meetings & Events Europe Asia
  • 7 things you need to know now about raising biotech cash in China (Part 1) (Endpoints)
  • Israeli firm gets U.S. nod for advanced trials for non-opiate painkiller (Reuters)
  • Korea finished drug market growth driven by generics (Pharmabiz)
  • Shire launches new Hemophilia A treatment in Korea (Korea Biomedical Review)
  • Local drug makers strive to conquer neurological diseases (Korea Biomedical Review)
  • Transgene and Tasly Biopharmaceuticals Conclude Strategic Agreements for the Rights of Transgene’s Virus-Based Immunotherapies TG6002 and TG1050 in Greater China (Press)
  • Philips receives MFDS approval to market Philips IntelliSite Pathology Solution for primary diagnostic use in South Korea (Press)
  • Health ministry to amend D&C Rules to make marketing companies also accountable for quality of medicines (Pharmabiz)
  • Clinical trials not mandatory for licensing ASU drugs, says govt; researchers warn of fraud, textual data manipulation (Pharmabiz)
  • Misreading the pharma market (The Indian Express)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Mental Health of Children in Australian Detention Center Reaches ‘Crisis Point’ (NYT)
  • Australian experiment wipes out over 80% of disease-carrying mosquitoes (CNN)
  • Prototype uses Google's radar, AI tech to noninvasively measure glucose levels (MobiHealthNews)
  • Stillbirths: Australia's health policies 'failing these babies and their families' (The Guardian)
General Health & Other Interesting Articles
  • People are using Fitbits and Apple Watches to monitor their heart rate when binging on drugs — and doctors say it's a bad idea (CNBC)
  • Physicians’ beliefs may override cancer patients’ wishes for end-of-life care, study finds (STAT)
  • Fewer older black patients survive long-term after cardiac arrest in the hospital (Reuters)
  • How one startup is bringing blockchain to genomics and precision medicine (Healthcare IT News)
  • What if people were paid for their data? (The Economist)
  • Medical Clinics That Treat Refugees Help Determine The Case For Asylum (NPR)
  • Dying Organs Restored to Life in Novel Experiments (NYT)
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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