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

• 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)

• Wellcome launches £250m Leap Fund to back risky research (Financial Times) (STAT) (Fierce)
• Matt Hancock appointed health secretary in Brexit reshuffle (pharmaphorum)  (PharmaTimes)
• Dragon smiles on Indian pharma industry: Will China’s latest move help India bridge wide trade deficit (Financial Express) (Press Trust of India)
• Health Canada recalls heart drug due to contamination with possible carcinogen (The Globe and Mail) (Montreal Gazette)
• BioNTech, Genevant form mRNA pacts in rare diseases, oncology (Fierce)
• What India can teach the U.S. about driving down the cost of health care (STAT)
• Shanghai United Imaging Is Said to Weigh Bid for Supersonic (Bloomberg-$)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• Biocon Biosimilars Facility Receives EU GMP Certification (Big Molecule Watch)
• Three cancer treatments approved for use on NHS Scotland (PharmaTimes)
• Improving diagnosis and treatment of disease: new innovation fund (Innovate UK)
• Outbreaks of Koi herpesvirus (KHV) disease in 2018 (UK Centre for Environment, Fisheries and Aquaculture Science)
• Kamada Receives Positive Scientific Advice from European Medicines Agency on a New Phase 3 Study Design for Inhaled AAT (Press)

• 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)

• 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)