Recon: Pfizer Agrees to Postpone Drug Price Hikes, Plans Split Into 3 Units

• Pfizer Agrees To Postpone Drug Price Hikes After Trump Tweet (NPR) (Bloomberg) (NYT) (Forbes)
• Pfizer to split into three units, separates consumer healthcare (Reuters) (WSJ) (Endpoints) (CNBC)
• Drugmakers Cancel Price Hikes After California Law Takes Effect (Bloomberg)
• BioCryst stockholders call off merger with Idera Pharmaceuticals (Fierce) (Endpoints)
• AZ makes gene therapy move with 4DMT alliance (PMLiVE) (Fierce)
• Ex-Akebia, Merrimack Analysts Found Guilty Of Insider Trades (Law360-$) (Reuters) (BioSpace)
• Testosterone Prescriptions Plunge After CVD Signals, FDA Alert (Medscape) (MedPage Today)
• Could FDA use off-label data for drug approvals? It’s possible, agency official says (STAT-$)
• FDA: New Warnings for Fluoroquinolones (MedPage Today) (Medscape)

• France launches 100 million euros biotech fund (Reuters) (Fierce) (Endpoints) (BioPharma Dive)
• Otsuka to acquire antibody developer Visterra in $430M deal (Fierce) (GEN) (Endpoints)
• Novartis punts a late-stage PI3K drug with a worrying safety profile to one of China’s upstart biotechs (Endpoints) (Fierce)
• VC raises new €270m fund for European biotechs (PMLiVE) (Scrip-$) (Endpoints)
• Tasly Gains Products As Transgene Sells Up China JV Stake (Scrip-$) (Endpoints)
• EMA agrees to Pharnext’s PIP for PXT3003 (The Pharma Letter) (Pharmabiz)
• Janssen launches PhII/III programme testing Tremfya in Crohn’s (PharmaTimes) (Fierce)
• Medical Device Industry Braces for Tariffs on Chinese Goods (AAMI)
• Amazon Has Global Aspirations for Medical-Supplies Marketplace (Bloomberg)

• The illusion of lower drug prices (Axios)
• Generic drug prices are going up, too (Axios)
• Why putting drug prices in ads is a bad idea (STAT)
• A drug maker paid Kim Kardashian $500,000 for a few social media posts. Were they worth it? (STAT-$)
• AZ hopes diabetes drug could be as effective as gastric band (pharmaphorum)
• A Novartis executive explains why the pharmaceutical industry has a 'contract with society' (Business Insider)
• FTC imposes conditions on Amneal acquisition of Impax (The Pharma Letter)
• Whistleblower Complaint, Investigation Demands and Claimed Breaches of Fiduciary Duty Are Part of the Drama Surrounding Rockwell Medical Fight (BioSpace)
• The Entropic Term is Laughing At Us (Science Translational Magazine)
• FTC Approves Final Order Imposing Conditions on Merger of Generic Drug Marketers Amneal Pharmaceuticals LLC and Impax Laboratories Inc. (FTC)
• Administrator Verma Statement on the Administration’s Action to Lower Drug Prices (CMS)

• Cause of CRISPR Failure Identified and Reversed (GEN)
• Bristol-Myers Squibb's Opdivo-Yervoy combo wins right to challenge Merck's Keytruda in rare cancer (Fierce)
• Scynexis’ new antifungal heads to phase 3 for yeast infections (Fierce)
• Scientists Find New Tricks For Old Drugs (NPR)
• artificial intelligence helps stanford researchers predict drug combinations’ side effects (Global Health News Wire)
• Recursion Receives FDA Clearance of Investigational New Drug Application to Initiate First Clinical Trial of REC-994 in Cerebral Cavernous Malformation (Press)
• UroGen Pharma Submits Investigational New Drug (IND) Application for UGN-102 (VesiGel) for the Treatment of Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC) (Press)
• FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) for the Treatment of Patients with Advanced Hepatocellular Carcinoma (Press)
• Janssen Provides Update on IMBRUVICA (ibrutinib) Phase 3 PHOENIX Trial in Newly Diagnosed Non-Germinal Center B Cell (Non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL) (Press)
• Asterias Biotherapeutics Announces Positive Outcome from Safety Review Committee for AST-VAC2; Recommends Continuation of Clinical Trial in Non-Small Cell Lung Cancer (NSCLC) (Press)
• Bioasis and BioAgilytix Announce Strategic Collaboration to Advance xB3-001, Bioasis’ Lead Investigational Candidate to Treat HER2+ Brain Cancer, to IND Submission and into the Clinic (Press)
• Phase 3 Trial of NINLARO (ixazomib) as Maintenance Therapy Met Primary Endpoint Demonstrating Statistically Significant Improvement in Progression-Free Survival in Patients with Multiple Myeloma Post-Transplant (Press)
• Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications (FDA)

• ResMed, Google’s Verily ink sleep-apnea-focused joint venture deal (MassDevice)
• The Lack Of Medical Device Security -- Accidents Waiting To Happen (Forbes)
• Cue Health reels in $45M in Series B financing for its diagnostic products (Fierce)
• MedTech booster Ajax Health reels in $120M in series B round (Fierce)
• Medtronic insulin pumps show promise for reducing hospitalizations (Minneapolis Star Tribune)
• Smart bandage prototype monitors wound, delivers medication (MobiHealthNews)
• iBeat launches watch that connects pulseless patients to help (MobiHealthNews)
• Zebra Medical Vision Announces FDA 510(k) Clearance of Its Coronary Calcium Algorithm (Press)
• Visura Technologies Receives FDA Clearance for the TEE Camera Assist Device System (Press)
• Pulse Biosciences Announces Treatment of First Patients in Study to Evaluate the Safety and Efficacy of Novel Nano-Pulse Stimulation for the Treatment of Sebaceous Hyperplasia Lesions (Press)

• Employers’ health costs are rising slowly (Axios)
• How Bundling Care Hurts The Patients Who Need It The Most (Forbes)
• Study: Medicare Advantage Cut ER Visits 33% Compared To Fee-For-Service (Forbes)
• AI crucial to value-based care, but security challenges and time constraints remain (Healthcare IT News)
• Trump Officials Slash Grants That Help Consumers Get Obamacare (NYT)
• NIH and VA collaborate to boost veterans’ access to cancer clinical trials (NIH)
• NIH researchers identify sequence leading to release of malaria parasites from red blood cells (NIH)
• Advisory Committee; Allergenic Products Advisory Committee; Renewal (FDA)
• Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal (FDA)
• Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal (FDA)

• FDA Advisory Committee Calendar

• Caught in a regulatory limbo following FDA hold, EMA spurns Advaxis’ effort to seek conditional OK (Endpoints)
• Dutch Ministry of Health: Prepare for a "Cliff Edge Brexit" (Emergo Group)
• NICE backs use of dye for brain tumour removal (PharmaTimes)
• Gov’t launches £10 antimicrobial research competition (PharmaTimes)
• Novartis agrees deal to manufacture CAR-T therapies in France (The Pharma Letter)
• EUSA Pharma sells critical care business to SERB Pharma (The Pharma Letter)
• Bitcoin 2.0: How Blockchain Companies Will Help Us Protect Our Genomic Data (Labiotech.eu)
• Akcea and Ionis Announce Approval of TEGSEDI (inotersen) in the European Union (Press)
• Angiodroid Srl Announces CE Mark for ANGIOPULSE Intra-aortic Balloon Pump (Press)
• Pixium Vision completes implantation of PRIMA in five patients with atrophic dry-AMD as expected for the feasibility clinical trial in France (Press)
• Dicerna Receives Recommendation from EMA Committee to Designate DCR-PHXC an Orphan Medicinal Product for the Treatment of Primary Hyperoxaluria (PH) in the EU (Press)
• Updated: Clinical trials for medicines: authorisation assessment performance (MHRA)
• Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use (MDA/2018/025) (MHRA)
• All Alaris and Asena GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine (MDA/2018/024) (MHRA)

• 12 top China VCs you need to know who are making a transpacific splash (Part 2) (Endpoints)
• Merck launches website specializing in infertility (Korea Biomedical Review)
• Orders for original drugs spike amid ban of Chinese valsartan (Korea Biomedical Review)

• Glenmark launches in-licensed CINV drug in India (The Pharma Letter)
• Growth challenges in Indian pharma likely to curtail aggregate growth to single digit: ICRA (Pharmabiz)

• 'We're cautiously optimistic': Promising new HIV vaccine trialled in humans (ABC News)
• iSchemaView Brings RAPID Imaging Platform to Australia and New Zealand Through Exclusive Distributor, Diagnostic Imaging Australia (Press)

• Huntington’s Treatment May Come from Fix of Broken DNA Repair Mechanism (GEN)
• Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation (ICH) Guidelines (Health Canada)
• Health Canada approves Baxter's 3-in-1 blood purification set for use in continuous renal replacement therapy and sepsis management protocols (Press)

• Physician burnout a key driver of medical errors (Reuters)
• By the numbers: Inequality impacts U.S. cancer death rates (Axios)
• Next-gen IT infrastructure: A nervous system backed by analytics and context (Healthcare IT News)
• If I'm Adopted, Should I Have DNA Testing? (Forbes)