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

Posted 11 July 2018 | By Ana Mulero 

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

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

In Focus: US
  • 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)
In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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 (
  • 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)
Asia India
  • 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)
General Health & Other Interesting Articles
  • 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)
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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