Regulatory Focus™ > News Articles > 7 > Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

Posted 18 July 2018 | By Ana Mulero 

Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

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

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In Focus: International
  • Medical devices woes weigh on British conglomerate Smiths Group (Financial Times) (Reuters)
  • Hikma acts to ease critical shortage of pain meds in USA (The Pharma Letter) Reuters)
  • AstraZeneca to stockpile drugs for Brexit (BBC News) (The Telegraph) (Reuters)
  • China heart drug sold globally may have had impurity since 2012 (Reuters) (Newsweek)
  • J&J Unit to Sell Sylvant Rights to U.K. Drugmaker Eusa Pharma (Bloomberg) (The Pharma Letter)
  • Takeda Bets on China for Global Growth (Bloomberg)
  • Ovid, Takeda add 2 rare epilepsies to rare drug pact (Fierce)
  • U.N. says global fight against AIDS is at 'precarious point' (Reuters)
  • GE Health, Change Healthcare, Medtronic to Receive Israeli Government Grant (CTech)
  • Funding gaps threaten closure of health facilities serving almost one million vulnerable Iraqis (WHO)
Pharmaceuticals & Biotechnology
  • Biotech IPO Boom Comes With Side Effects (WSJ)
  • The News on Drug Prices? Nothing Good (NYT)
  • McKesson, Cardinal Health Must Face New York Opioid Suits (Bloomberg)
  • Senate Eyes Drug Treatment Record Privacy Changes (Bloomberg-$)
  • New challenge filed to CRISPR patent licensed by Editas Medicine (STAT-$)
  • Boston-area companies bet on antibiotic development, even as big drug makers step back (STAT-$)
  • Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act (Scrip-$)
  • Boom time: Rubius, Crinetics find big support in upsized IPOs totaling $343M raise (Endpoints)
  • Startup Neuraly Launches with $36 Million: Targets Neurodegenerative Diseases (BioSpace)
  • Boehringer exercises option to license novel TCRm antibodies (The Pharma Letter-$) (Press)
  • Where does J&J's new drug fit in the crowded HIV market? (BioPharma Dive)
  • Appeals court rejects hospital industry’s challenge on 340B changes (STAT)
  • Administrator Verma Statement on Recent 340B Court Decision (CMS)
  • Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA Uses New Process to Approve Ribociclib Extensions (Medscape) (FDA)
  • Eisai obesity drug Belviq may have an edge with new heart safety data—but to what end? (Fierce)
  • Roche's Tecentriq extends its hot streak with liver cancer combo breakthrough (Fierce)
  • Type 2 diabetes research: fewer side effects from modified medication (pharmaphorum)
  • Broadly acting antibodies found in plasma of Ebola survivors (NIH)
  • Issuance of Priority Review Voucher; Rare Pediatric Disease Product to GW Research (FDA)
  • Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma (Press)
  • FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer (Press)
  • Catalyst Biosciences Announces Positive Interim Data from a Phase 2/3 Study of Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors (Press)
  • CTI BioPharma Announces Pacritinib Program Update Following Type B Meeting with U.S. FDA (Press)
  • Adaptimmune Announces Favorable Review of Safety from One Billion Cell Dose Cohort in MAGE-A10 SPEAR T-cell Study and Initiation of Third Dosing Cohorts (Press)
  • Data to be Presented From Biogen’s Alzheimer’s Disease Clinical Development Portfolio at the 2018 Alzheimer’s Association International Conference (AAIC) (Press)
  • Biogen receives FDA orphan drug designation for treatment of spinal muscular atrophy (FDA)
  • Puma Biotechnology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Neratinib HER2 Mutation Basket Study (SUMMIT Trial) (Press)
  • Poxel Announces Favorable Results for PXL770 Phase 1b Multiple Ascending Dose Trial and Drug-Drug Interaction Study (Press)
Medical Devices
  • Cook Medical touts launch, first use of Advance CS, Compass CT systems (DDBN)
  • Why a Melanoma Blood Test Would Be Such a Big Deal (Fortune)
  • Genetic testing is coming of age, but for consumers it's buyer beware (CNBC)
  • Polares raises $25M to bring its 'hemi-replacement' mitral valve to the clinic (Fierce)
  • Diassess to get up to $21.9M from the feds to develop its at-home flu diagnostic (Fierce)
  • FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion (Press)
  • Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage) (Press)
  • Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody. (Press)
  • Spectral Announces Successful Manufacturing Audit of Toray by the US FDA (Press)
  • Adaptiiv Receives FDA 510(k) Clearance to Market 3D Bolus Software (Press)
US: Assorted & Government
  • Insurers are helping shape the future of our health care system (STAT)
  • Cyberattacks on Health-Care Providers Are Up in Recent Months (Bloomberg)
  • NIH and Prostate Cancer Foundation launch large study on aggressive prostate cancer in African-American men (NIH)
  • Overcoming health-care challenges by moving from volume to value (The Hill)
  • ONC opens innovation contest for Certified Health IT Product List data (Healthcare IT News)
  • LabCorp goes down after network breach, putting millions of patient records at risk (Healthcare IT News)
  • No exclusive deal, no problem: Quest and LabCorp shares surge on optimism (CNBC)
  • Big money rolls in as GOP challenger pressures Democratic Sen. Bob Menendez for his traditionally safe seat in New Jersey (CNBC)
  • FDA Updates Patent Listing Disputes (Lachman Consultants)
  • CDx Diagnostic, Inc. v. United States Endoscopy Group, Inc. (S.D.N.Y. 2018) (Patent Law Weblog)
Upcoming Meetings & Events Europe
  • NICE calls for quicker treatment of kidney stone patients in pain (PharmaTimes)
  • Record numbers taking part in life sciences industry research (PharmaTimes)
  • OD-OS claims European ophthalmic-laser patent win over Iridex (MassDevice)
  • Co-Diagnostics Completes Submission of CE Mark Registration for Tuberculosis Screening Test (Press)
Asia
  • Pre-revenue vaccine developer CanSino lines up at a buzzing HKEX (Endpoints)
  • Home DNA Testing Starts to Gain Ground in Japan’s Aging Society (Bloomberg-$)
  • Joint R&D program to test Keytruda combo in breast cancer patients (Korea Biomedical Review)
  • Novo Nordisk Korea gets nod for diabetes drug Fiasp (Korea Biomedical Review)
  • MHLW to Introduce Guidelines for Sales Reps’ Activities, Calling for the Creation of Supervising Offices (Pharma Japan)
India
  • Amazon to invest in Indian Pharma brand MedPlus (BioSpectrum)
  • Govt grants four-month relaxation to Tramadol manufacturers and exporters to clear the existing stock (Pharmabiz)
Australia
  • Intragastric balloon systems: TGA product safety review (TGA)
  • Sodium glucose co-transporter 2 inhibitors: Safety advisory - diabetic ketoacidosis and surgical procedures (TGA)
  • A$50 million to provide life-saving support to cancer patients in Australia (The Pharma Letter-$)
Canada
  • Are opioid deaths reducing our average life expectancy? Canada now investigating (Global News)
  • Health Canada is ordered to provide clinical trial data on several medicines to a researcher (STAT-$)
  • Panther Medical Canada Inc. Opens in Canada Bringing State of the Art, Clinically Proven, Economically Viable Laparoscopic Surgical Solutions, while Saving Tax Payers Millions in Health Care Costs (Press)
General Health & Other Interesting Articles
  • What Can Odd, Interesting Medical Case Studies Teach Us? (NYT)
  • The Startup Selling Generic Viagra and Rogaine to the Instagram Crowd (Bloomberg)
  • Hospitals up the ante for medical transcription tools as vendors modernize with automation, voice recognition (Healthcare IT News)
  • How to put your medical history on your iPhone in less than 5 minutes (CNBC)
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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