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Recon: Drugmakers ignore Trump on promised price cuts

Posted 05 July 2018 | By Ana Mulero 

Recon: Drugmakers ignore Trump on promised price cuts

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

In Focus: US
  • Drugmakers ignore Trump on promised price cuts (Politico)
  • More than $100 Billion Spent on M&A in the First 6 Months of 2018 (BioSpace)
  • GSK director sued over US opioid epidemic (Financial Times)
  • Drugmakers try evasion, tougher negotiations to fight new U.S. insurer tactic (Reuters)
  • Mercy partners with Johnson & Johnson to evaluate medical device safety (St. Louis Business Journal-$) (Fierce)
In Focus: International Pharmaceuticals & Biotechnology
  • Zynerba Scraps Development of THC Prodrug ZYN001 after Failed Trial (GEN) (Endpoints)
  • Regeneron's CEO has been outspoken about drug price hikes, but one of his company’s drugs just got more expensive (Business Insider)
  • After a decade working for pharma, AHIP CEO Matt Eyles pegs drug pricing as his top priority (Fierce)
  • Jefferies says Gilead is poised for turnaround—and JAK inhibitor could be key (Fierce)
  • Non-opioid painkillers: agony column (Financial Times)
  • Review article: Chimeric Antigen Receptor Therapy (NEJM)
  • Biopharma has a new big idea for making cancer immunotherapy work better (STAT-$)
  • The biotech scorecard for the third quarter: 12 make-or-break industry events to watch (STAT-$)
  • Pharma is Exploring How to Maximize ICH Q12 Value in Practice; Q12 EWG Encourages Feedback (IPQ)
  • Augmented Engagement: The Future of Pharma And Health Care Marketing (Forbes)
  • Allergan Beats Challenge Over Company Stock in 401(k) Plan (Bloomberg)
  • an new data aggregators shift the balance of power away from pharma? (PMLiVE)
  • Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Data show Imnovid-based triple therapy PFS benefit in blood cancer (PharmaTimes)
  • FDA-Mandated Trials: No Excess Risk With LABA Combo in Asthma (Medscape)
  • Nobel prize winning technology reveals common herpes virus structure (MRC)
  • New England Journal of Medicine Publishes Results from Pivotal Study of TEGSEDI (inotersen) for the Treatment of Hereditary ATTR Amyloidosis (Press)
  • Kalytera Announces Pre-IND Meeting Date with FDA (Press)
Medical Devices
  • AHA, other groups call for medical device security government guidance, financial support (Healthcare IT News)
  • Natera Opens New Front in Prenatal Test Battle With Illumina (Bloomberg)
  • FDA pledges 'efficient regulation' of mobile health apps (Healthcare Dive)
  • Boston Scientific Can't Toss 800 Pelvic Mesh Suits (Law360-$)
US: Assorted & Government
  • Roe v. Wade vs. Stem Cell Study? (Bloomberg)
  • IPO Releases List of Top 300 Patent Holders for 2017 (Patent Law Weblog)
  • Americans broadly favor government funding for medical and science research (Pew Research)
  • CVS Health CEO 'surprised' by Azar's comments on drug prices (The Hill)
  • It’s time for methadone to be prescribed as part of primary care (STAT)
  • Amazon's PillPack Deal Adds Drama To Rite Aid-Albertsons Vote (Forbes)
  • The Trump administration could make fee-based doctors more affordable for seniors  (CNBC)
  • How FDA’s recall system fails consumers (Politico)
  • FDA Renews Cautions Against Consumption of Kratom Following Conclusion of Salmonella Investigation (The National Law Review)
Upcoming Meetings & Events Europe
  • Food Additives and Drugs Change Antibiotic Effectiveness (GEN)
  • Recall – SAM XT Extremity Tourniquet (MHRA)
  • Microbiome startup Nextbiotix raises €7M to tackle inflammatory bowel diseases (Fierce)
  • UK’s genome sequencing project will hit 100,000 by year-end (PharmaTimes)
  • MSD’s antiviral Prevymis fails to win NICE backing (PharmaTimes)
  • Forendo joins race to develop endometriosis drugs (pharmaphorum)
  • Review finds medical benefits of cannabis-based drugs (pharmaphorum)
  • Clovis Oncology Receives EMA Validation for its Application for a New Indication for Rubraca (rucaparib) as Maintenance Treatment for Women with Recurrent Ovarian Cancer (Press)
  • Another IPO frenzy? Two US biotechs head to Hong Kong for a public market debut (Endpoints)
  • CRISPR-Induced Mutations Give Wing to a Butterfly Effect (GEN)
  • Cellect, denovoMATRIX start stem cell research project (Fierce)
  • China's Sinovac raises $87 million and aborts plan to go private (The Pharma Letter)
  • Boehringer steps up contract manufacturing at China facility (The Pharma Letter)
  • SNUBH, Sanofi inks deal to cooperate on clinical development (Korea Biomedical Review)
  • SMC, Intel to create AI-based medical research infrastructure (Korea Biomedical Review)
  • New South Korean Guidelines for Medical Device Cybersecurity Management (Emergo Group)
  • Philips powers first tele-intensive care eICU program in Japan (Press)
  • Outcome documents of the Science Board (PMDA)
  • ICH Assembly in Kobe, Japan, 2 to 7 June 2018 (Swissmedic)
  • Xu Jinghe,Deputy Commissioner of CNDA,attends the China US Conference on the Development and Evaluation of Oncology Drugs (CFDA)
  • Pharma companies throng Gujarat to set up new units (Times of India)
  • Central aid package to help medical device parks set up common facilities; Rs.100 crore budgeted for 2018-20 (Pharmabiz)
  • CDSCO sets up panel to weigh ‘trace and track’ mechanism for top 300 drug brands, report expected in 4 months (Pharmabiz)
  • Modi Rushes to Insure Half a Billion Indians Before Election (Bloomberg)
  • Anavex sets up trial of ‘triple-action’ Alzheimer’s drug (PMLiVE)
Canada General Health & Other Interesting Articles
  • Maintaining healthy vision may help keep brain in shape, too (Reuters)
  • Carrot, a Silicon Valley startup, takes a novel approach to funding IVF (The Economist)
  • What Happens When You See The Same Doctor? Link With Lower Death Rates (Forbes)
  • Alfred Alberts, Unsung Father of a Cholesterol Drug, Dies at 87 (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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