Regulatory Focus™ > News Articles > 7 > Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts

Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts

Posted 19 July 2018 | By Ana Mulero 

Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts

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In Focus: US Advertisement: Introducing BSI's Fall Medical Device Roadshow
Join leading global medical device Notified Body/ISO 13485 registrar BSI's full day Roadshow for our current experiences, best practices and latest expectations of the European MDR and quality assurance requirements. Topics include MDR implementation limitations, clinical requirements, labelling and UDI, technical documentation best practices, MDSAP, ISO 14971 application and the Quality Management System (QMS) aspects of the MDR. Click here for full agenda, dates and locations.
In Focus: International
  • Fosun Is Said to Consider $500 Million India IPO of Gland Pharma (Bloomberg)
  • Astellas Is Considering Selling Europe Assets to Raise Cash (Bloomberg)
  • European Drug Innovators Face Tough Fight to Maintain Research Incentives (PharmExec)
  • EU mulls coal, pharma, chemicals tariffs if US hits cars: Wiwo (Reuters)
  • Ebola Eludes Drug Testing Once More as Outbreak Tapers Off (Bloomberg-$)
  • Australian Regulators Plan Improved Patient Access, Reimbursement for Prosthetic Medical Devices (Emergo Group)
Pharmaceuticals & Biotechnology
  • Big Pharma is quietly using nonprofits to push opioids (Los Angeles Times)
  • Smart Bandage Can Dispense Drugs, While Keeping An Eye On Your Wound (Forbes)
  • Interchangeable Biosimilars: The Central Path to Lower Biologic Prices? (Focus)
  • Stripped-down Vical ‘considering options’ after pipeline woes (Fierce)
  • Gritstone, Bristol-Myers Squibb to trial immunotherapy combos in solid tumors (Fierce)
  • From Patient Advocates to Pharma, Groups Weigh in on Trump Blueprint for Drug Costs (AJMC)
  • Report Finds Ohio Paid $224 Million More For Medicaid Drugs Than Middlemen (WOSU)
  • Ipsen and BioLabs to launch shared working space in the USA (The Pharma Letter-$) (Press)
  • Generic, Biosimilar Makers’ Dual Patent Contests Still Safe (Bloomberg-$)
  • CVS-Aetna Deal Could Drive Drug Coverage Increase in Places (Bloomberg-$)
  • Allergan Awarded $27K In Sanctions In Compounding Suit (Law360-$)
  • Association of Lowering Default Pill Counts in Electronic Medical Record Systems With Postoperative Opioid Prescribing (JAMA)
  • Illegal Abortion Will Mean Abortion By Mail (The Atlantic)
  • Lawmakers reject bids to incentivize development of new antibiotics (STAT-$)
  • Cleveland Clinic joins forces with Case Western in biomedical engineering deal (Healthcare IT News)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • MFIA, CRIT Sue Government Over Clinical Trial Data (Yale Law School)
  • The Risks and Benefits of Expedited Drug Reviews (JAMA)
  • Could synthetic Botox soothe chronic pain? A new study holds out the possibility (STAT)
  • Archived chat: Breaking down Amarin’s highly anticipated REDUCE-IT trial (STAT-$)
  • New Phase 3 Data Show Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis (Press)
  • ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 2018 (Press)
  • Asana BioSciences Initiates Phase 2b Study of ASN002 in Patients with Moderate-to-Severe Atopic Dermatitis (RADIANT) (Press)
  • Boehringer Ingelheim and Lilly announce Trajenta’s CARMELINA cardiovascular outcome trial met its primary endpoint (Press)
  • Ocular Therapeutix  Announces FDA Acceptance of NDA Resubmission for DEXTENZA (Press)
Medical Devices
  • FDA Panel To Ponder Down-Classifying HIV Tests (Medtech Insight-$)
  • B Braun inks deal to buy NxStage’s bloodlines biz (MassDevice)
  • Candela Announces FDA Clearance Of Vbeam Prima (Press)
  • Foundation Medicine and Guardant Health Agree to Settle Patent Infringement Lawsuit (Press)
  • Medtronic Clinical Trial to Evaluate ECG Belt for Optimizing Heart Failure Therapy (Press)
  • Corindus Announces Significant Progress in the Development of Remote Vascular Robotic Technology with the CorPath GRX System (Press)
  • New Study Validates Neoteryx’s VAMS Technology for at-Home Blood Collection in Monitoring HbA1c Levels of Diabetic Children (Press)
US: Assorted & Government
  • IBM and the VA extend their Watson collaboration in guiding veterans’ cancer treatments (Fierce)
  • The medical community is changing its mind on chronic fatigue syndrome. Why aren’t insurers? (STAT)
  • Mobile Device Data Could Speed Drug, Device Approvals: FDA (Bloomberg-$)
  • Trump loyalists at VA shuffling, purging employees before new secretary takes over (The Washington Post)
  • CMS plots path forward for Kentucky work requirements after court setback (Politico)
  • Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period (FDA)
  • Metered Dose Inhaler and Dry Powder Inhaler Drug Products--Quality Considerations; Draft Guidance for Industry; Reopening of the Comment Period (FDA)
  • Soldiers test Army's newest transport telemedicine technology (U.S. Army Medical Materiel Agency Public Affairs)
Upcoming Meetings & Events Europe
  • UK urges Vertex to accept ‘generous’ Orkambi funding offer (pharmaphorum)
  • European Union: Your Web Doctor will see you now - software as a medical device (Lexology)
  • Non-mutagenic impurities: more guidance needed on safety-based limits (EPR)
  • Nemaura Places SugarBEAT Manufacturer Order for UK Commercial Launch (Press)
  • Kolon Life Science inks deal to sell Invossa to China (Korea Biomedical Review)
  • Seoul allows use of marijuana-based drugs for incurable diseases (Korea Biomedical Review)
  • Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China (JAMA)
  • Indian Pharma: Think beyond mere price control (Financial Express)
  • Exclusive: India Life Sciences Fund backs drug distributor in new pharma bet (Times of India)
  • Industry welcomes govt decision to provide Tramadol manufacturers & exporters 4-month relaxation to comply with NDPS Act (Pharmabiz)
  • Dying to Survive: Indian generic medicines have a tale to tell (Business Today)
  • Mental health beds must increase in SA, says state coroner (ABC News)
  • Canada could decriminalize personal drug possession — but here’s why it’s unlikely (Global News)
  • What does it take to get a drug approved by Health Canada? (Medical News Bulletin)
General Health & Other Interesting Articles
  • The Status of End-of-Life Care in the United States (JAMA)
  • Hospitals Are Learning To Source For Themselves -- Finally (Forbes)
  • CEO Gawande’s first task: a road trip to hear firsthand about workers’ health challenges (STAT)
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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