Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Uptravi for Pulmonary Arterial Hypertension, CMS Dashboard Highlights

Regulatory Recon: FDA Approves Uptravi for Pulmonary Arterial Hypertension, CMS Dashboard Highlights Rising Drug Costs (22 December 2015)

Posted 22 December 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Uptravi for Pulmonary Arterial Hypertension, CMS Dashboard Highlights Rising Drug Costs (22 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves new orphan drug to treat pulmonary arterial hypertension (FDA) (MNT)
  • Safety Outsourced Under Bill Blessed by FDA, Medical Device Makers (Bloomberg) (MassDevice)
  • Surge in Prescription Costs Hit Medicare in 2014 (WSJ) (Politico) (The Hill) (PhRMA) (CMS)
  • Why a Drug to Prevent HIV Infection Is in Low Demand (WSJ)
  • First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016 (CardioBrief)
  • FDA Enforcement: Protecting Consumers and Enhancing Public Confidence (FDA Voice)

In Focus: International

  • China FDA Restructures Medical Device Adverse Event Regulations (National Law Review)
  • Companies like Sun Pharma and Dr Reddy's under USFDA lens, domestic drug firms may face more scrutiny (Economic Times)
  • BSI Recognized as Accredited Auditor under MDSAP Program in Brazil (MassDevice) (ANVISA)
  • Russian drugmakers to challenge provision of additional patents on original drugs (PharmaLetter-$)
  • Malaysia Consults On Procedures For Issuing Medtech Establishment Licenses (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA's Strategic Retreat In Off-Label Case: Concedes Broader Use of Exparel, Gets Firm To File sNDA (RPM Report-$)
  • The future of the FDA and drug regulations (PharmaPhorum)
  • Independent group says new Glaxo asthma drug far too expensive (Reuters)
  • FDA overturns 30-year ban on blood donations by gay men (Reuters) (Washington Post) (Focus)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Adaptimmune announce initiation of study to evaluate affinity enhanced T-cell therapy targeting MAGE-A10 in patients with non-small cell lung cancer (MNT)
  • Pfizer Reports Top Line Results from a Phase 3 Study Evaluating Desvenlafaxine Succinate Sustained-Release Formulation in Pediatric Patients with Major Depressive Disorder (Press)
  • Merck KGaA, Darmstadt, Germany and Pfizer Advance Clinical Development Program with Two Additional Phase III Trials of Avelumab (Press)

US: Medical Devices

  • For AirXpanders, a switch from 510(k) to de novo was no big deal (MassDevice)
  • FDA Approves BIOTRONIK Iperia ICD Systems with Full-Body ProMRI Technology (Press)
  • Materialise Receives FDA NSE Letter for X-Ray 510(k) Submission (Press)
  • Jintronix gets validation for FDA-cleared remote monitoring tools for physical therapy (MedCityNews)
  • GI Logic gets FDA clearance for connected wearable stethoscope (mobihealthnews)

US: Assorted and Government

  • J&J Found Liable In 1st Philly Pelvic Mesh Case (Law360-$)
  • New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate (Federal Register)
  • Florida pill mill crackdown also may have curbed heroin deaths, researchers find (Washington Post)

Upcoming Meetings and Events              

Europe

  • Will Your Current Conformity Assessment Certs Remain Valid As Long As You Hope? (Clinica-$)
  • IQWiG finds no hint of added benefit for Amgen's Repatha (PharmaLetter-$)
  • XENiOS® Will Seek Regulatory Approval for i-lung (Press)
  • Drug company's advisory board meeting 'breached industry code' (Pharmaceutical Journal-$)
  • Pharmaceutical industry announces financial agreement with the Department of Health to help fund NHS's 2016 medicines bill (ABPI)
  • CSL Behring Submits Marketing Authorization Application to EMA for rVIII-SingleChain for Patients with Hemophilia A (Press)

India

  • 'No government firm under pharma department produces cancer drugs' (Economic Times)
  • Generic Harvoni (Ledipasvir And Sofosbuvir) Indian Market Formation (24 Insight)
  • India pharma investors think small as U.S. compliance woes hit heavyweights (Reuters)
  • Aurobindo Pharma gets USFDA nod for its conjunctivitis drug (Economic Times)
  • Glenmark gets USFDA final nod for anti-bacterial drug Zyvox (Economic Times)

China

  • BeyondSpring Pharmaceuticals Granted CTA by CFDA to Initiate China Arm of Global Phase III Trial of Lead Asset Plinabulin (Press)

Japan

  • Pluristem secures Japan's PMDA nod on regenerative drug trial protocol (BioSpectrum)
  • CSL Behring seeks Japan PMDA approval for Hemophilia drug (BioSpectrum)

Canada

  • Canada clears Medtronic Evera MRI SureScan ICD (MassDevice)

Australia

  • OTC new medicines registration process (TGA)
  • Process to change a registered OTC medicine (TGA)
  • Advertising health services with medical devices (TGA)
  • Medicines Australia CEO Resigns After A 'Challenging' Year (SCRIP-$)

General Health and Other Interesting Articles

  • International study reveals new genetic clues to age-related macular degeneration (NIH)
  • Drink to Your Health (in Moderation), the Science Says (NYTimes)
  • U.S. Ebola survivors deal with multiple health issues, including depression (Washington Post)
  • Homeopathic drugs: No better than placebos? (Washington Post)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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