Regulatory Focus™ > News Articles > Regulatory Recon: Good News for Boston Scientific, PCSK9 Inhibitors (16 March 2015)

Regulatory Recon: Good News for Boston Scientific, PCSK9 Inhibitors (16 March 2015)

Posted 16 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Good News for Boston Scientific, PCSK9 Inhibitors (16 March 2015)

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

In Focus: US

In Focus: International

  • Samsung submits MAA for infliximab biosimilar candidate to EMA (PBR) (BioCentury)
  • EU standards committee proposes measure to stop UDI info bottleneck (Clinica-$)
  • St. Jude's Portico TAVR gets CE mark reinstated after 'false alarm' (Fierce)
  • India Imposes Pharma Ethics Code On Medical Device Companies (Two-Four Insight) (PharmaBiz)
  • Newest American Ebola Patient Represents A Biopharma Milestone (Forbes)

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US: Pharmaceuticals and Biotechnology

  • FDA Cancels Panel’s Meeting on Merck Surgery Drug (Fierce) (PMLive) (Press) (WSJ-$) (Pink Sheet-$) (SCRIP-$) (Reuters)
  • Biosimilar Naming Is Challenge For Provider Databases (Pink Sheet-$)
  • Astellas Antifungal Nabs 12-Year Exclusivity: QIDP+Orphan Combos Are Rare (Pink Sheet-$)
  • The Role of Exploratory INDs for Translating Radiopharmaceuticals into First-In-Human Studies (PubMed)
  • Congress Takes Note of FDA's Latest Issue of a Rare Pediatric Disease Voucher (Congress) (Learn More)
  • Op-Ed: FDA should follow Europe’s lead on Indian drug suspensions (The Hill)
  • Pediatric Studies: FDA Pushes Earlier Dermatitis Trials; Will It Push Others Next? (Pink Sheet-$)
  • District court hears Amgen, Sandoz biosimilars case (BioCentury)
  • US extends use of Actavis bipolar drug to children (PharmaTimes)
  • Do Americans Want the FDA to Restrict Pain Medications or Educate Consumers on Their Use? (National Pain Report)
  • CRE Outbreak Underscores the Need for New Antibiotics (Pew)
  • Texas Bill Defines Sale of Unapproved Drugs (Scout)
  • USFDA inspects Gagillapur facility of Granules India (Business Standard)
  • Ad Industry Group Recommends That Little Remedies Stop Cold, Sore Throat Claims (PharmPro)

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

US: Pharmaceuticals and Biotechnology: General

  • How expensive medications are increasingly out of reach (Washington Post)
  • Biotech investing trends may be hurting innovation (CNBC)

US: Medical Devices

  • FDA Finally Approves Watchman Afib Device (MedPage Today) (Forbes) (Press) (Reuters) (WSJ-$) (Mass Device)
  • FDA Panel To Consider Data Shift For Pediatric Cochlear Implants (Gray Sheet-$)
  • Burgess Floats 21st Century Cures Electronic Health Records Interoperability Draft (IHP-$)
  • Selecting The Best Regulatory Path For Your Medical Device (MedDeviceOnline)
  • February 2015 510(k) Clearances (FDA)
  • Nurses Have To Translate When Medical Devices Fail To Communicate (NPR)
  • St. Jude: New CHAMPION Data Show Significant Improvement in Survival Rates for Heart Failure Patients with Reduced Ejection Fraction (Press)
  • Medtronic CoreValve Evolut R System Yields Exceptional Outcomes in First Clinical Study (Press)
  • Medtronic CoreValve System Sustains Superior Survival Benefit Over Open Heart Surgery at Two Years (Press)
  • VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.2 (Press)
  • Gauss Surgical Announces FDA 510(k) Clearance of Triton Canister App for Accurate Surgical Blood Loss Monitoring (Press)
  • Data Shows BIOTRONIK ProMRI Pacemakers Are Safe and Effective in Full-Body MRI Environment (Press)

US: Dietary Supplements

  • Jarrow: There is a NY State agenda for ‘supplement safety’ legislation (NI-USA)

US: Assorted And Government

  • FDA’s Top Two Reform Priorities Aren’t Really Legislative Material (Pink Sheet-$)
  • US Capitol Capsule: Biomedical innovation: This stuff is hard (SCRIP-$)
  • Patent office gets permanent chief after 2-year vacancy (SCRIP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • Newest American Ebola Patient Represents A Biopharma Milestone (Forbes)
  • Liberia's drop in Ebola may mean NIH trial move (SCRIP-$)

Europe

  • Samsung submits MAA for infliximab biosimilar candidate to EMA (PBR) (BioCentury)
  • EU standards committee proposes measure to stop UDI info bottleneck (Clinica-$)
  • St. Jude's Portico TAVR gets CE mark reinstated after 'false alarm' (Fierce)
  • Estonia helps Moldova get up to speed on EU drug requirements (Clinica-$)
  • Electronic Common Technical Document (eCTD) v4.0 draft EU module 1 implementation guide public consultation (EMA)
  • Certificate of Free Sale to be issued by MHRA (MHRA)
  • Distributing donated drugs a major challenge says UK neglected diseases group (Outsourcing Pharma)
  • MHRA is 1 of 10 regulators to help with the development of treatments for dementia (MHRA) (MHRA)
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0 - Step 2 (EMA)
  • Principles on assignment of defined daily dose for animals 4 (DDDA) and defined course dose for animals (DCDA) (EMA)
  • NICE system ‘slowing market access to cancer meds’ (PMLive)

India

  • India Imposes Pharma Ethics Code On Medical Device Companies (Two-Four Insight) (PharmaBiz)
  • Bar code on drug packaging to help track and trace authenticity (India Times)
  • India considers standalone pharmaceutical ministry (Fierce)
  • Health ministry okays plan to monitor medical devices; vigilance cells to be set up nationwide (India Times)

Canada

  • Implementation of Advance Notice of Importation Process Pilot for Cosmetics and Drugs (Health Canada)

Australia

  • TGA Warns About Duodenoscopes (TGA)

Clinical Trials

  • Is there an IRB inside your Phone? (Harvard BOH)
  • The Missing Pieces: A PLOS Collection of Negative, Null and Inconclusive Findings (AllTrials)

General Regulatory And Interesting Articles

  • Gas-sniffing pills could help diagnose gut diseases (CBS)
  • A Potential Contender for US President Promoting "Diabetes Cure" (NYTimes)
  • Horse dung has scientists on scent of antibiotic success (Reuters)
  • Someday, Doctors Could Prescribe You Video Games For Your Brain (BuzzFeed)
  • Can the crowd solve medical mysteries? (CNBC)
  • Designing and Manufacturing Biopharma Delivery Devices (MDDI)
  • This Chemistry 3D Printer Can Synthesize Molecules From Scratch (Popular Mechanics)

Regulatory Reconnaissance #514 – 16 March 2015

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 @AlecGaffney 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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