Regulatory Recon: Medicines Co. Snags Long-Sought Approval for Cangrelor (23 June 2015)

Posted 23 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Europe bans some APIs from Chinese drugmaker Zhuhai United (Fierce)
  • EU consortium names providers of pharma verification repository (Securing Industry)
  • EUnetHTA Launches Public Consultation of Hepatitis C Treatments (EUnetHTA)
  • CDSCO drug inspectors soon to get online training on cGMP (PharmaBiz)
  • USFDA wants closer cooperation with Indian drug regulators (Bloomberg)
  • Biosimilars are safe, Australian government tells the public (SCRIP-$) (Fierce) (Biosimilar News)
  • ICH Addresses API Makers' Uncertainties With Q7 Q&A Guide (FDAnews-$)

US: Pharmaceuticals and Biotechnology

  • FDA approves Medicines Co's blood clot drug after a decade (Reuters) (Fierce) (MedPageToday) (BioCentury) (SCRIP-$) (Pink Sheet-$) (PMLive) (FDA) (Press)
  • Generic Firms Fear 'New Lifecycle Management Tool' From FDA Pill Size Guidance (Pink Sheet-$)
  • FDA to Hold Patient-Focused Drug Development Meeting on Hungtington's, Parkinson's (FDA) (BioCentury)
  • Pharmaceutical companies use software to cut cost of clinical trial drugs (ComputerWeekly)
  • Why FDA is evaluating patient-reported AE data from PatientsLikeMe (BioCentury-$)
  • Should FDA Have the Authority to Release CRLs? (FDA Law Blog)
  • Pediatric post-marketing safety systems in North America: assessment of the current status (PubMed)
  • OPDP Sends Six Enforcement Letters in Six Months (CHC)
  • FDA Says Generic Abilify Still OK to be Marketed (FDA)
  • Court Again Rejects Alleged 'Fraud on the FDA' Theory of Implied Certification Liability (National Law Review)
  • National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table (HHS)
  • Texas Governor Abbott Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines (Press)

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

  • Valeant and Progenics Announce the Submission of U.S. New Drug Application for Oral RELISTOR (Press)
  • Breakthrough anti-anticoagulants from Boehringer, Portola post stellar PhIII data (Fierce) (PharmaTimes)
  • Vical shares decimated (again) after herpes vaccine flunks a PhI/II trial (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • ​​New Formula Aims to Help Weigh Value of Cancer Treatments (WSJ-$) (SCRIP-$) (NYTimes) (Pink Sheet-$) (Fierce)
  • Attorney: ​Supreme Court's Spider-Man ruling could help biotech, tech deals (BioFlash) (SCRIP-$)
  • Fraud Still Plagues Medicare Drug Program, Watchdog Finds (ProPublica)
  • California Man Pleads Guilty in Prescription Drug Diversion Scheme (DOJ)

US: Medical Devices

  • Medtronic Announces FDA Approval for New TAVR System (Press)
  • Siemens snags FDA approval for HIV combo test (Fierce)
  • Silos and Software in Medical Devices (MDS)
  • Surgical Energy-Based Device Injuries and Fatalities Reported to FDA (PubMed)
  • Second Sight Announces Positive Long-Term Results of the Argus II Retinal Prosthesis System (Press)
  • Torax Medical Announces FDA Approval of a New LINX Device Compatible with 1.5 Tesla Magnetic Resonance Imaging (MRI) Systems (Press)

US: Assorted And Government

  • 21st Century Cures Act Drops Controversial Funding Source (IHP-$)
  • Rule Change Bars Chimpanzees from use in Clinical Trials (FWS)
  • Senator Warren holds roundtable discussions in Boston with FDA Acting Commissioner Dr. Stephen Ostroff and members of MassMEDIC and MassBio (Press)
  • SCOTUS Orders Just Compensation for a Regulatory Taking: Agency Regulations Could Endanger the Public Fisc (FedReg Advisor)

Upcoming Meetings and Events

Europe

  • Europe bans some APIs from Chinese drugmaker Zhuhai United (Fierce)
  • EU consortium names providers of pharma verification repository (Securing Industry)
  • EUnetHTA Launches Public Consultation of Hepatitis C Treatments (EUnetHTA)
  • Big Reshuffle in the Works as DG Sante (Politico)
  • Orphacol ruling bolsters EU orphan exclusivity rules (SCRIP RA-$)

India

  • CDSCO drug inspectors soon to get online training on cGMP (PharmaBiz)
  • USFDA wants closer cooperation with Indian drug regulators (Bloomberg)

Australia

Other International

  • ICH Addresses API Makers' Uncertainties With Q7 Q&A Guide (FDAnews-$)
  • New Medical Device Barcodes Required by Saudi Regulators (Emergo)
  • A New Safety Engineer's Perspective on Standards (MDDI)

General Regulatory And Interesting Articles

  • In twist, scientists join tobacco companies to fight cancer (Reuters)
  • The end of animal testing? Human-organs-on-chips win Design of the Year (Guardian)
  • Many with early breast cancer have too many imaging tests (Reuters)

Regulatory Reconnaissance #581 – 23 June 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.

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