Regulatory Recon: EMA Recommends 10 New Drugs for Approval (26 June 2015)

Posted 26 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • CDER Breakthrough Therapy Program: What Happens Post-Designation? (FDA)
  • New FDA Untitled Letter to BioDlogics Over Facility Inspection (CBER)
  • Many CMC Deficiencies Can Be Easily Corrected, FDA Finds (Gold Sheet-$)
  • FDA Prepares to Refuse ANDAs with Incomplete Impurity Profiles (Gold Sheet-$)
  • Firms From Which State Have the Fastest PMA Approvals? (MDDI)
  • SEC Actions Stir Concerns Over Compliance Officer Liability (WSJ-$)

In Focus: International

  • EMA Recommends 10 New Medicines for Use (EMA)
  • EC: We Don't Plan on Using Compulsory License Against Sovaldi (EC)
  • TxCell halts drug production, a decision made with French regulator (Fierce)
  • Indian Investors Turn Cautious On Compliance Concerns (PharmAsia-$)
  • Trial data: charity hits back at CRO's anti-transparency bid (Outsourcing Pharma)

US: Pharmaceuticals and Biotechnology

  • CDER Breakthrough Therapy Program: What Happens Post-Designation? (FDA)
  • New FDA Untitled Letter to BioDlogics Over Facility Inspection (CBER)
  • Many CMC Deficiencies Can Be Easily Corrected, FDA Finds (Gold Sheet-$)
  • FDA Prepares to Refuse ANDAs with Incomplete Impurity Profiles (Gold Sheet-$)
  • FDA Urged to Explain ANDA Deficiencies to Avoid RTR Errors (Gold Sheet-$)
  • Roche's Lucentis Could Get Boost From House Compounding Directives To FDA (Pink Sheet-$)
  • FDA, Big Data and Drug Safety (RUF)
  • Lessons from ISPE Quality Metrics Pilot: Start Small and Be Aware of Costs (Gold Sheet-$)
  • FDA Enforcement of Digital Communications – An Update (Eye On FDA)
  • Pharmacy Groups Want More Time to Comply With DQSA (Letter-PDF) (FDA Law Blog)
  • Unions accuse Novartis of 'sham' patent fight to delay Sun's Gleevec generics (Fierce)
  • National "Right To Try" Website Launches (Press) (Website)

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

  • CSL Behring supports hemophilia BLA with Phase III data (SCRIP-$) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • ​​California Lawmakers Vote To Remove Vaccine Exemptions For Schoolchildren (NPR) (NYTimes)
  • Celgene May Seek Sanctions Against Kyle Bass Over Patent Challenges (Pharmalot)

US: Medical Devices

  • Firms From Which State Have the Fastest PMA Approvals? (MDDI)
  • Class 1 Recall for Disetronic's Insulin Infusion Pump (FDA)
  • Black market butt injections: dangerous and deadly (CNN)
  • Exactech Receives FDA 510(K) Clearance for Its Optetrak Logic Constrained Condylar Prosthesis (Press)
  • Caldera Medical Announces FDA Clearance for New Generation of Vertessa® Lite Polypropylene Mesh for Sacrocolpopexy (Press)

US: Assorted And Government

  • SEC Actions Stir Concerns Over Compliance Officer Liability (WSJ-$)

Upcoming Meetings and Events

Europe

  • EMA Recommends 10 New Medicines for Use (EMA)
  • EC: We Don't Plan on Using Compulsory License Against Sovaldi (EC)
  • Better training tools recommended to support patients using adrenaline auto-injectors (EMA)
  • AbbVie's HUMIRA (Adalimumab) Receives Positive CHMP Opinion to Treat Adult Patients with Active Moderate to Severe Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease (EMA) (Press)
  • Novartis's Farydak Recommended By CHMP For EU Approval To Treat Multiple Myeloma (RTT) (EMA)
  • Alexion Receives CHMP Positive Opinions for Strensiq (asfotase alfa) and Kanuma (sebelipase alfa) in the European Union (Press) (EMA)
  • EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency (EMA)
  • Positive opinion for Santhera's orphan drug Raxone in Europe (SCRIP-$) (Press)
  • Daiichi Sankyo gets EU OK for Lixiana anticoagulant (PMLive)
  • MHRA helps Fujifilm future proof manufacturing facility - one of the first in Europe (MHRA) (Outsourcing Pharma)
  • TxCell halts drug production, a decision made with French regulator (Fierce)
  • BioMarin Announces EMA Validates MAA for Drisapersen for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping (Press)
  • Biogen and Sobi Announce European Medicines Agency Validates ALPROLIX (rFIXFc) Marketing Authorization Application (Press)
  • Amicus Therapeutics Announces Galafold Marketing Authorization Application (MAA) Validated by European Medicines Agency (Press)
  • UK Court weighs in on Lilly-Actavis Alimta case (Pharmafile)
  • Masimo's MightySat Rx Pulse Oximeter Cleared in Europe (medGadget)
  • Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2014 (EMA)

India

  • Indian Investors Turn Cautious On Compliance Concerns (PharmAsia-$)
  • Health Canada requests quarantine of drug products from Polydrug Labs due to data integrity concerns (Press)

Japan

  • Bayer Receives Approval for EYLEA for the Treatment of Retinal Vein Occlusion in Japan (Press)

Canada

  • Development of a Regulatory Framework for Mandatory Reporting by Healthcare Institutions (Vanessa's Law) (Health Canada)

Clinical Trials

General Regulatory And Interesting Articles

Regulatory Reconnaissance #584 – 26 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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