Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves New Vaccine, Eye Drug (26 March 2015)

Regulatory Recon: FDA Approves New Vaccine, Eye Drug (26 March 2015)

Posted 26 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approves New Vaccine, Eye Drug (26 March 2015)

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

In Focus: US

  • FDA again expands usage of Regeneron eye drug Eylea (Reuters) (FDA) (PharmaTImes) (BioCentury) (SCRIP-$)
  • FDA OK for Sanofi's Quadracel vaccine (PharmaTimes) (PharmPro)
  • Otsuka Sues FDA Over “Corrected” ABILIFY Approval; Alleges Violation of the Most Fundamental Precept of FDA’s Statutory Drug Approval Authority (FDA Law Blog)
  • Slower FDA Review Divisions Draw Attention At Senate Hearing (Pink Sheet-$)
  • Study: Most Pharmacists ID Biologics by Their National Drug Code—Not Their Name (AMCP)
  • CDER's Assessment of its Regulatory Science Needs (FDA)
  • FDA Shows Displeasure with Leasing 510(k)s (Arnall Golden Gregory)
  • FDA Petitioned to Withdraw Approval for Essure (FDA)

In Focus: International

  • French revolution: committee OKs off-label Avastin in AMD (SCRIP RA-$) (ANSM)
  • Regenerative medicine experts call on UK MHRA to press for EU-wide regulatory changes (SCRIP RA-$)
  • Human factors engineering initiative likely to result in guidance, says UK expert (Clinica-$)
  • GMP for excipients: new EU rules on raw materials, packaging, tracking (In-Pharma)
  • Guinea becomes launching pad for Merck Ebola vax study (BioPharmaDive) (SCRIP-$)
  • Pharmacy Students Should be Trained in Regulatory Affairs, Says Head of Pharma Group (PharmaBiz)
  • Japan's MHLW approves Gilead's Sovaldi for genotype 2 chronic hep C (Fierce)
  • AHWP's New Playbook on Harmonizing Medical Device Regulations (AHWP)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. Register for the 1 April 2015 program here.

US: Pharmaceuticals and Biotechnology

  • FDA again expands usage of Regeneron eye drug Eylea (Reuters) (FDA) (PharmaTImes) (BioCentury) (SCRIP-$)
  • FDA OK for Sanofi's Quadracel vaccine (PharmaTimes) (PharmPro)
  • Otsuka Sues FDA Over “Corrected” ABILIFY Approval; Alleges Violation of the Most Fundamental Precept of FDA’s Statutory Drug Approval Authority (FDA Law Blog)
  • Slower FDA Review Divisions Draw Attention At Senate Hearing (Pink Sheet-$)
  • Study: Most Pharmacists ID Biologics by Their National Drug Code—Not Their Name (AMCP)
  • CDER's Assessment of its Regulatory Science Needs (FDA)
  • Amgen to appeal rejection of bid to block Novartis biosimilar drug (Reuters) (BioCentury)
  • Ariad, Execs Beat Fraud Suit Over Failed Leukemia Drug (Law 360-$) (SCRIP-$) (Press)
  • FDA Plans Study to ID Groups Influential in Use of Generic Drugs (FDA)
  • Surrogate Marker Has to Suffice for Idiopathic Pulmonary Fibrosis, FDA Says (Medscape) (NEJM)
  • Background Analysis: US FDA Advisory Committee to Discuss the Development and Licensure of Ebola Vaccines (Tarius)
  • FDA Defends Time Needed To Finalize a Draft Guidance (Pharmalot)
  • Should the FDA crack down on homeopathic “remedies”? (Science-Based Medicine)

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

  • Conatus Pharma's liver drug succeeds in mid-stage study (Reuters)
  • Pacira Announces Data Reinforcing Benefits of EXPAREL for Postsurgical Pain Control Following Total Hip and Knee Replacement Surgery (Press)
  • Genzyme's ENCORE Clinical Data Suggest Treatment with Oral Maintenance Therapy Effective in Previously Treated Gaucher Disease Patients (Press)
  • Agios Pharmaceuticals Announces Orphan Drug Designation of AG-348 for Treatment of Pyruvate Kinase Deficiency (Press)
  • Marinus Pharmaceuticals' Ganaxolone Receives FDA Orphan Drug Designation in PCDH19 Female Epilepsy (Press)
  • OvaScience will reveal first-ever clinical data on fertility treatment this week (BioFlash)
  • Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma (Press)

US: Pharmaceuticals and Biotechnology: General

  • San Francisco may be First Major U.S. City With a Drug-Take Back Program (Pharmalot)
  • West Virginia Prescription Drug Advertising Expense Reporting Rule Repealed (Policy and Medicine)
  • Bill Would Exempt Marijuana's Active Ingredients from DEA Definition of Marijuana (Congress)
  • The lives vaccines have saved in the US, in one chart (Vox)
  • Walgreen, Others Sue Over Alleged Aggrenox Pay-For-Delay (Law 360-$)
  • Science, Patients Driving Rare Disease Drug Research Surge (AP)
  • A Look at Some Key Statistics on Rare Diseases in the U.S. (AP)

US: Medical Devices

  • FDA Shows Displeasure with Leasing 510(k)s (Arnall Golden Gregory)
  • FDA Petitioned to Withdraw Approval for Essure (FDA)
  • At CDx Harmonization Meeting, Drugmakers Take First Step At Exploring Test Differences (GenomeWeb)
  • Wright Medical wins FDA nod for Salvation external fixation device (Mass Device)
  • FDA Clears Stryker's Mako Robot To Treat Total Hip Replacement (Gray Sheet-$)
  • App-based vision test gets second FDA clearance, remote trial with Scripps, Roche (MobiHealthNews)
  • Stryker Spine Receives FDA Clearance for New Lumbar Plating System (Press)

US: Dietary Supplements

  • UNPA, AHPA move to ban sale of powdered caffeine among members (NI-USA)

US: Assorted And Government

  • Trans-Pacific Partnership Seen as Door for Foreign Suits Against U.S. (NYTimes)
  • HHS Advisory Committee Develops Recommendations on Pediatric, Privacy and Harmonization Issues in Research (Tarius)
  • Which Records must be kept according to FDA´s cGMP Guide? (ECA)

Upcoming Meetings and Events

Ebola Outbreak

  • Guinea becomes launching pad for Merck Ebola vax study (BioPharmaDive) (SCRIP-$)
  • Hemispherx Biopharma Receives Positive Opinion On Application For Orphan Designation By The European Medicines Agency For Ampligen To Treat Patients With Ebola Virus Disease (Press)

Europe

  • French revolution: committee OKs off-label Avastin in AMD (SCRIP RA-$) (ANSM)
  • Regenerative medicine experts call on UK MHRA to press for EU-wide regulatory changes (SCRIP RA-$)
  • Human factors engineering initiative likely to result in guidance, says UK expert (Clinica-$)
  • GMP for excipients: new EU rules on raw materials, packaging, tracking (In-Pharma)
  • MHRA assists development of UK manufacturing site for innovative drug-device product (MHRA) (MHRA)
  • EC Approves Cubist's Sivextro (Press)
  • WHO: Medicine costs ‘too high’ for European governments (PMLive) (Pharmafile) (Reuters)
  • Drugs companies unite to mine genetic data (CNBC)
  • French unveil plan to save €350m through greater use of generics (SCRIP-$)
  • Regulus' RG-012 receives orphan medicinal product designation in EU for treatment of Alport syndrome (Press)
  • Santen Announces Approval of Ikervis for EU Marketing Authorisation (Press)

India

  • Pharmacy Students Should be Trained in Regulatory Affairs, Says Head of Pharma Group (PharmaBiz)
  • First world's discarded medical devices flood Indian markets (India Times)

Japan

  • Japan's MHLW approves Gilead's Sovaldi for genotype 2 chronic hep C (Fierce)
  • Actelion says wins Japanese approval for heart and lung drug (Reuters)
  • Takeda's once-weekly DPP-4 inhibitor cleared in first market (PMLive)
  • Eisai Obtains Japanese Approval for Thyroid Cancer Drug Lenavima (Press)
  • GSK receives approval for Encruse Ellipta in Japan for the treatment of COPD (Press)
  • Getting pharma policy and regulation right the Japanese way (SCRIP RA-$)

Canada

  • Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall) (Health Canada)
  • Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment (Health Canada)

Australia

  • Australia Clarifies Postmarket Reviews of Subsidized Drugs (FDAnews-$)

Other International

  • Towards a Unified Sampling Terminology: Clarifying Misperceptions (PubMed)
  • AHWP's New Playbook on Harmonizing Medical Device Regulations (AHWP)
  • GHTC Releases 2015 Policy Report on Global Health Priorities (GHTC)

Clinical Trials

  • Janssen regulatory director on CROs: “They’ll screw you in a heartbeat” (MedCityNews)
  • Parexel audit reports come under scrutiny thanks to Ranbaxy’s FDA lawsuit (Outsourcing Pharma)
  • Reporting Bias in Clinical Trials Investigating the Efficacy of Second-Generation Antidepressants in the Treatment of Anxiety Disorders: A Report of 2 Meta-analyses (PubMed)

General Regulatory And Interesting Articles

  • In Iceland’s DNA, New Clues to Disease-Causing Genes (NYTimes) (MIT TR) (Forbes)
  • Researchers develop test that predicts severe immune reaction to biologics (Pharm-Journal)
  • Nootropics and the Human Lab Rats of Reddit (Gizmodo)
  • 5 Drugs that You Won’t Believe Come as Suppositories (iodine)
  • Antibiotics Pipeline Boasts 741 Products, but First-in-class Development Remains Low (Press)
  • Safer Anthrax Test Aims To Keep The Bioweapon From Terrorists (NPR)
  • Study links use of macrolide antibiotics in pregnancy to infant epilepsy and cerebral palsy (PharmJournal)

Regulatory Reconnaissance #522 – 26 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.


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