Regulatory Focus™ > News Articles > Regulatory Recon: Orphan Drugs See Record Number of Approvals in EU (9 January 2015)

Regulatory Recon: Orphan Drugs See Record Number of Approvals in EU (9 January 2015)

Posted 09 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Orphan Drugs See Record Number of Approvals in EU (9 January 2015)

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

In Focus: US

  • FDA approves anti-clotting drug Savaysa (FDA) (Reuters) (SCRIP-$) (Forbes) (Pharma Times) (Press)
  • REMS That Block Generics Are ‘Major’ Problem For FDA, Jenkins Says (Pink Sheet-$)
  • Why has FDA Issued so few Warning Letters About Drug Marketing? (Pharmalot)
  • Pfizer's New Type of Cancer Drug May Get Early OK (AP) (Reuters) (SCRIP-$)
  • Roche says U.S. regulators approve blood test for three viruses (Reuters) (Press)
  • Diagnostics Group: Regulatory Changes Threaten Patient Access to Innovations in Genomic Medicine (AMP)

In Focus: International

  • EU: Record number of medicines for rare diseases recommended for approval in 2014 (EMA)
  • China to allow online sales of prescription drugs as early as this month: sources (Reuters)
  • EU reveals proposals on pharma in TTIP talks (SCRIP-$)
  • BMS' Opdivo set for early access in UK (PMLive)
  • India: Violators under new Drug and Cosmetics Bill may get 5-year jail (India Times)
  • India: Drug manufacturing industry cries foul over poor regulation (India Times)

US: Pharmaceuticals and Biotechnology

  • FDA approves anti-clotting drug Savaysa (FDA) (Reuters) (SCRIP-$) (Forbes) (Pharma Times) (Press)
  • REMS That Block Generics Are ‘Major’ Problem For FDA, Jenkins Says (Pink Sheet-$)
  • Why has FDA Issued so few Warning Letters About Drug Marketing? (Pharmalot)
  • Pfizer's New Type of Cancer Drug May Get Early OK (AP) (Reuters) (SCRIP-$)
  • Hospira recalls another product made at Australian plant cited by FDA (Fierce) (In-Pharma)
  • 5 Lessons From FDA's First Biosimilar Review (Law 360-$)
  • BIO Head: FDA Needs to Release More Biosimilars Guidance (BIO)
  • Should FDA Change Metformin's Black Box Warning? (MedPage Today)
  • FDA Posts Advisory Committee Materials for Ferring’s NOCDURNA for Nocturnal Polyuria (Tarius) (Pink Sheet-$)
  • Zydus site clears data integrity hurdle in FDA audit? (SCRIP-$)
  • Gilead Wins Dismissal Of Defective Drug Fraud Suit (Law 360-$)
  • Judge Urged to Kill AstraZeneca, Ranbaxy Pay-For-Delay Deal (Law 360-$)

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

  • Ph III trial for AbbVie’s elagolix meets endpoints (PharmaLetter-$) (MM&M)
  • Sanofi and Regeneron post positive alirocumab results (Pharmafile) (Reuters)
  • Neurocrine jumps on Phase III endometriosis data (BioCentury)
  • Karyopharm's selinexor gets FDA orphan drug status to treat multiple myeloma (PBR)
  • Retrophin Granted Orphan Drug Designation for Sparsentan (Press)

US: Pharmaceuticals and Biotechnology: General

  • Sens. Float Bill To Let Medicare Negotiate Drug Prices (Law 360-$)

US: Medical Devices

  • Roche says U.S. regulators approve blood test for three viruses (Reuters) (Press)
  • Diagnostics Group: Regulatory Changes Threaten Patient Access to Innovations in Genomic Medicine (AMP)
  • BBS Revolution Automatic Bladder Volume Measurement Device FDA Cleared (MedGadget)
  • C.R. Bard pushes for delay of vaginal mesh trial after judge's call for settlement (Fierce) (Mass Device)
  • FDA lifts import ban on Hospira infusion pumps (Mass Device) (Gray Sheet-$)
  • HGI Industries Announces FDA Approval of the Odorox MDU/Rx Device for Use in Medical Facilities (Press)
  • PorOsteon Announces FDA Clearance of the Phusion Metal Cervical Cage (Press)

US: Dietary Supplements

  • FTC Sues Children's Supplement Maker For False Claims (Law 360-$)
  • Walgreen Escapes False Ad Suit Over Homeopathic Ear Meds (Law 360-$)
  • FDA warning over infant's death shouldn't call safety of probiotics into question, experts say (NI-USA)
  • Enforcement of FDA qualified health claims: Who’s on the case? (Inside Counsel)

Upcoming Meetings

Ebola Outbreak

  • Pivotal Ebola vaccine trials to start this month or next: WHO (Reuters) (Bloomberg)

Europe

  • Record number of medicines for rare diseases recommended for approval in 2014 (EMA)
  • EU reveals proposals on pharma in TTIP talks (SCRIP-$)
  • BMS' Opdivo set for early access in UK (PMLive)
  • Covidien’s Stellarex Drug-Coated Angioplasty Balloon Receives CE Mark to Treat Peripheral Arterial Disease Patients (Press)
  • Germany gives green light to Viiv's Triumeq for HIV (PMLive)
  • Illicit vendors using YouTube to advertise fake drugs, says MHRA (In-Pharma)

India

  • Violators under new Drug and Cosmetics Bill may get 5-year jail (India Times)
  • Drug manufacturing industry cries foul over poor regulation (India Times)
  • Indian pharma’s lack of investigations & appropriate lab systems lead to poor quality metrics standards: AG Raghu (PharmaBiz)

China

  • China to allow online sales of prescription drugs as early as this month: sources (Reuters)
  • US FDA lens on China bad news for Indian drug makers (Business Standard)

Japan

  • How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach (TIRS)
  • Japan to be hot destination for trials in 2015 say experts, despite drop in MRCTs last year (Outsourcing Pharma)

Clinical Trials

  • Effective Drug Supply for Adaptive Clinical Trials (TIRS)
  • Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products (TIRS)
  • Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes (TIRS)
  • The Patient-Reported Outcome (PRO) Consortium: Lessons Learned Along the Path to PRO Instrument Qualification (TIRS)
  • Incorporating Historical Data in Bayesian Phase I Trial Design: The Caucasian-to-Asian Toxicity Tolerability Problem (TIRS)

General Regulatory And Interesting Articles

  • A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward? (TIRS)
  • The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline Development (TIRS)
  • Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases (TIRS)

Regulatory Reconnaissance #468 – 9 January 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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