Regulatory Focus™ > News Articles > Regulatory Recon: The Last Two Weeks in Brief (5 January 2015)

Regulatory Recon: The Last Two Weeks in Brief (5 January 2015)

Posted 05 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: The Last Two Weeks in Brief (5 January 2015)

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

In Focus: US

  • Biopharma posts a chart-topping 41 new drug approvals in 2014 (Fierce) (AP) (Forbes) (Reuters)
  • First Biosimilar Gets FDA Staff Nod as Amgen Drug Draws Imitator (Bloomberg) (Reuters)
  • FDA approves Sovaldi/Harvoni Competitor Viekira Pak to treat hepatitis C (FDA) (Fierce)
  • FDA Delays Track and Trace Requirements Until May 2015 (FDA) (Porzio) (FDA Law Blog) (TraceLink) (RxTrace)
  • FDA Plans To Ease Ban on Gay Men Donating Blood (AP) (CNBC) (FDA)
  • FDA Clarifies its Position on Orphan Drug Exclusivity After Depomed Court Decision (FDA) (FDA Law Blog)
  • New Draft Guidances on Minimal Manipulation (FDA) (FDA) (FDA) (Guidance) (Guidance)
  • FDA Guidance On Health Care Economic Data Is Coming In 2015 (Pink Sheet-$)
  • FDA begins shift to full-scale Sentinel system (BioCentury) (FDA)
  • New Draft Guidance on Transfering Ownership of 510(k) Applications (FDA) (FDALawBlog) (Guidance)
  • CLIA Waiver Wave? Applications Up In FY 2014 After A Prior-Year Lull (Gray Sheet-$)
  • Study: Some hypertension apps are making misleading claims (mHealthNews) (Reuters)
  • Roche wins FDA approval for emergency use of rapid Ebola test (Fierce)
  • FDA outlines UDI implementation plans for 2015 (Fierce)

In Focus: International

  • EMA Hiring New Executive Director—Could it be Rasi? (EMA)
  • EU drug approvals soared in 2014 (PharmaTimes) (PMLive)
  • EMA ramps up adaptive pathways pilot (Pharmafile) (EMA)
  • EMA Releases Strategy to Combat Fraud, Bias in Product Reviews (FDAnews-$)
  • EMA 2015 budget up, applications set to rise (SCRIP-$) (EMA)
  • Transparency and the European Medicines Agency — Sharing of Clinical Trial Data (NEJM)
  • Thalidomide Victims In Spain Still Waiting For Compensation (NPR)
  • More on EU medical devices cybersecurity regulation (MedDeviceLegal)
  • Indian Industry Vows To Tackle Pharma Quality Woes (Pink Sheet-$)
  • Trial Waivers May Trigger Early Indian Launch Of Sofosbuvir Copies (PharmAsia-$)
  • Patent Office revokes the patent of Roche's osteoporosis drug Bonviva (Business Standard)
  • Apex committee on clinical trials grants approval to 28 proposals (PharmaBiz)
  • India notifies tweaked trial compensation rules (SCRIP-$)
  • China promises faster drug approvals, equal treatment for U.S. companies (Fierce) (AP)
  • China Agrees To Streamline Imports Of U.S. Medical Devices (MDO) (Fierce) (Fierce)
  • ICH and USP Agree to Harmonize Metal Impurity Limits (Gold Sheet-$)

US: Pharmaceuticals and Biotechnology

  • Biopharma posts a chart-topping 41 new drug approvals in 2014 (Fierce) (AP) (Forbes) (Reuters)
  • First Biosimilar Gets FDA Staff Nod as Amgen Drug Draws Imitator (Bloomberg) (Reuters)
  • FDA approves Sovaldi/Harvoni Competitor Viekira Pak to treat hepatitis C (FDA) (Fierce)
  • FDA Delays Track and Trace Requirements Until May 2015 (FDA) (Porzio) (FDA Law Blog) (TraceLink) (RxTrace)
  • FDA Plans To Ease Ban on Gay Men Donating Blood (AP) (CNBC) (FDA)
  • FDA Clarifies its Position on Orphan Drug Exclusivity After Depomed Court Decision (FDA) (FDA Law Blog)
  • New Draft Guidances on Minimal Manipulation (FDA) (FDA) (FDA) (Guidance) (Guidance)
  • FDA Guidance On Health Care Economic Data Is Coming In 2015 (Pink Sheet-$)
  • FDA begins shift to full-scale Sentinel system (BioCentury) (FDA)
  • Biologics Exclusivity: GPhA Making Last Stand In Pacific (Pink Sheet-$)
  • OPDP slams print ad in Untitled Letter (MM&M)
  • FDA Hiring a Director of its Office of Pharmaceutical Quality (FDA)
  • 2014 a Record Year for FDA: Fewest Number of Untitled Letters Ever (Pharma Marketing Blog)
  • Dunn permanent successor to Katz at FDA neurology division (BioCentury-$)
  • Drug Reviewer’s Emails to Regulator Prompt Warning Letter to Aegerion (WSJ-$)
  • PDUFA VI Predictions: Industry Might Pay More, Get More From User Fees (Pink Sheet-$)
  • The Slippery Slope: A Bittersweet Diabetes Economy (MedPage Today)
  • 5 Takeaways from the Diabetes Drugs Investigation (Medpage Today)
  • Celebrex Generic Exclusivity Suit Could Have Broad Financial, Regulatory Reach (Pink Sheet-$) (Pink Sheet-$)
  • Incoming Mass. AG may sue drug cos. to rein in Rx abuse (Boston Herald)
  • Chinese API Manufacturer Is Latest to Receive Warning for Data Integrity as Scrutiny Intensifies (FDAnews-$) (Letter)
  • A Closer Look At Web Portals for DSCSA Transaction Data Exchange (RxTrace)
  • Lilly's Elanco disputes local paper's allegations of unsafe pet meds (Fierce)
  • New Jersey District Court Issues First Written Opinion in REMS Antitrust Litigation Involving ANDA Biostudy Sample Procurement (FDA Law Blog)
  • FDA trusts vets to curb antibiotic use, but are ties to drug companies too tight? (Fierce)
  • The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges (PubMed)
  • FDA Rejecting Fewer Proprietary Names (RPM Report-$)
  • Lifting the ‘Breakthrough’ Veil: FDA Increases Transparency To Reduce Futile Requests (Pink Sheet-$)
  • Evergreening Gets Trimmed? Product Switching Suits On Namenda, Others Proceeding (Pink Sheet-$)
  • Novo Nordisk kick-starts its obesity franchise with a long-awaited FDA nod (Fierce)
  • Bristol-Myers' pioneering PD-1 drug Opdivo OK'd by FDA for melanoma (Fierce) (FDA)
  • AstraZeneca grabs a surprise early approval for its $2B cancer contender Olaparib (Fierce) (FDA)
  • Cubist scores another FDA nod, this time for Tazobactam (Fierce) (FDA)
  • FDA approves weight-management drug Saxenda (FDA)
  • Galderma Receives FDA Approval for Rosacea Treatment (PharmPro)
  • Actavis and Adamas Announce FDA Approval of Namzaric for Alzheimer’s Disease (PharmPro)
  • FDA Approves New Kaleydeco NDA for Cystic Fibrosis (Press)
  • Hospira's non-opioid painkiller gets FDA approval (Reuters)
  • FDA approves Bayer’s Gadavist (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age (Press)
  • FDA Approves BioCryst's Oral Flu Drug Rapivab (AP) (FDA)
  • Flu Strain Selection Meeting Announced (FDA)
  • Jazz Pharmaceuticals Receives FDA Approval for Intravenous Administration of Erwinaze (Press)
  • FDA Advises Starting With the Lab When Sniffing Out Data Integrity (Gold Sheet-$)
  • Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations (FDA)
  • Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance (FDA)
  • Wockhardt, Cadila and Hospira voluntarily recall drugs in US (India Times)
  • Hospira Recalls Ten Lots of Mitoxantrone (Press)
  • Actavis goes 1-for-2 with FDA as regulators knock blood pressure combo (Fierce)
  • Home Confinement Ordered for Ex-Pharmacy Officials (AP)
  • Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study (PubMed)
  • Drug unapproved by FDA saves infant's life (CBS)
  • Fresenius closes out recall started two years ago (Fierce)

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

  • Baxter Submits Application for U.S. FDA Approval of BAX111, Investigational Recombinant Treatment for Von Willebrand Disease (Press)
  • Endo NDA Submitted for Buprenorphine Buccal Film for Pain (MPR)
  • Spectrum Submits NDA for Propylene Glycol-Free Melphalan (MPR)
  • Roche's bid to sub Kadcyla for Herceptin takes a big hit with lackluster PhIII data (Fierce)
  • Jaguar Animal Health Initiates Filing of Its First New Animal Drug Application With FDA (Press)
  • Alexion Completes Rolling Submission Of BLA For Asfotase Alfa (RTT)
  • Safinamide NDA Resubmitted for Parkinson's Disease (MPR)
  • Taiho Completes Rolling NDA For TAS-102 In mCRC (PharmAsia-$)
  • PTC Therapeutics Begins Rolling NDA Submission To FDA For Translarna (RTT)
  • Actelion submits US FDA New Drug Application for selexipag (Uptravi) in patients with pulmonary arterial hypertension (Press)
  • NeuroDerm shares double as Parkinson's drug shows promise (Reuters)
  • Spectrum submits new drug application to FDA for CE-Melphalan (PBR)
  • Relypsa Announces Assignment of October 21, 2015 PDUFA Date for New Drug Application for Patiromer for Oral Suspension (Press)
  • Cempra's lead oral antibiotic meets main goal in late-stage trial (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Metformin: A Great Lakes Disaster? (MedPage Today)
  • FTC Issues First Post-Actavis Staff Report on Drug Patent Settlement Agreements; No Meaningful Conclusions on the Effects of Actavis Decision Can Yet Be Drawn (FDA Law Blog)

US: Medical Devices

  • New Draft Guidance on Transfering Ownership of 510(k) Applications (FDA) (FDALawBlog) (Guidance)
  • CLIA Waiver Wave? Applications Up In FY 2014 After A Prior-Year Lull (Gray Sheet-$)
  • Study: Some hypertension apps are making misleading claims (mHealthNews) (Reuters)
  • Roche wins FDA approval for emergency use of rapid Ebola test (Fierce)
  • FDA approves pathogen reduction system to treat platelets (FDA)
  • FDA OKs Emergency Authorization of Ebola Test (AP) (FDA)
  • FDA Approves Aethlon Medical's Ebola Treatment Protocol (PharmPro)
  • FDA Hiring Director of Medical Device Programs (FDA)
  • FDA outlines UDI implementation plans for 2015 (Fierce)
  • Senators Support Adding Device ID to Claims (Pew) (Gray Sheet-$) (Fierce)
  • Cybersecurity Center Invites Feedback on Securing Medical Devices (Fierce)
  • Round-up: 31 FDA clearances for digital health in 2014 (MobiHealthNews)
  • Independent Assessment of the Process for the Review of Device Submissions; Final Implementation Plan (FDA)
  • Radiation Biodosimetry Devices; Draft Guidance (FDA) (Guidance)
  • Next Generation Sequencing Diagnostic Tests; Public Workshop (FDA)
  • General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • FDA approves Medtronic's In.Pact Admiral balloon (MassDevice)
  • Myriad scores FDA approval for ovarian cancer companion Dx (Fierce)
  • FDA Finds Gaps In Cesca's Stem Cell Trial Plan For Critical Limb Ischemia (Gray Sheet-$)
  • Positive study for Smith & Nephew's Pico wound therapy (Mass Device)
  • Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel Device (Press)
  • Medtronic Drug-Coated Balloon for Peripheral Artery Disease Tops Standard Balloon Angioplasty in Landmark Study (Medtronic) (Fierce)
  • Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices (GxP Lifeline)
  • Quidel Receives Simultaneous FDA Clearance And CLIA Waiver For Its Sofia Strep A+ Fluorescent Immunoassay (FIA) Via The FDA's New Dual Submission Program (Press)
  • LifeWatch gets FDA clearance for adhesive, remote patient monitoring wearable (mobiHealthNews)
  • Olympus Narrow Band Imaging for Cystoscopy Cleared by FDA (MedGadget)
  • Nightly Home Hemodialysis Gains First FDA Clearance (Gray Sheet-$) (MDO)
  • Roxwood Medical announces FDA 510(k) clearance andUS commercial launch of its CenterCross Catheter (MNT)
  • Sorin says newly cleared Memo 3D ReChord will improve mitral valve repair (Fierce)
  • EOS imaging obtains FDA approval for hipEOS, the first 3D stereoradiographic planning software for hip arthroplasty (MNT)
  • HEPATIQ Receives FDA Clearance (Press)
  • App to Diagnose Head Injuries Scores FDA Clearance (PDD)
  • 510(k) long-term hemodialysis catheter (Press)
  • Bio2 Technologies wins FDA nod for bioactive bone scaffolds (Mass Device)
  • Philips redesign prompts another Class I recall (Mass Device)

US: Dietary Supplements

  • FDA Targeting Sellers of Pure Caffeine Powder (AP) (CBS)
  • Consent Decree ‘Unnecessary’ But Still Scilabs Nutraceuticals’ High Road For GMP Compliance (Tan Sheet-$)
  • NPA Supports Open Petition Process for ID Testing Exemption (NPI)

US: Assorted And Government

  • FDA's Strategic Priorities: 2014 – 2018 (Policy and Medicine)
  • Upcoming FDA Science Board Meeting (FDA)
  • Special 301 Review Meetings Scheduled (FR)
  • FDA/CMS Summit Demonstrates Increasing Importance for Parallel Review Considerations and Ongoing FDA and CMS Reform (FDA Life) (2)
  • OIG Posts 2015 Work Plan, Including Oversight of FDA (OIG)
  • Enforcement Report - Week of December 24, 2014 (FDA)

Upcoming Meetings

Ebola Outbreak

  • Roche wins FDA approval for emergency use of rapid Ebola test (Fierce)
  • FDA OKs Emergency Authorization of Ebola Test (AP) (FDA)
  • FDA Approves Aethlon Medical's Ebola Treatment Protocol (PharmPro)
  • Are Placebos Ethical In Ebola Trials? (Forbes)
  • Untested Ebola drug given to patients in Sierra Leone causes UK walkout (Guardian)
  • Tekmira to supply Ebola treatment for studies in West Africa (Reuters)
  • BioCryst's Ebola drug shows promise in animal study (Reuters)
  • Merck-NewLink Ebola vaccine trial resumes at lower dose: Geneva hospital (Reuters)

Europe

  • EMA Hiring New Executive Director—Could it be Rasi? (EMA)
  • EU drug approvals soared in 2014 (PharmaTimes) (PMLive)
  • EMA ramps up adaptive pathways pilot (Pharmafile) (EMA)
  • EMA Releases Strategy to Combat Fraud, Bias in Product Reviews (FDAnews-$)
  • EMA 2015 budget up, applications set to rise (SCRIP-$)
  • EMA work programme 2015-2016 (EMA)
  • Transparency and the European Medicines Agency — Sharing of Clinical Trial Data (NEJM)
  • Mitigating risks due to the use of antibiotics in animals (EMA)
  • Simplification of submission of product information updates in periodic safety update reports for nationally authorised products (EMA)
  • Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) /limited market (EMA)
  • New vaccine against Bovine Viral Diarrhea: Boehringer Ingelheim receives European marketing authorization for Bovela (Press)
  • EU court ruling removes another obstacle to stem cell patenting (Clinica-$)
  • More on EU medical devices cybersecurity regulation (MedDeviceLegal)
  • Thalidomide Victims In Spain Still Waiting For Compensation (NPR)
  • Mistakes made by patients using medical devices points to need for better training (PharmJournal-$)
  • Assessing drugs for ultra-rare conditions in the UK (PMLive)
  • CHMP Positive On Safinamide, First New Parkinson’s Therapy In 10 Years (Pink Sheet-$)
  • Orexigen's weight-loss drug gets thumbs-up from CHMP (Fierce)
  • Crohn's patients unlikely to get NHS access to Entyvio (PharmaTimes)
  • Chiesi gets first-ever European stem cell nod (Pharmafile)
  • Italian Medicines Agency lifts Fluad suspension following tests on batches under question (PharmaLetter-$)
  • Lilly to market stomach cancer drug in Europe (Pharmafile)
  • EU allows use of Novartis eye drug in children (PharmaTimes)
  • NICE reviews five ovarian cancer drugs (PharmaTimes) (PMLive)
  • Actelion submits new PAH drug in EU (PharmaTimes)

India

  • Indian Industry Vows To Tackle Pharma Quality Woes (Pink Sheet-$)
  • Last Week in India (Two-Four Insight) (2)
  • Trial Waivers May Trigger Early Indian Launch Of Sofosbuvir Copies (PharmAsia-$)
  • The Government Of India’s 2015 Commitments (Two-Four Insight)
  • Centre for drug price watchdogs in states (India Times)
  • Patent Office revokes the patent of Roche's osteoporosis drug Bonviva (Business Standard)
  • India warns Egyptian companies claiming to have Sovaldi for sale (Fierce)
  • Apex committee on clinical trials grants approval to 28 proposals (PharmaBiz)
  • India notifies tweaked trial compensation rules (SCRIP-$)
  • AIDCOC wants Centre to focus on increasing adequate manpower within the regulatory agency (PharmaBiz)
  • Senior staff crunch cripples functioning of Tamil Nadu Drug Control Admn (PharmaBiz)
  • 80 per cent drop in new drug launches as price control list expands (India Times)
  • Health ministry constitutes committee for examining and recommending amendments in D&C Rules (PharmaBiz)
  • IPC ties-up with WHO for training healthcare experts under national health programmes on ADR reporting (PharmaBiz)
  • Drug stockists admit short supply of many vital drugs in retail stores post NPPA price cut (PharmaBiz)

China

  • China promises faster drug approvals, equal treatment for U.S. companies (Fierce) (AP)
  • China Agrees To Streamline Imports Of U.S. Medical Devices (MDO) (Fierce) (Fierce)
  • Taiwan, China embark on cross-strait clinical studies (BioCentury)
  • Drug price changes loom in China (BioCentury)

Japan

  • Latest Japan Approvals Include World Firsts (PharmAsia-$)
  • BioMarin's Vimizim OK'd in Japan for Morquio A (SCRIP-$)
  • Novartis Psoriasis Drug Approved in Japan (WSJ-$)
  • Takeda/Otsuka's new PPI secures Japanese approval (SCRIP-$)
  • Eisai Receives Approval For Indication Expansion Of Proton Pump Inhibitor Pariet® For Use In Prevention Of Recurrent Gastric Or Duodenal Ulcer Caused By Low-Dose Aspirin Therapy And Additional 5 Mg Tablet Formulation In Japan (Press)

Canada

  • Health Canada Quarantines Products From Two Indian Companies (PharmPro)
  • Health Canada Opens Consultation on Tamper-Resistant Opioids (HC)
  • Opinion: Health Canada fails to enforce its own rules on pharmaceutical advertising (Montreal Gazette)
  • Health Canada Opens Consultation on Product Monographs (HC)

Australia

  • Australia to ban sunbeds to reduce skin cancer cases (BioSpectrum)
  • Australia Warns about St. Jude Implantable Devices, Citing Software Risks (TGA)

Other International

  • Fifty-four New Drugs and Biologics Make their Debut in 2014 (Thompson Reuters)
  • ICH and USP Agree to Harmonize Metal Impurity Limits (Gold Sheet-$)
  • Pharmaceutical Industry Reports Progress in ICH Q10 Implementation (Gold Sheet-$)
  • IMDRF Posts New Procedural Documents (IMDRF)
  • APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes (IPQ-$)
  • Philipines FDA warns about medicines stolen from Abbott Laboratories (TV5)
  • Brazilian pharma industry sues regulator (SCRIP-$)

Clinical Trials

  • The Proposed Rule for U.S. Clinical Trial Registration and Results Submission (NEJM)

General Regulatory And Interesting Articles

  • Incorporating patient-preference evidence into regulatory decision making (PubMed)
  • Device Squeezes Cells to Get Drugs In (MIT TR)
  • Researchers Create Artificial Organs On Microchips (NPR)
  • U.S. cancer deaths fell 22 percent since 1991 (Reuters)

Regulatory Reconnaissance #464 – 5 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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