Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 June 2013)

Regulatory Reconnaissance (3 June 2013)

Posted 03 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • How KV Pharmaceuticals' Pricey Pregnancy Medicine Makena Made a Comeback (WSJ)
  • Pressure Grows to Create, Approve Drugs for 'Superbugs' (NYTimes)
  • FDA Oncology Chief Pazdur Vows to Accelerate 'Breakthrough' Drug R&D (Fierce)
  • Infections Linked to Tainted Compunded Steroids (Med Page Today) (Space Coast Daily) (SCRIP Intelligence)
  • The FDA's Dilemma About Ibuprofen And Cardiovascular Risk (Forbes)
  • UChek's Bizarre Response to an FDA Letter: An Unfolding Saga (MDDI)
  • Good Acceptance Records Can Save The Day When FDA Comes Calling (FDA News)
  • Punytive Damages: Are Fines for Noncompliance too Small to Make a Statement? (IIB)
  • Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives "Resounding Yes" (The Pink Sheet)
  • FDA 2014 Budget Primer (FDA Alliance)
  • Our Roundup of the Top ASCO News

In Focus: International

  • Will Hepatitis C Become The Next Battleground Over Compulsory Licenses? (Pharmalot)
  • Compromise Sought On Device Reform Proposal In European Parliament Committee (Gray Sheet) (Clinica)
  • Viagra Patent Expires in UK in Less Than a Month (Telegraph)
  • EU Updates Several Electronic Application Forms (eSubmission)
  • European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma (EMA) (The Pink Sheet) (Fierce) (SCRIP Intelligence)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Looks to Reconsider Restrictions on Diabetes Drug (NYTimes)
  • Pressure Grows to Create, Approve Drugs for 'Superbugs' (NYTimes)
  • FDA oncology chief Pazdur vows to accelerate 'breakthrough' drug R&D (Fierce)
  • FDA Inspections Taking a Toll On Compounders (Pain Medicine News)
  • FDA Issues Complete Response Letter on SEFELSA™ New Drug Application (Boardvote)
  • Sen. Schumer Asks FDA To Approve More Effective Sunscreens (NY1)
  • Infections Linked to Tainted Compunded Steroids (Med Page Today) (Space Coast Daily) (SCRIP Intelligence)
  • FDA Approves ANDAs for Banner Pharmacaps' Dutasteride, Anchen's Clonidine Hydrochloride (FDA)
  • Cancer Drug Shortages Force Doctors to Ration, Delay Treatment (Bloomberg)
  • Oxford BioMedica pauses some trials after finding potential impurities (Reuters)
  • FDA Warning Says 483 Response Lacks 'Holistic' Action Plan (FDA News)
  • How KV Pharmaceuticals' Pricey Pregnancy Medicine Makena Made a Comeback (WSJ)
  • FDA: Allergy Meds Could Affect Your Driving (FDA)
  • Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies (Harvard Bill of Health)
  • The FDA's Dilemma About Ibuprofen And Cardiovascular Risk (Forbes)
  • GSK Set To File Votrient For Ovarian Cancer On Strong PFS (The Pink Sheet)
  • Antibiotics overused, study says (CBS)
  • Sarepta's meeting with FDA now expected later than first hoped (Boston Biz Journal)
  • Avanir Sues Sandoz Over Nuedexta Generic (Law 360)
  • The Federal Lot-Based Pedigree Before Congress (RxTrace)
  • State, Federal NECC Tort Cases To Join Meningitis MDL (Law 360)
  • FDA subcommittee to examine regulatory science for neonatal studies (Contemporary Pediatrics)
  • The U.S. prescription drug market is dominated by generics. Is that a good thing? (MPT)
  • FDA, Merck Clash Over Value Of Subjective Insomnia Endpoints (The Pink Sheet)
  • FDA Says it Has Resolved Shortage of Propofol (FDA)
  • FDA to patients: Do not stop taking your angiotensin receptor blocker blood pressure medication without talking to a healthcare professional (FDA)
  • GSK's Tykerb/Tyverb Combo for HER2-Postive Breast Cancer Fails PhIII Trial (GSK)
  • Cancer drug shortages hit 83 percent of US oncologists (EurekAlert)
  • NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014: Proposed Additions and Deletions to the NIOSH Hazardous Drug List (CDC)
ASCO In Brief
  • Glaxo drug shown to delay ovarian cancer relapse (Reuters) (NYTimes) (GSK)
  • Pfizer Drug Delays Worsening of Lung Cancer vs. Chemotherapy (WSJ)
  • Roche's Avastin extends life in advanced cervical cancer (Reuters) (Roche) (The Pink Sheet)
  • Roche's Avastin Fails to Prolong Survival of Brain Cancer Patients (The Street) (Roche) (NYTimes)
  • Amgen melanoma drug improved survival by 21 percent in interim look (Reuters) (Fierce) (The Street) (SCRIP)
  • Bristol drug shrinks melanoma in 31 percent of trial patients (Reuters) (BMS) (Fierce) (The Street)
  • REMS Education Paradox: How Can Sponsors Create Independent CME? (The Pink Sheet)
  • "Complete Response" Letters Might Include Benefit-Risk Framework Discussion (The Pink Sheet)
  • Drug is a first to help patients with melanoma of the eye (Reuters) (Fierce)
  • Longer tamoxifen use reduces breast cancer recurrence (Reuters)
  • Combo immunotherapies reduce risk of death for melanoma patients (Fierce)
  • Merck melanoma drug shrinks tumors in 38 percent of patients (Reuters) (Fierce)
  • Merck KGaA's Erbitux beats Avastin in bowel cancer trial (Reuters)
  • Boehringer Ingelheim: Superiority of afatinib* over comparator chemotherapy for patients with EGFR mutation-positive advanced lung cancer is reinforced by second Phase III study (BI)
  • Merck Announces Presentation of Interim Data from Study Evaluating Lambrolizumab, an Investigational Anti-PD-1 Antibody, in Patients with Advanced Melanoma at ASCO 2013 (Merck)
  • Eisai Presents New QOL Findings in Patients with Metastatic Breast Cancer from Halaven (Eribulin) vs Capexitabine Study (Eisai)
  • Onyx's Nexavar Delays Growth of Thyroid Cancer (The Street) (Fierce)(SCRIP)
  • Array Drug First to be Effective Against Melanoma of the Eye (The Street)
  • Five Promising Cancer Drug Results (Forbes)
  • Highlights from ASCO: Bayer's Nexavar; Novartis' Afinitor; and Amgen's talimogene laherparepvec (The Pharma Letter)
  • Merck, Roche, BMS impress at ASCO, but questions linger (SCRIP)
Medical Devices
  • UChek's Bizarre Response to an FDA Letter: An Unfolding Saga (MDDI)
  • Good Acceptance Records Can Save The Day When FDA Comes Calling (FDA News)
  • FDA Puts Strengthened Emergency Authority To Use For Diagnostics (The Gray Sheet)
  • The smallest device ever approved by FDA (Beaker)
  • Boston Scientific Unit Can't Duck FCA Claims, DQ Blank Rome (Law 360)
  • Cochlear Americas Receives FDA Approval for the First and Only Ear Level Accessory for Waterproof Hearing with Cochlear Implants (FDA)
  • Longer reach guide catheter nets 510(k) status (Cardiovascular Business)
  • GE Healthcare Announces 510(k) Clearance of New Brivo Plus C-arm for the US (GE)
  • Prospective Grant of Co-Exclusive Licenses: Multi-Focal Structured Illumination Microscopy Systems and Methods (NIH)
  • Sensus SRT-100 Now FDA Approved for Keloids (MedGadget)
Assorted and Government
  • FDA 2014 Budget Primer (FDA Alliance)
  • Punytive Damages: Are Fines for Noncompliance too Small to Make a Statement? (IIB)
  • What FDA Authorizers and Appropriators Are Doing - The Disconnect (Strengthen FDA)
  • Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives "Resounding Yes" (The Pink Sheet)
  • The Endless Clinical Trial of Stanislaw Burzynski (BBC)
  • Flying blind: the impacts of sequesters (Federal Times)
  • Deeper budget cuts are threatened in 2014 (Federal Times)
  • Weighing in on Dietary Supplement Weight-Loss Claims (Natural Products Insider)
  • Slower health spending, Obamacare add 2 years to Medicare's life (SCRIP Intelligence)
  • US Capitol Capsule: Allies offer Alzheimer's advice: Combo attack (SCRIP Intelligence)
Upcoming Meetings and Events
  • 3 June 3013: House Energy and Commerce Committee to Vote on Track and Trace, ADUFA/AGDUFA Bills Bill (E&C) (The Hill)
  • 5-6 June 2013: Two-Day Avandia Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • EMA updating guidance on pain products (BioCentury)
  • EU regulators to fine Lundbeck, Merck, seven other drug firms - sources (Reuters)
  • Will Hepatitis C Become The Next Battleground Over Compulsory Licenses? (Pharmalot)
  • UK Bribery Act: Reducing the Red Tape (GRELB)
  • Compromise Sought On Device Reform Proposal In European Parliament Committee (Gray Sheet)
  • India: Fall in clinical trials & poor pipeline of blockbuster drugs impact access to newer medicines to treat tobacco related cancers: Experts (PharmaBiz)
  • India Releases New Organ and Tissue Transplant Rules (MHFW)
  • Viagra Patent Expires in UK in Less Than a Month (Telegraph)
  • EU Updates Several Electronic Application Forms (eSubmission)
  • Little Support for U.S.-Style Approval Seen in EU Device Regulation Debate (FDA News)
  • Party Like Your Drug's Going Generic: Wyeth's Epic Party (The Globe and Mail)
  • Consultation: TGA guidance on release for supply for medicines manufacturers (TGA)
  • EU Launches New Translational Science Institute, EATRIS (EU)
  • Novartis case means China expediting early trials? (SCRIP)
  • Updates to the former Australian Regulatory Guidelines for Prescription Medicines (TGA)
  • EU withdraws Servier's almitrine (SCRIP Intelligence)
  • Teva's Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN) (Business Wire)
  • Japanese Ministry Panel Split On Lifting Ban On Internet Sales Of Class I Drugs (PharmAsia News)
  • European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma (EMA) (The Pink Sheet) (Fierce) (SCRIP Intelligence)
  • European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy (EMA) (BioCentury) (SCRIP Intelligence)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013 (EMA) (BioCentury)
  • Merck Sharp and Dohme Calls For Preventing 'Blatant' India Patent Violations Like Glenmark's (PharmAsia News)
  • Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA)
  • Fatality as blast rocks Teva manufacturing plant (PharmaFile)
  • Aegerion Gets EU Vote on Cholesterol Disorder Drug (PharmPro) (Boston Biz Journal)
  • ANALYSIS: a new type of dialogue emerges in EU IVD debate (Clinica)
  • Antiepileptic Drug E Keppra® Tablet Approved in Japan for Pediatric Epilepsy (Partial-Onset Seizures) (Otsuka)
  • Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Otsuka)
  • Sanofi pulls the plug on two late-stage drugs (Reuters) (SCRIP) (Pharma Times)
  • Medicines to be focus of next WHO safety challenge (Pharmaceutical Journal)
  • Doctors in Hyderabad express concern over quality of generic drugs (PharmaBiz)

General Regulatory and Interesting Articles

  • 15 Scariest Looking Medical Devices (Likes)
  • Wow of the week: New prosthetic rewires nerves to help users feel objects (Med City News)
  • Vinegar cervical cancer test will save thousands (Pharma Times) (Forbes)

Regulatory Reconnaissance #79 - 3 June 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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