Regulatory Recon: FDA Clears Robotic Exoskeleton That Allows Paralyzed to Walk (27 June 2014)
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In Focus: US
- Robotics milestone: FDA clears motorized exoskeleton to help lower body paralysis patients walk (FDA) (Press) (MedCity News) (MedPage Today) (NBC) (Mass Device) (Bloomberg)
- Ranbaxy’s Ohm receives FDA approval for generic of Novartis’ Diovan (Pharma Letter-$) (SCRIP-$) (PharmAsia-$) (Fierce) (India Times) (Reuters) (Bloomberg)
- FDA planning DMD guidance (BioCentury)
- Challenges of pediatric formulations: A FDA science perspective (Journal)
- Deadly weight-loss pill DNP returns (Consumer Reports)
In Focus: International
- CHMP Releases Decisions, Recommends Six New Drugs for Approval (EMA)
- EU member states fall short on medical device market surveillance (Clinica-$)
- India Defers Primary-Level Drug Serialization (TraceLink) (PharmaBiz)
- Takeda Releases Report on Improper Drug Ads, but Only in Japanese (Pharmalot)
- Health Canada keeps flu plant inspection report secret (The Star)
US: Pharmaceuticals and Biotechnology
- Finding the Cause of Thrombosis in Some Immunoglobulin Treatments (FDA)
- Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013 (Journal)
- Challenges of pediatric formulations: A FDA science perspective (Journal)
- Ranbaxy’s Ohm receives FDA approval for generic of Novartis’ Diovan (Pharma Letter-$) (SCRIP-$) (PharmAsia-$) (Fierce) (India Times) (Reuters) (Bloomberg)
- Pfizer Says it Wants to Provide Clinical Data Summaries to Patients, but FDA Concerned (Twitter)
- FMT Advocates Concerned FDA Guidance Will Destroy Fledgling Industry (AP)
- PhRMA: Better Guidance Needed For FDA's Compassionate Use Program (IHP-$)
- Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study (PubMed)
- FDA planning DMD guidance (BioCentury)
- Holy Moly! Buckle Up! The Blip Turns Out to Be Mount Everest with about 600 ANDAs in June so Far! (Lachman)
- Thinking About the Broader Picture - Will GDUFA Have an Impact on PDUFA? (Lachman)
- FDA Focuses ANDA Reviews on Basis of Risk (Gold Sheet-$)
- FDA Aggressively Looking for Data Integrity Problems in Inspections (Gold Sheet-$)
- Industry Piloting “Balanced” Set of Pharmaceutical Quality Metrics (Gold Sheet-$)
- Recall for Ferring Pharma's Tev-Tropin Due to Chemical Contamination (FDA)
- Actavis Recalls Vancomycin HCl Due to Subpotency (FDA)
- FDA AdComm to Discuss Baxter's HyQvia for Immune Deficiency Disorders (FDA)
- FDA AdComm to Discuss BI's NDA for Tiotropium Bromide Inhalatation Spray for COPD (FDA)
- Biogen MS blockbuster Tecfidera earns high marks for safety (Fierce)
- Hypoglycemia in Patients Treated with Linezolid (Journal)
- FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving (FDA)
- Piramal Critical Care Inc recalls veterinary product in US (India Times)
US: Pharmaceuticals and Biotechnology: General
- Non-profits push for drug repurposing for neurodegenerative diseases (BioCentury)
- RiverVest finds success in blowing the dust off old compounds (MedCity News)
- U.S. Health Coalition Releases New Resource on Acetaminophen, America's Most Common Drug Ingredient (Press)
- New drug policy too burdensome, hospices say (Reuters)
- Some Calif. Pharmacies Do Not Offer Written Translations of Rx Labels (CA Healthline)
US: Medical Devices
- Robotics milestone: FDA clears motorized exoskeleton to help lower body paralysis patients walk (FDA) (Press) (MedCity News) (MedPage Today) (NBC) (Mass Device) (Bloomberg)
- Despite snag with FDA, 23andme marching on (BioWorld)
- FDA Teams Up for Novel Campaign on Risks of Decorative Contact Lenses (FDA)
- FDA AdComm to Meet Over Cohera Medical's TissuGlu Surgical Adhesive PMA (FDA)
- Encision Receives FDA 510(k) Approval on its AEM EndoShield Burn Protection System (Press)
- Siemens Files PMA for Digital Breast Tomosynthesis (Press)
US: Dietary Supplements
- FDA New Dietary Ingredient Rejections Draw “Roadmap” For Successful Notifications (Tan Sheet-$)
- Deadly weight-loss pill DNP returns (Consumer Reports)
- Is The Nutritional Supplement Industry Feeding You Bull Balls For Breakfast? (Forbes)
- US: Assorted And Government
- FDA Recalls Food. All of it. (The Onion) (Satire)
- Enforcement Report - Week of June 25, 2014 (FDA)
Europe
- CHMP Releases Decisions, Recommends Six New Drugs for Approval (EMA)
- CHMP Signs off on Approval of First Biosimilar Insulin in the EU: Abasria (EMA)
- Avastin first biologic backed in EU for resistant ovarian cancer (PMLIve) (Pharma Times) (Press) (Reuters) (WSJ-$)
- Lilly Wins EU Backing for Generic of Sanofi’s Lantus (Bloomberg) (Reuters)
- Vertex Receives European CHMP Positive Opinion for KALYDECO (ivacaftor) in Eight Non-G551D Gating Mutations (Press)
- European Medicines Agency recommends approval of BMS's Daklinza in chronic hepatitis C (EMA) (Press)
- Triumeq (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV (Press)
- Pfizer, Bristol clot drug wins EU green light for wider use (Reuters) (Press)
- Bayer Receives positive CHMP Opinion for the Treatment of Visual Impairment due to Diabetic Macular Edema in EU (Press)
- Bayer's Stivarga endorsed for gastrointestinal stromal tumors (Reuters) (Press)
- EU member states fall short on medical device market surveillance (Clinica-$)
- UK’s NICE draft guidance backs Novartis’ Glivec for GISTs (Pharma Letter-$) (SCRIP-$)
- NICE backs Janssen’s once-daily diabetes drug (PMLive)
- Janssen Submits EU Marketing Application for VELCADE (bortezomib) in Mantle Cell Lymphoma (Press)
India
Japan & China
- Takeda Releases Report on Improper Drug Ads, but Only in Japanese (Pharmalot)
- Gilead submits for approval of hepatitis C drug Sovaldi in Japan (Pharma Letter-$) (Press)
Canada
- Health Canada keeps flu plant inspection report secret (The Star)
Clinical Trials
- Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study (PubMed)
- Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013 (Journal)
- Room for improvement in breast cancer clinical trial design: taking advantage of the preoperative setting (PubMed)
- Clinical Trial Transparency Update: Eli Lilly, Bayer, Boehringer, and BMS Join Pharmaceutical Companies Sharing Patient-Level Clinical Trial Data (Policy and Medicine)
- Clinical trials: More Trials, Fewer Tribulations (Scientific American)
- Philips, Salesforce.com to create clinical, cloud-based platform (Fierce)
- New approach to clinical trials could boost participation (MNT)
Regulatory Reconnaissance #346 – 27 June 2014
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.
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