The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted…
India to Add EU to List of Regions Covered by Clinical Trial Waiver
India is planning to add the European Union to the list of regions covered by its clinical trial waiver rule. The change will free companies from the need to run clinical trials of medical devices that are already available in…
NDEA and NDMA Impurities: Another Indian Manufacturer Receives an FDA Warning Letter
The fallout from the N-Nitrosodiethylamine (NDEA) and N-Nitrosodimethylamine (NDMA) impurities fiasco continues as the US Food and Drug Administration (FDA) last week sent a warning letter to India-based Lantech Pharmaceuticals. Lantech, which was placed on import alert in June and…
Changing Global Regulatory Landscape and Strategy for Drug and Device Operations
Biomedical research is advancing rapidly and a key part its advancement is in the analytical capabilities allowing comparison between a reference biological product and a biosimilar product. In “Comparison of Data Requirements for the Approval of a Biosimilar Versus the…
Jehangir Hospital joins Clinerion’s Patient Network Explorer
Jehangir Hospital, along with its research arm Jehangir Clinical Development Centre (JCDC), is bringing its patients access to international clinical trials by joining Clinerion’s Patient Network Explorer platform. JCDC is the research arm of Jehangir Hospital, Pune, India. The hospital…
FDA Approves First Myelofibrosis Drug in Nearly a Decade
Celgene’s $7 billion bet on San Diego-based Impact Biomedicines is paying off. This morning, the U.S. Food and Drug Administration (FDA) approved Impact’s Inrebic (fedratinib) for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone…
Report: Projected Sales of 10 Top-Selling Drugs Through 2024
Although some of the top-selling drugs in the world are facing patent cliffs between now and then, many of them are still projected to continue being big sellers between now and 2024. A recent report by Evaluate Pharma estimates prescription…
Soon, import, manufacture and sale of all medical devices may need CDSCO certification
Government’s think tank Niti Aayog has prepared a roadmap on medical devices, suggesting that all medical devices clear specific safety and quality standards As of now, only 23 devices are regulated In a bid to ensure quality, all imported…
More M&A Activity Expected Around AAV-Based Gene Therapies, Analyst Says
Gene therapy companies could be continued M&A targets for larger ones as more and more companies are looking to broaden their therapeutic focus with potential one-time therapies for various diseases. In a note to investors, Canaccord Genuity analyst Michelle Gilson,…
“A Devil of a Disease”: The Current Alzheimer’s Pipeline
As anyone following Alzheimer’s research knows, drug development for the disease has been a wasteland of failed clinical trials with literally billions of dollars thrown at drugs that have proved ineffective at preventing or halting the disease. In March 2019,…
