Recommendation by panel to be sent to health minister for inclusion in Drugs & Cosmetics Act Indian manufacturers and importers of medical devices will soon have to compensate patients for serious side effects of their products. On Wednesday, an…
MHRA says Avastin can be used for AMD, despite Bayer, Novartis objections
The UK drugs regulator has endorsed the use of Roche’s Avastin as a treatment for age-related macular degeneration, a leading cause of blindness, even though it isn’t approved for that use. The Medicines and Healthcare products Regulatory Agency (MHRA) looked…
Takeda eyes emerging markets asset sale to trim its debt; report
Takeda is said to be considering the sale of assets in emerging markets and western Europe to pay down some of the debt it has taken on with the $62 billion acquisition of Shire. Bloomberg suggests the Japanese drugmaker could…
Clinical Research and Clinical Care: Carving a New Approach
Bridging the gap between clinical care and clinical research may not be that far away. The future of clinical trials will mean carving a new approach to how patients and doctors view clinical research, which will be a much more…
Jazz Pharma Hits the Mark with Another Narcolepsy Treatment
An investigational medicine in late-stage development by Jazz Pharmaceuticals hit the mark in treating cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy. The drug also has the benefit of a lower sodium content, which is crucial due to…
Novartis in political row after denying Belgian toddler compassionate access to gene therapy
The controversy over Novartis’ ultra-pricey gene therapy Zolgensma has intensified after it allegedly refused to supply the one-off therapy to a sick toddler in Belgium on compassionate grounds. According to The Brussels Times, the family of the toddler named Pia,…
Drug firm on trial over weight loss pill linked to 2,000 deaths
A landmark trial over a weight-loss pill believed to have killed as many as 2,000 people begins today. French pharmaceutical giant Servier stands charged with corporate manslaughter and other offences over deaths allegedly linked to its Mediator slimming drug. France’s…
FDA takes first action under new international collaboration with Australia and Canada
The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project,…
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications…
Expert Committees Need Expert Management
As sponsors and CROs make increasing use of expert committees — especially Endpoint Adjudication Committees (EAC) and Data Monitoring Committees (DMC), they are asking, “What makes an expert committee successful?” Who better to answer that question than the experts who…
