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The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
The head of the European Medicines Agency was forced to resign after a tribunal found he was improperly selected in 2011, a move agency officials characterized as a procedural issue. Read More
The drug pricing authority of India is calling on industry, public health experts and others to help update the country’s list of life-saving and essential drugs, a move that one observer says is needed to understand which drugs are on the market and under price controls. Read More
English health authorities next month will decide whether to stop reimbursing 25 cancer drugs because they are too expensive, a decision that has riled manufacturers who believe it will restrict patient access to treatments. Read More
Genentech’s cancer drug Avastin won approval Friday to treat platinum-resistant, recurrent ovarian cancer in combination with chemotherapy, marking the eighth time the FDA has greenlighted the blockbuster product. Read More
A California jury found that Johnson & Johnson subsidiary McNeil Inc. was not guilty of manufacturing a defective Tylenol product that a family claims led to a child’s death. Read More
The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the products. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
Amgen and AstraZeneca said their experimental psoriasis compound brodalumab demonstrated better outcomes than Janssen’s therapy Stelara in a Phase III trial, a development that moves the drug one step closer to market in the competitive therapeutic area. Read More
Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders. Read More
The FDA approved two sNDAs for Johnson & Johnson’s antipsychotic Invega Sustenna to treat patients with schizoaffective disorder, which will help the drugmaker offset lower sales of its neurological treatments due to generic competition. Read More