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Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27. Read More
Companies developing pediatric vaccines for diphtheria, tetanus and pertussis, or DTaP, can streamline the process by using a single dosing schedule in clinical trials, new guidance from the European Medicines Agency says. Read More
The day after CDER unveiled a sweeping blueprint to create investigative teams to conduct quality inspections, experts praised the reorganization, saying it will result in more detailed inspections, better guidance on addressing problems and fewer erroneous Form 483 observations. Read More
A federal judge has dismissed some claims in a case alleging Teva and Pfizer-subsidiary Wyeth forged an anticompetitive agreement to delay generic competition on Wyeth’s antidepressant Effexor XR. Read More
Regeneron Pharmaceuticals’ eye injection Eylea received an expanded indication from the FDA to cover macular edema following branch retinal vein occlusion. Read More
Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More
Generics firm Par Pharmaceuticals has agreed to pay Salix Pharmaceuticals $100 million to settle a patent infringement lawsuit over its version of Salix’s heartburn drug Zegerid. Read More
A European biotech association is calling on EU regulators to develop new guidance on the labeling of biosimilars that will end the practice of assigning a generic label to the complex products. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More