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Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
Teva Pharmaceuticals asked U.S. Supreme Court Chief Justice John Roberts Tuesday to recall and stay a July 2013 appeals court ruling invalidating a patent on Teva’s blockbuster multiple sclerosis drug Copaxone, pending the full court’s final decision on the patent case. Read More
Republican lawmakers April 1 blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More
The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More
Alkermes says its once-monthly injectable version of the antipsychotic blockbuster Abilify met its endpoints in a Phase III trial, setting it up for an NDA filing with the FDA sometime in the third quarter. Read More
The FDA is continuing its push to find ways to curtail opioid abuse, calling for suggestions and recommendations on innovative packaging, storage and disposal systems, technologies or designs that would thwart abusers. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
Takeda Pharmaceutical and Eli Lilly Monday were ordered to pay a combined $9 billion in punitive damages after a federal court jury found they hid the cancer risks of their Actos diabetes medicine. Read More