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The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
The European Commission has approved Roche’s Kadcyla to treat patients with HER2-positive locally advanced or metastatic breast cancer previously treated with Herceptin and/or a taxane. Read More
Positive results from the first long-term trial of evolocumab, Amgen’s next-generation heart drug, are heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More
Kadmon Pharmaceuticals has once again been warned by the FDA for making misleading claims in advertisements, this time for omitting risk information and falsely implying that its hepatitis C drug Ribasphere is a monotherapy. Read More
The wrangling over trial design guidance for gene/cell therapies will extend into next year as the FDA tries to satisfy industry concerns about how elements of the trials can be standardized. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
Illinois-based drugmaker Horizon Pharma has acquired the U.S. rights to AstraZeneca’s Vimovo delayed-release tablets in order to bolster the company’s primary care portfolio. Rights outside the U.S. will be retained by AstraZeneca. Read More
In the wake of record-breaking numbers of drug shortages, particularly generic injectables, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is advising drugmakers to establish a drug shortage task force. Read More
Drugmakers will soon have to seek Federal Trade Commission antitrust review for all proposed licensing agreements for “exclusive” patent rights. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More
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