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The European Medicines Agency has approved an intramuscular long-acting form of Novartis’ Signifor for adults with the rare hormonal disorder acromegaly, which has not been controlled by surgery or older somatostatin analogue (SSA) therapies. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
Future FDA guidances on developing drugs for specific indications will include key milestones to help manufacturers set up their product development programs and guide potential talks with the review division. Read More
The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
The FDA will require large compounding pharmacies to register each year, pay a $15,000 annual fee and report a detailed list of all the products they manufacture every six months. Read More
Europe’s drug regulatory agency has revised the conflict of interest policy for its scientific committee members and experts, a move that one attorney says recognizes the reality that most knowledgeable specialists have at least some commercial involvement. Read More
An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
Generic versions of the Hoffman-La Roche AIDS drug Valcyte can move forward after a federal judge denied Ranbaxy’s request for a restraining order on alternate versions of the therapy, as well as AstraZeneca’s blockbuster heartburn drug Nexium. Read More