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Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More
The European Commission has approved Eli Lilly’s self-injectable diabetes drug Trulicity, a move that follows the FDA’s approval in September. Read More
India’s drug pricing authority has proposed adding 12 cancer drugs to its list of essential therapies that are subject to price controls, while removing three under-utilized drugs. Read More
The European Medicines Agency wants to improve the access to its unpublished documents, but still reserves the right to refuse a request if disclosure would undermine protected information such as the purpose of an investigation or audit into a company. Read More
By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More
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