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The European Commission will revise four annexes to its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
Australia’s Therapeutic Goods Administration has adopted 10 EU guidelines, four that are new for the country and six that replace existing guidelines. Read More
The UK’s healthcare cost authority has reversed itself and is recommending Boehringer Ingelheim’s Vargatef in combination with docetaxel for previously treated, locally advanced metastatic or locally recurrent non-small cell lung adenocarcinoma. Read More
A federal judge denied a request by health plans and other payers for class certification in antitrust litigation involving Cephalon’s Provigil, less than a week after the drugmaker settled with the Federal Trade Commission for $1.2 billion over pay-for-delay claims involving the blockbuster sleep disorder drug. Read More
AbbVie filed a citizen petition Wednesday urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
A judge dismissed claims that the FDA is precluded from approving generic versions of Otsuka’s blockbuster antipsychotic until its orphan exclusivity expires. Read More