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The Justice Department has charged two people with murder and 12 others with serious crimes over alleged manufacturing violations at the New England Compounding Center (NECC) that led to 64 deaths due to meningitis and sparked a federal law to reign in large compounders. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized yesterday. Read More
A leaked draft of the Trans Pacific Partnership trade agreement gives far too much intellectual property protection to brand drugmakers at the cost of generic competition, GPhA said Wednesday in a letter to the Obama administration. Read More
China’s FDA is threatening to severely punish companies that illegally manufacturer and sell codeine in the country, a warning the follows several revelations of the product was being sold in bulk quantities. Read More
The FDA wants manufacturers to stop sending paper prescribing information to pharmacists and physicians who often don’t read it and only submit it electronically to the agency, a move that would create a single source for accurate labeling that would always be up to date. Read More
In their second reversal in a week, British healthcare cost monitors are now recommending Bayer’s prostate cancer drug Xofigo for men with hormone-relapsed prostate cancer and symptoms of bone metastases for whom docetaxel chemotherapy has failed. Read More
Teva’s first-filer rights to generic Celebrex are in doubt after a federal appeals court struck down a lower court’s decision upholding an FDA finding that the Israeli drugmaker was entitled to exclusivity on the blockbuster arthritis therapy. Read More
The FDA has approved Swiss drugmaker Novartis’ long-acting-release form of Signifor to treat the rare and life-threatening hormonal disorder acromegaly, following its approval in Europe last month. Read More
European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations. Read More