An FDA warning letter is an ignominious sign for any company and a wake-up call for change. But two warning letters in one year? That’s an alarm bell for most companies—a fact that a Pennsylvania-based drugmaker is finding out the hard way after a new FDA notice. FDA investigators accused KVK-Tech of failing to set… Read More: FDA nails Pennsylvania generics maker with 2nd warning letter in… »
Pharmaceutical giant Purdue Pharma has filed for Chapter 11 bankruptcy as part of a tentative agreement to settle thousands of lawsuits over its role in the opioid crisis. The company responsible for OxyContin announced Sunday it filed for bankruptcy protections just days after agreeing to terms with state attorneys general in over 2,000 lawsuits that… Read More: OxyContin maker Purdue Pharma files for bankruptcy »
SHANGHAI (Reuters) – A Chinese drug company produced nearly 500,000 substandard vaccines for babies, roughly double an earlier estimate by authorities investigating a safety scandal, state news agency Xinhua reported on Wednesday. China’s drug regulator in July accused Changsheng Bio-technology Co Ltd of selling 252,600 doses of ineffective DPT vaccines to inoculate children against diphtheria,… Read More: Chinese vaccine maker made 500,000 substandard baby vaccines: Xinhua »