Citing safety and quality concerns, Swiss-based Roche has won a temporary injunction from the Delhi High Court to block the expected launch of a biosimilar of breast cancer drug Herceptin (trastuzumab) by Reliance Life Sciences, the Economic Times reports.
GlaxoSmithKline and partner Isis Pharmaceuticals are plotting a pivotal trial in the rare TTR amyloid cardiomyopathy, an inherited disease that impairs the heart muscle.
The FDA and DOJ keep banging away on the prosecutions of more than 30 people arrested for their alleged parts in a huge scheme that bought drugs off the street, repackaged them and put them back into the U.S. supply chain.
Amgen's Imlygic became the first genetically modified oncolytic viral therapy to earn FDA approval.
Chinese health officials shed some additional light on the country's plans to reform its healthcare system by saying they plan to implement a "multilevel" system for medical treatment, according to a press briefing given by State Council officials.
In this day of instant gratification, instant feedback via social media and fast food and fast fashion, General Electric wants to add fast prefabricated drug manufacturing plants to the list.
Novartis announced FDA approval last week of its Utibron Neohaler as a long-term maintenance treatment for COPD via the delivery of the bronchodilating agents indacaterol and glycopyrrolate.
The FDA and European regulators, which have long had concerns about the quality of drugs being manufactured by Chinese companies, are now finding issues at some Chinese plants owned by Big Pharma. The FDA has cited a Pfizer plant in China, while U.K. regulators recently found shortcomings at a GlaxoSmithKline plant there.
The FDA is seeking input from stakeholders on the optimal use of new-era technology during clinical trials, including mobile health tools, telemedicine and remote sensors.
Mainstay Medical is eyeing European approval for its implantable neuromodulation device, submitting an application for a CE mark in a bid to expand global commercialization for its product.