Latest Headlines

Latest Headlines

Roche gets temporary court injunction on Herceptin biosimilar in India

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.

Isis and GlaxoSmithKline eye Phase III with a rare disease drug

GlaxoSmithKline and partner Isis Pharmaceuticals are plotting a pivotal trial in the rare TTR amyloid cardiomyopathy, an inherited disease that impairs the heart muscle.

Feds nail 2 more in scheme that diverted illegal drugs into U.S. supply chain

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 becomes first re-engineered virus to earn FDA approval as a cancer fighter

Amgen's Imlygic became the first genetically modified oncolytic viral therapy to earn FDA approval.

China State Council briefing outlines multilevel system for medical treatment

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.

Ready-to-assemble GE drug plants hit the ground in China

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' inhaler for COPD gets FDA approval

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.

FDA cites Pfizer for shortfalls at Chinese manufacturing plant

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.

FDA seeks input on use of health IT and wearable tech during drug and device trials

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 sails toward CE mark for neuromodulation implant

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.