Industry news

EU drugs agency tightens rules on experts moving to industry jobs

Roshni Menon / Reuters

Europe's medicines regulator said on Wednesday it would restrict experts and committee members who intend to work for a pharmaceutical company from participating in the evaluation of medicines, in a move to reduce conflict of interests.

FDA makes strides in inspection effort but challenges persist

Eric Palmer / FeircePharmaManufactoring

Before a generic drug can make it to market in the U.S., the facility where it will be manufactured must be inspected and approved by the FDA. But with generic drug applications piling up, the agency is having trouble getting to many of those, although it is making progress in catching up.

China kicks press into high gear to knock down talk on higher drug prices

EJ Lane / FeircePharmaAsia

Within days after China announced an upcoming end to controls on most drug prices, whispers were heard of concerns the move set for June 1 would lead to higher prices at the consumer level. Government information outlets went into high gear to dampen the doubts.

Big new launches rocket cancer drug spending to $100B: IMS report

Carly Helfand / FiercePharma

Cancer drug pricing is turning more and more heads, especially as critical payers threaten a crackdown in the oncology field. And there's a reason for all the hullaballoo: Spending on oncology meds is increasing rapidly, new IMS numbers show.

Drug Discovery and Development in India

Jane Wan / BioPharm International

Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s when India announced the signing of the World Trade Organization (WTO) agreement that introduced a product patent system from Jan. 1, 2005. Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug discovery as contract agencies where in-house strengths in chemistry of local companies was augmented with focus biology”. 

New devices test drugs where they will need to work: inside tumors

Anette Breindl / BioWorld

Two independent teams of scientists have described microtechnologies that could allow the testing of multiple drugs and drug combinations directly within tumors – both xenografted tumors in animals and tumors that are still within the patients themselves.

China to lift most drug price controls in move aimed at safety, innovation

EJ Lane / FeircePharmaAsia

Price controls on most drugs sold in China will be lifted in June, the National Development and Reform Commission (NDRC) said on Tuesday, a move signaled earlier by Beijing as a way to tackle issues of safety and to encourage innovation among domestic companies.

India, Europe talks on IP tussles break down

EJ Lane / FeircePharmaAsia

India and a group of four European nations, including Switzerland, have broken off trade talks over a failure to resolve differences involving India's protections for intellectual property rights, particularly pharmaceuticals.

EMA Finds Scientific Advice Leads to Stronger Trial Design

BioPharm International

The European Medicines Agency (EMA) has released findings from its marketing authorization application analysis conducted between 2008 and 2012 by EMA’s Scientific Advice Working Party (SAWP). The findings, which were published in Nature Reviews Drug Discovery, state that companies that followed EMA recommendations for clinical development plans were more likely to be granted marketing authorization.

05 May 2015

Transcend Medical Announces Intent to File Premarket Approval Application with FDA for the CyPass® Glaucoma Micro-Stent

Transcend Medical, Inc. announced today its intent to file a premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the CyPass Micro-Stent, a novel minimally invasive glaucoma surgical (MIGS) implant. The company recently completed the COMPASS pivotal trial evaluating the device, demonstrating sustained and consistent positive results through two years. Transcend Medical expects to file the PMA application with FDA in the second half of 2015.