Industry news

Abbott, unfazed by political tensions, closes deal for Russia's Veropharm

Carly Helfand, FiercePharma

Mounting political tensions between Russia and the West may have recently scared Germany's Fresenius out of a partnership in the country. But they won't spook Abbott Laboratories ($ABT) out of its VeroPharm buy, it announced Friday.

Russian Ministry of Health reveals new classification of drugs for domestic market

ThePharmaLetter

It is planned that the new classification will be comprised of four drug categories, of which vital drugs, whose prices are regulated by the state, is expected to be one of the most important categories.

FDA creates expanded access working group

BioCenture

FDA has created a working group to develop policies that would improve access to investigational therapies, Richard Moscicki, deputy director for science operations at the agency’s Center for Drug Evaluation and Research, told BioCentury.

To substitute or not to substitute? Biotechs and biosim makers compromise on legislation

Carly Helfand, FiercePharma

Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.

Biotechs continue to increase their annual R&D expenditures

Peter Winter, BioWorld

The ongoing bullish period for the biotechnology industry has endured for the past two years and still shows no signs of slowing down. Over this period, public biotech companies have taken advantage of their skyrocketing share prices to carry out a significant number of follow-on financings.

Old dogs and new tricks: The real-world consequences of excluding older adults from drug trials

Marie Powers, Reuters

Many of the broadest categories of disease – cancer, heart disease, pulmonary disease, neurodegenerative disease – are largely diseases of aging, either of the body or of individual cells, yet drugs in development for these indications still are mostly tested in populations several decades younger than the primary end users.

Lack of trial diversity: Is it really an unavoidable reality?

Mari Serebrov, BioWorld

Diversity in clinical trials is a common refrain at advisory committee meetings these days, with panelists often recommending postmarket trials or subgroup analyses for minorities or patients with specific co-morbidities.

2014 in review – Biosimilars: steady, if unspectacular, progress

Simon King, FirstWord Pharma

If 2013 was a standout year for the biosimilars sector – the high point being approval of Celltrion and Hospira's biosimilar infliximab (Remicade) in Europe – then 2014 has witnessed something of a return to 'normality,' characterised by steady progress in some areas, but disappointment and delay in others.

11 December 2014

Vaccine May Prevent Antibiotic Resistant Skin Infections

Drud Discovery&Development

A study reported in the Proceedings of the National Academy of Sciences USA holds new hope for preventing or reducing the severity of infections caused by the “superbug” MRSA.  In the study, infectious disease specialists at the Los Angeles Biomedical Research Institute reported that a new investigational vaccine, NDV-3 (licensed to NovaDigm Therapeutics, Inc.), employing the recombinant protein Als3, can mobilize the immune system to fight off MRSA skin infections in an experimental mode.

Healthcare industry groups seek compatibility standards for medical devices

Joseph Keenan, FeirceMedicalDevices

With the explosion of new technologies in medical devices, particularly personal wearable products that connect to smartphones through apps, healthcare industry groups have begun searching for ways to make sure data can be shared easily from platform to platform.