To substitute or not to substitute? Biotechs and biosim makers compromise on legislation
12 December 2014
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
12 December 2014
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
12 December 2014
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?
12 December 2014
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
11 December 2014
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.
Vaccine May Prevent Antibiotic Resistant Skin Infections
11 December 2014
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
11 December 2014
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.
Patent Cliff Means Pharmaceutical Companies Will Lose $65 Billion by 2019, says GlobalData
11 December 2014
Pharmaceutical companies will suffer an estimated $65 billion drop in sales by 2019 due to the patent expiries of several leading drugs, according to research and consulting firm GlobalData.
2013 New Molecular Enterties Summary Report (Charts) - FDA
10 December 2014
The charts below are pulled from the 2013 Novel New Drug Summary Report.
New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products of 2014
10 December 2014
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market.
NovaMedica expands its line of products for the treatment of Alzheimer’s disease
22 August 2024
Children visited the NovaMedica Innotech pharmaceutical manufacturing facility
14 June 2024
16 May 2024
06 September 2024
HPV vaccine is to be included in Russia’s national immunization schedule by 2026
06 September 2024
New WHO guidance to support manufacturers to reduce AMR risk
05 September 2024
05 September 2024