There is plenty of evidence to suggest that small and emerging biotechnology companies could significantly benefit from modifications to the existing SEC rules and regulations affecting their access to the capital markets.
San Francisco-based Medivation Inc. and Astellas Pharma Inc. had plenty to celebrate heading into the Labor Day holiday weekend. The FDA on Friday approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel three months ahead of the product's prescription drug user fee goal date of Nov. 22.
Since the beginning of the year a significant amount of research data has been reported on histone deacetylases (HDACs), the cellular enzymes whose functions include turning gene expression off and on. They are considered to be among the most promising targets in drug development for cancer therapy. New HDAC inhibitors are emerging and are actively being tested in the clinic.
Despite the availability of advanced molecular technologies and the investment of billions of dollars in research and development every year, biopharmaceutical companies have not yet managed to improve their efficiency rate for bringing novel therapies to the marketplace.
Although multiple treatment options are currently available for people suffering from rheumatoid arthritis (RA), there will always remain room for effective new therapies.
Finding next-generation treatments for pulmonary arterial hypertension (PAH) is proving to be difficult. Last week two companies made the point. Gilead Sciences Inc. terminated a Phase II trial of cicletanine for PAH due to a failure of the trial to meet its primary endpoint of improvement in exercise capacity; and Novartis AG pulled its new drug application (NDA) for QTI571 (imatinib mesylate) for PAH treatment.
Although multiple treatment options are currently available for people suffering from rheumatoid arthritis (RA), there will always remain room for effective new therapies.
Biotechnology companies have an insatiable appetite for cash to fuel their drug development programs. However during the past several years, apart from the industry's "blue chip" companies, the majority of biotechs have been forced into a strict diet as financing has become more difficult and costly to secure. With follow-on financings becoming challenging and costly to complete given the current state of the capital markets, publicly listed companies are turning to alternative forms of financing. One of these vehicles is at-the-market (ATM) financing.
It certainly has been a wild ride for RNA interference (RNAi), a unique class of therapeutics believed to be the next wave of novel medicines. From the initial euphoria about the technology with its huge potential for the development of targeted therapeutics for cancer and other diseases, we have witnessed a reality check in recent years as serious challenges began to surface related to the problems of finding effective delivery of these constructs to their intended targets.
The numbers are staggering – approximately 100 million Americans suffer from chronic pain conditions, and the annual economic toll of pain can be as high as $635 billion in medical bills and lost productivity, according to a report from the Institutes of Medicine. (See BioWorld Today, March 13, 2012.)
