For more than a decade now the technologies associated with the regenerative medicine and cell therapy sectors have been hailed as the "future of medicine."
Last year the prevailing global economic woes did not prove to be much of an impediment for biopharmaceutical companies in their quest to generate capital with a total of $24.8 billion raised. However, the ongoing financial uncertainties in Europe coupled with a weak domestic economy, a U.S. presidential election and a long contentious debate over the "fiscal cliff" all contributed toward making it a challenging environment for companies looking for funding.
Last year the prevailing global economic woes did not prove to be much of an impediment for biopharmaceutical companies in their quest to generate capital with a total of $24.8 billion raised. However, the ongoing financial uncertainties in Europe coupled with a weak domestic economy contributed toward making it a challenging environment for companies looking for funding.
Our popular "Word on the Street" column provides a selection of the most entertaining and thought-provoking quotes that the BioWorld Today/BioWorld Insight staff publishes each week. Some are gathered during interviews, some gleaned from analyst reports, and some are overheard at conferences. They reflect the type of year we have had – certainly a challenging one if you were looking for venture capital.
Like Rodney Dangerfield, biotech companies achieving FDA product approval milestones are not getting much respect from investors these days. Take the case of Aegerion Pharmaceuticals Inc., of Cambridge, Mass.
Halozyme Therapeutics Inc. added another feather in its partnership cap with Pfizer Inc. inking a worldwide collaboration and license agreement to develop and commercialize products that combine their recombinant human hyaluronidase enzyme (rHuPH20) with biologics directed to up to six unnamed targets.
Millions of Americans live with pain that can often persist for years. Current treatment options that include opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are limited in their clinical effectiveness. In addition, there are important undesirable side effects and safety risks associated with the available treatments for acute and chronic pain, not the least of which is the expanding epidemic of prescription pain medicine misuse and abuse.
The FDA wants to hear from industry and other interested parties on what should constitute a "qualifying pathogen" that could trigger a range of incentives designed to encourage companies to develop new antibiotics targeting these designated pathogens.
Shares of Celldex Therapeutics Inc. gained 25.5 percent Monday – a reaction to the company reporting positive final data on CDX-011 in a Phase II study in metastatic breast cancer.
The biopharmaceutical industry is certainly on a productive roll as measured by its output of new medicines. The number of new drug approvals appears to be steadily increasing year-over-year. The rate at which the FDA has approved new molecular entities (NMEs) – including those filed under new drug applications (NDAs) and therapeutic biologics filed under original biologic license applications (BLAs) is already ahead of last year's total of 30 (24 NMEs, and six biologics).
