Just a couple of weeks after the FDA’s Oncologic Drugs Advisory Committee voted overwhelmingly in favor of supporting approval of Genentech Inc.’s supplemental biologics license application (sBLA) for Perjeta (pertuzumab) in neoadjuvant treatment of breast cancer, the FDA granted accelerated approval of the drug.
It wasn’t all that long ago that Amgen Inc. and Genentech Inc., prior to its acquisition by Basel, Switzerland-based Roche AG, both commanded impressive $100 billion market caps. Since that milestone was reached, valuations of the public biotech companies have declined, until recently that is.
It has been just over a year since the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. Contained within the act is a breakthrough therapy (BT) designation, intended to expedite the development and review of drug candidates, which has certainly found favor among biopharmaceutical companies.
The sky is getting crowded as biotech companies on the initial public offering (IPO) runway continue to take off with increasing regularity. The latest to get airborne is Cambridge, Mass.-based Acceleron Pharma Inc., which priced its IPO Thursday.
Global concern that R&D on new antibiotics has languished in recent years has certainly not escaped the attention of policymakers. The UK, for example, became the latest country to add its voice to the growing crisis about antimicrobial resistance by releasing a five-year strategy last week to address the critically thin pipeline of new antibiotics and the increasing incidence of infections that are becoming more and more difficult to treat.
A great deal has transpired in the antibiotics world since the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) last convened one year ago. As researchers and antibiotic drug developers alike meet in Denver this week for the annual meeting, the focus is squarely on new product pipeline progress and whether those innovative products nearing the marketplace will be enough to alleviate the growing concern about multidrug resistance in virulent bacteria.
Basel, Switzerland-based Roche AG is partnering with Inovio Pharmaceuticals Inc. and will develop DNA-based vaccines INO-5150, targeting prostate cancer, and INO-1800, targeting hepatitis B.
In the new health care ecosystem where, among other things, drug developers now need to show real-world value, companion diagnostics are evolving as essential components in order for new innovative drugs to prove their worth. This is because they enable these therapies to be targeted to patients who will benefit the most.
A great deal has transpired in the antibiotics world since the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) last convened one year ago. As researchers and antibiotic drug developers alike head to Denver this week for this annual meeting the focus will be squarely on new product pipeline progress and whether these innovative products nearing the marketplace will be enough to alleviate the growing concern about multidrug drug resistance in virulent bacteria.
New York-based Intra-Cellular Therapies Inc. (ITI), a biopharmaceutical company focused on the development of therapeutics for CNS disorders, generated gross proceeds of approximately $60 million from a private placement, which included the sale of approximately 18.9 million shares of its common stock to new and existing investors and approximately $15.3 million in bridge notes that converted into common stock at the closing.
