Alkermes plc’s just-won fast-track status for its depression drug, Alks 5461 – along with the willingness of the FDA to let the company skip the end-of-Phase II meeting and move directly into Phase III, as outlined in the firm’s briefing documents – have brought the pivotal trial’s design into the spotlight.
Alkermes plc’s plan, unveiled this summer, to “retool” its opioid drug R&D got its first vote of confidence from the FDA, which is letting the company forgo the customary end-of-Phase-II meeting and move directly into Phase III trials with Alks 5461 for refractory major depressive disorder (MDD).
Versartis Inc., which holds worldwide rights to the long-acting recombinant human growth hormone (rHGH) VRS-317, may take the treatment for growth hormone deficiency (GHD) all the way to approval and marketing by itself, said Srinivas Akkaraju, general partner with Sofinnova Ventures, a new investor in the company’s $20 million Series D round.
Powered by a deal with Pfizer Inc., Glycomimetics Inc. is looking to solidify further its position in the race for therapies that would treat vaso-occlusive crises (VOCs) in sickle cell disease (SCD). The Gaithersburg, Md.-based company, which filed for a proposed initial public offering (IPO), but did not specify the targeted number of shares or price range, is developing GMI-1070 (rivipansel sodium) with Pfizer, of New York.
Celgene Corp. put still more chips on the biotech table, entering a confirmed $35 million deal to develop cancer and fibrotic-disease therapies with Pharmakea Therapeutics Inc., which at the same time pulled down $10 million in a Series A funding round from Bay City Capital.
Series A funding of $33 million will let Loxo Oncology Inc. move its lead compound through proof-of-concept research and push another into the clinic over the next three years or so, but the Delaware-incorporated firm still is not disclosing more about them.
I’m terrified of hospitals. Not so many years ago, this would have been an absurd remark. With doctors and high-tech medical care all around, a hospital seemed like one of the safer places in the world to be. But then, not so many years ago, age-related macular degeneration likely would have blinded many patients, as it did my late grandfather, pre-Macugen, pre-Lucentis. Things change, and not always for the better. The rise of resistant infections, especially the hospital-haunting and deadly methicillin-resistant Staphylococcus aureus (MRSA) has kept drug developers scrambling for new weapons against this bug and others. Until lately, the...
The latest to price its initial public offering (IPO), Fate Therapeutics Inc. garnered about $39.6 million, an amount at the low end of its already-dipped target range, selling about 6.6 million shares at $6 each.
As Achillion Pharmaceuticals Inc.’s stock reeled from the FDA’s refusal to lift the clinical hold imposed this summer on the hepatitis C virus (HCV) candidate sovaprevir because of elevated liver enzymes, analysts mulled the larger meaning and the company sought to reassure investors during a conference call.
The antibiotic dalbavancin’s long road to approval seems likely to end near the end of next May, now that Durata Therapeutics Inc. has submitted the new drug application (NDA) for the drug targeting acute bacterial skin and skin structure infections caused by gram-positive microorganisms, including the hospital scourge known as MRSA: methicillin-resistant Staphylococcus aureus.
