With a new drug application (NDA) recently filed for Captisol-enabled melphalan (CE melphalan) in multiple myeloma (MM) and SPI-2012, a long-acting granulocyte stimulating factor (G-CSF) said to have billion-dollar potential, going into phase III trials next year for chemotherapy-induced neutropenia, Spectrum Pharmaceuticals Inc.'s only cloud on the horizon seems to be the patent battle over the folate analog Fusilev (levoleucovorin) in cancer.
With favorable results in hand from a phase IIa pharmacokinetic (PK) study with its Parkinson's disease (PD) treatments, Neuroderm Ltd. is planning a head-to-head trial against Abbvie Inc.'s Duodopa – cleared in Europe, pending in the U.S. – next year, Oded Lieberman, CEO of the Rehovot, Israel-based firm, told BioWorld Today
Aiming for success in female sexual dysfunction (FSD) after hitting roadblocks with U.S. regulators in erectile dysfunction (ED), Palatin Technologies Inc. is drawing from the $20 million raised last week in equity, along with $10 million in debt, to launch a phase III, 550-patient study that will test bremelanotide (BMT) in an eight-month experiment with an open-label extension phase.
Another vote for cancer immunotherapy came in the form of $50 million in class A stock-sale money for Conkwest Inc., including $48 million from Nantworks Inc. founder and well-known biotech entrepreneur Patrick Soon-Shiong plus $2 million from Sorrento Therapeutics Inc.
As the smoke clears from the resolution of Vanda Pharmaceuticals Inc.'s tussle with Novartis AG over the approved but weak-selling schizophrenia drug Fanapt (iloperidone), investors are turning their eyes toward AQW051, the phase II alpha-7 nicotinic acetylcholine receptor partial agonist that Vanda gained – along with a $25 million equity investment – in its settlement with the pharma giant.
Advances continued in the race for ever-better, oral, direct-acting hepatitis C virus (HCV) therapies with the approval Friday of Abbvie Inc.'s Viekira Pak to treat patients with chronic genotype 1 (GT1) infection, partnered with Enanta Pharmaceuticals Inc.
Merck & Co. Inc.'s deal to take over Oncoethix SA for $110 million up front and $265 million in potential milestone payments raised not only the increasingly high profile of bromodomain (BET) inhibitors, but also the hopes of others in the space for similarly lucrative deals.
Potential benefit with longer therapy for elderly patients with acute myeloid leukemia (AML) kept hope alive for them as well as Cyclacel Pharmaceuticals Inc., which heard from the data safety and monitoring board (DSMB) that the phase III study known as Seamless with lead candidate sapacitabine has crossed the futility boundary and is unlikely to reach a statistically significant level of survival.
The administrative interim analysis of three-month efficacy proved disappointing in Sophiris Bio Inc.'s 12-month phase III PLUS-1 trial with PRX302 (topsalysin) for benign prostatic hyperplasia (BPH), but CEO Randall Woods advised investors to "just sit tight for right now," since the peek is "just a snapshot" done for planning purposes.
The onslaught of new genomics information and what it means for figuring out how to come up with drugs for rare subsets of patients were subjects for an all-day public workshop sponsored by the FDA, which ended with few answers but included plenty of potentially useful interchanges between experts.
