On the heels of a report from the World Health Organization (WHO) that warns about "superbugs" making inroads across the globe, Cubist Pharmaceuticals Inc. popped the lid off phase III data with its ceftolozane/tazobactam combo antibiotic at the 24th European Congress of Clinical Microbiology and Infectious Diseases.
The battle for obesity market share became unsurprisingly more complicated with the notice by Actavis plc that it has filed an abbreviated new drug application (ANDA) for all strengths of one of the market players: Vivus Inc.'s Qsymia (phentermine/topiramate).
As the initial public offering (IPO) flood slowed to a trickle, Alder Biopharmaceuticals Inc.'s $80 million deal did little to raise optimism, as the firm priced an upsized number of shares at a lower price to raise an amount far below the $115 million targeted in March, when the company filed to go public. The Bothell, Wash.-based firm hiked the number of shares from 7.2 million to 8 million, selling them at $10 each, under the projected $13-to-$15 range. (See BioWorld Today, March 20, 2014.)
Wider meaning of the 76 percent drop in first-quarter Testim sales related to the prospects for Testopel may not be simple, but Auxilium Pharmaceuticals Inc.'s former (a gel) is apparently on the skids and the latter (a long-acting implantable therapy) falls as well into a suddenly risky field: testosterone replacement therapy (TRT).
With $24 million of series B cash in hand, Loxo Oncology Inc. disclosed more about the pipeline's lead compound in a cancer effort than the company was willing when it garnered $33 million in the series A round last October.
As investors await Regeneron Pharmaceuticals Inc.'s first quarter earnings, due Thursday, the company disclosed an ophthalmology deal with gene therapy specialist Avalanche Biotechnologies Inc. that buys a time-limited right to first negotiations to phase II-stage AVA-101, targeting vascular endothelial growth factor (VEGF) for wet age-related macular degeneration (AMD).
Acorda Therapeutics Inc.'s second setback in less than a month came in the shape of a complete response letter (CRL) for the new drug application (NDA) related to Plumiaz (diazepam) for epileptic cluster seizures, and the company said the nasal spray version of the benzodiazepine therapy is unlikely to win approval this year.
As soon as Merrimack Pharmaceuticals Inc. unveiled strongly positive data from the NAPOLI-1 phase III trial with MM-398 in metastatic pancreatic cancer patients previously treated with gemcitabine, investors began to mull the chances for the drug – a nanoliposomal encapsulation of the chemotherapy agent irinotecan – in first-line disease.
After drawing $45.9 million in a series C financing round last September, Otonomy Inc. put another $49 million into the coffers by way of an oversubscribed series D round, which will let the San Diego-based firm advance its products for ear conditions "well into the second half of 2015," said CEO David Weber.
A rejiggered phase III Fabry disease trial with migalastat, the oral small-molecule chaperone for alpha-galactosidase A, did the trick for Amicus Therapeutics Inc., which reported favorable data in patients with the amenable mutations using the drug as a monotherapy.
