The implausibility of comparing data with would-be competitors from separate trials did not stop industry wizards from following their 'Inpulsis' and guessing anyway, with the upshot that overall chances seemed to ASCEND for Intermune Inc.'s Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF), over Boehringer Ingelheim GmbH's phase III outcomes with the tyrosine kinase inhibitor nintedanib.
Still signing up patients for its phase III trial with Fovista, the antiplatelet-derived growth factor agent that would be used with anti-VEGF therapy in wet age-related macular degeneration (AMD), Ophthotech Corp. pulled down a $200 million up-front ex-U.S. deal with Novartis AG that could be worth more than $1 billion, not including royalties, which are also part of the deal.
Kamada Ltd. execs said they hope a good secondary endpoint showing from the phase II/III trial in Europe and Canada with its inhaled therapy for alpha-1 antitrypsin (AAT) deficiency – when combined with results from an ongoing phase II study in the U.S. – will impress European regulators enough to grant approval.
With eagerly awaited abstracts unleashed on the world from the American Society of Clinical Oncology (ASCO) annual meeting, pundits and investors were ransacking the batch for clues to success. ASCO unveiled no fewer than 5,000 studies from which results were to be offered at the cancer meeting, which starts in about two weeks.
The already-bright hope for Bristol-Myers Squibb Co.'s (BMS) PD-1 checkpoint inhibitor nivolumab in non-small-cell lung cancer (NSCLC) was bolstered by a deal to test the compound with Celldex Therapeutics Inc.'s CD27-targeting varlilumab, on a day that saw another oncology deal in the same space between Incyte Corp. and Medimmune, part of London-based Astrazeneca plc.
Having scored landmark phase III success against Duchenne muscular dystrophy (DMD) with idebenone, an oral drug that does not depend on patients' mutational status, Santhera Pharmaceuticals AG is heading to the FDA to talk about next steps.
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).
