Omeros Corp. began its transformation from a drug development company to a commercial venture Monday after the FDA green-lighted Omidria (phenylephrine and ketorolac injection) 1 percent/0.3 percent. The drug, formerly OMS302, was approved to maintain pupil size during cataract surgery or intraocular lens replacement (ILR) by preventing intraoperative pupil constriction, or miosis, and to reduce postoperative pain. Read More
CHICAGO – With immuno-oncology all the rage, especially against melanoma, at the 50th annual meeting of American Society of Clinical Oncology, the pairing of potential new compounds with ipilimumab (Yervoy, Bristol-Myers Squibb Co.) proved a popular ploy. Read More
Ariad Pharmaceuticals Inc. provided positive clinical data for Iclusig (ponatinib). The drug had a rocky start after receiving a December 2012 approval for use in patients with chronic, accelerated and blast phases of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) whose disease is resistant or intolerant to tyrosine kinase inhibitors (TKIs). Read More
Positive new phase III data showing Adherex Technologies Inc.'s sodium thiosulfate (STS) reduced hearing loss in children with cancer on cisplatin chemotherapy moved the company a step closer to filing a new drug application for the orphan drug next year. If approved it would become the first such therapy available in the U.S. Read More
CHICAGO – Melanoma was the first cancer type in which immunotherapy went from promise to breakthrough, and the American Society of Clinical Oncology (ASCO) went back to those roots in its Monday press briefing, highlighting studies that explored the use of immunotherapy's founding father, Yervoy (ipilimumab, Bristol-Myers Squibb) in new ways, as well as other promising immunotherapies. Read More
Instead of finalizing its draft guidance on human drug development under the Animal Rule, the FDA is revising the 6-year-old proposed recommendations. Read More
Elevated glucose levels emerging in roughly one-fourth of lung cancer patients receiving Clovis Oncology Inc.'s next-generation EGFR inhibitor CO-1686 may have overshadowed the promising interim progression-free survival (PFS) rate presented at the American Society of Clinical Oncology meeting over the weekend, at least on Wall Street, but analysts say the targeted covalent inhibitor remains a contender against Astrazeneca plc's AZD9291. Read More
CHICAGO – Efficacy plus an acceptable safety profile add up to the prime outcome from a trial, but there's much value in lesser attempts, said Gregory Masters of the Helen F. Graham Cancer Center in Newark, Del., as he found himself defending the choice of a spotlighted study at the 50th annual meeting of the American Society of Clinical Oncology (ASCO) over the weekend. Read More
Orion Corp., of Espoo, Finland, and Bayer AG, of Berlin, entered a global agreement for the development and commercialization of ODM-201, an oral androgen receptor inhibitor in development for treating patients with prostate cancer. Read More
Relypsa Inc., of Redwood City, Calif., said it secured a loan facility of up to $35 million with Oxford Finance LLC and Silicon Valley Bank (SVB). Read More
Incyte Corp., of Wilmington, Del. announced that preliminary results from an ongoing phase I/II study of INCB24360, its oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with ipilimumab in patients with unresectable or metastatic melanoma, showed the combination was generally well tolerated and produced evidence of clinical response. Read More
Alkermes plc, of Dublin, reported the start of a second phase II study of its broad-spectrum oral antipsychotic ALKS 3831 in development for schizophrenia. It will assess the compound's efficacy, safety and tolerability in treating schizophrenia in patients with co-occurring alcohol use disorder, compared to olanzapine, an approved antipsychotic medicine. Read More
Forest Laboratories Inc., of New York, reported that a pivotal phase III trial testing a combination of nebivolol and Basel, Switzerland-based Novartis AG's Diovan (valsartan) met its primary and key secondary endpoints, demonstrating statistically significant reductions from baseline in diastolic and systolic blood pressure vs. both nebivolol alone and valsartan alone at eight weeks in patients with hypertension. Read More