Shares of Alexza Pharmaceuticals Inc. jumped 29 percent Wednesday after the firm disclosed a U.S. commercialization partner for recently approved Adasuve, a version of antipsychotic drug loxapine delivered via the company's Staccato technology. Read More
With Phase II trials on the runway for several forms of adult and pediatric cholestatic liver disease, a rare condition for which no therapy exists, Lumena raised $23 million in a Series A financing that is expected to get the company through those studies, after which the firm will deliberate the matter of whether to bring aboard a partner in the rare-disease effort. Read More
Responding to drugmakers' growing interest in pediatric trials, the Biotechnology Industry Organization (BIO) is teaming up with the ViS Research Institute on a two-phase initiative to tackle the biggest challenge in conducting the trials – finding qualified sites that can recruit pediatric subjects. Read More
Oncobiologics Inc. allied with Zhejiang Huahai Pharmaceutical Co. Ltd. to develop, manufacture and commercialize biosimilar monoclonal antibody products equivalent to Humira, Rituxan, Avastin and Herceptin in a rapidly expanding subsector which has reached $2.4 billion – a 20 percent increase from 2012. Read More
Cardio3 BioSciences (C3BS) closed a €19 million ($25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. Read More
• Portola Pharmaceuticals Inc., of South San Francisco, Calif., reported safety and efficacy data from a Phase II proof-of-concept study of PRT4445 of Eliquis (apixaban) in healthy volunteers. Eliquis is a Factor Xa inhibitor. Anticoagulation markers and plasma concentration levels of Eliquis indicate that PRT 4445 results in a rapid, sustained, dose-related reversal of anticoagulant activity of Eliquis. There were no serious adverse events. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., said the biologics license application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet was accepted for review by the FDA. Read More
• pSivida Corp., of Watertown, Mass., said Iluvien (fluocinolone acetonide intravitreal implant) was launched in Germany in chronic diabetic macular edema by licensee Alimera Sciences Inc., of Atlanta. Earlier this month, Alimera resubmitted the new drug application for Iluvien, which has a PDUFA date of Oct. 17. Read More
• Pacira Pharmaceuticals Inc. reported total revenues for the quarter ended March 31, 2013, were $11.6 million compared with $7.8 million for the quarter ended March 31, 2012. The increase in revenues was primarily driven by $10.4 million of net product sales of Exparel (bupivacaine liposome injectable suspension) in postsurgical analgesia. Read More
