Call it a draw between Cerexa Inc. and the FDA. On the second of a two-day meeting of the Anti-Infective Drugs Advisory Committee (AIDAC), representatives from the Actavis plc subsidiary saw combination antibacterial candidate ceftazidime-avibactam (CAZ/AVI) heartily endorsed to treat two types of serious infections caused by resistant gram-negative pathogens. Read More
Incyte Corp. has become the first company to win FDA approval for a treatment targeting uncontrolled cases of the rare chronic bone marrow cancer polycythemia vera (PV), which sometimes advances to myelofibrosis. Read More
With positive top-line phase IIa/b results disclosed last month and another phase II trial under way with its pain candidate, TRV130, Trevena Inc. priced a public offering for gross proceeds of about $45 million, selling about 11 million shares at $4 each in a deal expected to close Wednesday. Read More
Human antibodies produced by transchromosomal cows protected hamsters from hantavirus pulmonary syndrome, suggesting that passive vaccination could be a useful strategy against hantavirus. Read More
HONG KONG – China's government-founded Guangzhou Institutes of Biomedicine and Health (GIBH) has partnered with a U.S. biotech company to co-develop its cancer candidate. Read More
SHANGHAI – Canbridge Life Sciences Inc., a Beijing-based biopharma company started in 2012 with angel and private capital, has received $10 million in a series A investment from leading local health care venture capital funds Qiming Ventures and TF Capital. Read More
ANI Pharmaceuticals Inc., of Baudette, Minn., said it priced an underwritten public offering of $125 million aggregate principal amount of its 3 percent convertible senior notes due 2019. Read More
Juno Therapeutics Inc., of Seattle, signed an agreement to obtain a license from Opus Bio Inc., of Greenwich, Conn., for a CAR-T cell product candidate targeting CD22, a protein expressed on most B-cell leukemias and lymphomas. Read More
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said the FDA granted breakthrough therapy designation to oral proteasome inhibitor ixazomib (MLN9708) for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. Read More
strong>Cellular Biomedicine Group Inc., of Palo Alto, Calif., released 48-week follow-up data analysis of its phase I/IIa trial of Rejoin human adipose-derived mesenchymal progenitor cell (haMPC) regenerative therapy for knee osteoarthritis. Read More
Glaxosmithkline plc, of London, presented data at the British Thoracic Society meeting in London, from a systematic analysis of 25 randomized control studies, including a meta-analysis of three key efficacy outcomes, which explored the potential impact of the particle size of different inhaled corticosteroid-containing asthma medicines, including Seretide/Advair (salmeterol/fluticasone proprionate) on patient outcomes. Read More
The problem of cancer drug resistance gets the most attention for targeted agents. But tumors can also develop resistance to chemotherapy, with successive rounds of treatment leading to less and less of a response. Read More