The approval of anti-cholesterol therapy Praluent (alirocumab) from Regeneron Pharmaceuticals Inc. and Sanofi SA heralds a change "equivalent to the statin revolution in terms of lipid management," Katherine Wilemon, founder of the Familial Hypercholesterolemia (FH) Foundation, told BioWorld Today. Read More
Messy. Lackluster. Weak. Those descriptions are rarely ascribed to earnings from Biogen Inc., but shares (NASDAQ:BIIB) of the Cambridge, Mass.-based company took a humbling blow after analysts hurled those adjectives, and more, at the company's second quarter report. Read More
LONDON – After 30 years in development, an investment of $565 million and phase III studies involving 16,000 subjects, the first vaccine against malaria has received a positive opinion from the EMA. Read More
With the FDA telling Sunesis Pharmaceuticals Inc. it wants additional clinical evidence on the experimental acute myeloid leukemia (AML) drug Qinprezo (vosaroxin) before backing submission of a new drug application (NDA), the company said it will "evaluate and refine" its U.S. plans while pursuing marketing approval for the drug in Europe, where regulators appear receptive to moving ahead with existing data. Read More
HONG KONG – Newly listed Chinese biopharmaceutical company Shenyang-based 3SBio Inc. acquired small-molecule maker Zhejiang Wansheng Pharmaceutical Co. Ltd. for ¥528 million (US$85 million) to complement its oncology and nephrology pipeline. Read More
By following up a serendipitous discovery with detailed sequencing, scientists have been able to gain new insights into both a rare genetic disease, and a common immune system protein. Read More
Exelixis Inc., of South San Francisco, said it priced a public offering of 25 million shares at $5.40 apiece for gross proceeds of about $135 million. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported total revenues of $123.9 million for the second quarter, with the increase over last year primarily related to the addition of Makena (hydroxyprogesterone caproate injection), a drug approved for pre-term birth, in November 2014, which contributed $63.6 million in net product sales in the second quarter, and the recognition of $39.2 million of collaboration revenue related to the termination of the company's ex-U.S. marketing agreement for iron deficiency anemia drug Feraheme (ferumoxytol). Read More
Evotec AG, of Hamburg, Germany, became part of a research initiative between a newly established for-profit company of the Gladstone Institutes called Cure Network Ventures Inc. and Dolby Family Ventures. Read More
AB Science SA, of Paris, reported the successful completion of a futility analysis related to the masitinib phase III trial for the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis. Read More
Researchers from Harvard University have shown that antibiotic resistance can make bacteria more rather than less able to divide, a finding that is contrary to the longstanding belief that antibiotic resistance imposes a fitness cost on the resistant organisms. Read More
