Patience paid off for Emergent BioSolutions Inc., which scored a big win on Monday by landing an award with the U.S. Centers for Disease Control and Prevention potentially worth $1.25 billion to supply the U.S. government with 44.75 million doses of BioThrax (anthrax vaccine adsorbed) over a five-year period.
Three biotechs and a U.S. university will share $39.6 million in new funding from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to progress drugs designed to treat injuries associated with acute radiation syndrome (ARS).
After a long and winding road that included two Phase III detours, Chelsea Therapeutics International Ltd. moved forward with a new drug application (NDA) for its lead candidate Northera (droxidopa), an orally active synthetic precursor of norepinephrine, to treat symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and nondiabetic autonomic neuropathy.
Ambrx Inc. became the latest jewel in the string of pearls that Bristol-Myers Squibb Co. is assembling, landing a deal worth $24 million up front for pegylated versions of the fibroblast growth factor 21 (FGF-21) protein and the relaxin hormone.
Following a meeting with officials in the FDA's Office of New Drugs, Orexigen Therapeutics Inc. has received the green light to resolve its complete response letter for Contrave (naltrexone HCI/bupropion HCI) and resubmit the new drug application.
The second pivotal Phase III trial (Study 103) of the HIV Quad regimen (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) under development by Gilead Sciences Inc. met the expectations of the company and most analysts by demonstrating noninferiority – though not superiority – at week 48 compared to ritonavir-boosted atazanavir plus Truvada (emtricitabine/tenofovir disoproxil fumarate). (BioWorld Today)
Kythera Biopharmaceuticals Inc. closed a Series D financing, landing $37.4 million to launch U.S. Phase III trials for its lead product, ATX 101. The first-in-class injectable is designed to reduce small fat deposits – including those under the chin and jawline, known as submental fat.
Soligenix Inc. (formerly DOR BioPharma Inc.) halted its confirmatory Phase III trial of orBec (oral beclomethasone dipropionate, or OBD) for acute gastrointestinal graft-vs.-host disease (GvHD) following stem cell transplant after an interim analysis by an independent data safety monitoring board concluded the study was "highly unlikely" to meet its predetermined efficacy endpoint. No safety concerns were raised.
Privately held SARcode Bioscience Inc. has enrolled the first patient in OPUS-1, its pivotal Phase III trial of topical SAR 1118 ophthalmic solution. OPUS-1 will study the safety and efficacy of SAR 1118 in the treatment of dry eye.