Scientists from the Massachusetts Institute of Technology have reported they were able to transplant pancreatic islet cells into immunocompetent mice that were able to control blood sugar levels for nearly half a year. Read More
Akari Therapeutics plc, of London, said the U.K. Medicines & Healthcare products Regulatory Agency cleared the firm to conduct a phase Ib multiple ascending-dose trial testing Coversin, a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9. Read More
Les Laboratoires Servier SAS, of Neuilly-sur-Seine, France, said its Canadian unit reported Health Canada approval of Viacoram (perindopril arginine/amlodipine besylate) as a first-line treatment for mild to moderate hypertension. Read More
Novavax Inc., of Gaithersburg, Md., said it closed its $300 million convertible senior unsecured note offering. Under the purchase agreement, the initial purchasers may exercise their option to purchase up to an additional $30 million aggregate principal amount of the notes solely to cover overallotments any time before Feb. 24. Read More
HONG KONG – With the successful completion of a phase II study in the U.S. for its flagship product, VM202, for the treatment of critical limb ischemia (CLI), South Korean biopharma Viromed Co. Ltd. is off to a good start this year. Read More
The success of antiretroviral therapy (ART) is a modern miracle, turning HIV – for those who have access to treatment, at least – from a death sentence into a chronic illness. Read More
DUBLIN – Inflarx GmbH hit the primary endpoint of a phase IIa trial of its first-in-class complement 5a-targeting antibody, IFX-1, in a trial of 72 intensive care unit (ICU) patients with early stage sepsis-associated organ dysfunction. Read More
SHANGHAI – Suzhou, China-based Adagene Inc. received $28 million in series B financing to further enhance its technology-driven antibody discovery platform and nudge its own portfolio of innovative antibodies, against targets related to cancer and other diseases, closer to the clinic. Read More
LONDON – Actelion Ltd. added a positive EMA opinion to the FDA and Health Canada approvals for its first-in-class, selective prostacyclin IP receptor agonist, Uptravi (selexipag), for treating pulmonary arterial hypertension (PAH). Read More
Amgen Inc.'s investor-pleasing fourth quarter and full 2015 earnings won the customary nods from analysts, who promptly zeroed in on the next major milestone – phase III data in osteoporosis with romosozumab in postmenopausal women, and how those "romo" results might stack up against the bone drug abaloparatide from Radius Health Inc., which has already made a strong phase III showing against Forteo (teriparatide, Eli Lilly and Co.) in the trial called ACTIVE. Read More
FDA approval for Merck & Co. Inc.'s once-daily hepatitis C virus (HCV) treatment, Zepatier (elbasvir and grazoprevir), is expected to bring new, but not disruptive, competition to the hot market currently dominated by Gilead Sciences Inc. Zepatier, projected by consensus forecasts to generate $544 million for Merck this year and more than twice that by 2018, according to Thomson Reuters Cortellis, offers a new oral treatment option for patients with genotype 1 and 4 infections (GT1 and GT4). Read More