Perhaps expectations were overly optimistic, or more likely the road forward for emricasan may be significantly more arduous than Conatus Pharmaceuticals Inc. originally envisioned.
Disclosure of top-line data on Biogen Idec Inc.'s anti-LINGO-1 monoclonal antibody (MAb), BIIB033, in acute optic neuritis (AON) so captivated the analyst community that they might have been mistaken for scrutinizing a grand slam emerging from a pivotal trial.
Little more than six months after opening at $20 after pricing its initial public offering, Zafgen Inc. impressed investors by reporting that beloranib, its methionine aminopeptidase 2a (MetAP2) inhibitor, met the primary efficacy endpoint of weight reduction in a small phase II trial in patients with hypothalamic injury associated obesity, or HIAO.
Alizé Pharma SAS has a diverse and seemingly incongruous portfolio that includes an unacylated ghrelin analog (UAG) aimed at Prader-Willi syndrome and type 2 diabetes, a pegylated recombinant L-asparaginase to treat acute lymphoblastic leukemia (ALL) and a rare disease program with an as-yet undisclosed target. But that doesn’t mean the programs compete with each other.
How much time do you spend with old people? That’s a loaded question, of course. Age is a relative term, since we age every day and so does the world’s population. Even though the global median age was estimated at a mere 29 years in 2010, the number of people 65 and older is projected to triple by mid-century, from 531 million in 2010 to 1.5 billion in 2050, according to the Pew Research Center. In the U.S., the population of seniors is expected to more than double, from 41 million to 86 million. Still, I spend a lot of time...
With the PDUFA date for Cubist Pharmaceuticals Inc.'s potential blockbuster ceftolozane/tazobactam, branded Zerbaxa, just two weeks away, the Lexington, Mass.-based company became the latest target in a hot round of biopharma dealmaking.
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.
Through the first week of December, 14 drugs came to market this year with orphan status in the country of their initial launch. The list included Jakafi (ruxolitinib), from Incyte Corp., of Wilmington, Del., which last week became the first drug approved by the FDA in the orphan indication polycythemia vera, a chronic type of bone marrow disease.
The FDA Wednesday afternoon granted accelerated approval with breakneck speed – more than five months ahead of its May 19, 2015, PDUFA date – to Amgen Inc.'s blinatumomab to treat patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, or B-cell ALL, a rare form of ALL.
Efforts to plumb the human microbiome propelled yet another biotech to a fat financing. Seres Health Inc. closed a hefty series C, raising $48 million to advance its Ecobiotic therapeutics, designed to treat disease by restoring the function of a dysbiotic microbiome.
