Less than a year after licensing constipation drug elobixibat from Swedish biotech Albireo AB, Ferring Pharmaceuticals SA initiated enrollment in two Phase III trials of the investigational compound in chronic idiopathic constipation (CIC).
Armed with a novel technology and a new target – a class of disease modifying therapies that preserve intracellular S-nitrosoglutathione (GSNO), a regulator of organ repair, regeneration and healing – N30 Pharmaceuticals Inc. has quietly evolved from a 2007 start-up into a development-stage biotech with 30 employees.
Less than a year after licensing constipation drug elobixibat from Swedish biotech Albireo AB, Ferring Pharmaceuticals SA initiated enrollment in two Phase III trials of the investigational compound in chronic idiopathic constipation (CIC).
Titan Pharmaceuticals Inc. expressed surprise and disappointment after receiving a complete response letter (CRL) late Tuesday from the FDA for investigational drug Probuphine, a subdermal implant designed for the maintenance treatment of opioid dependence in adults. The reaction may have been warranted, however. At first blush, the CRL appeared to have all the trappings of an ambush.
The FDA put some lift under the wings of Raptor Pharmaceutical Corp., approving the orphan drug Procysbi (RP103, cysteamine bitartrate delayed-release) on its PDUFA date in the initial indication of nephropathic cystinosis (NC).
CHICAGO – For Avaxia Biologics Inc., the decision to attend BIO 2013 was a no-brainer. The Lexington, Mass.-based company is in the middle of a Phase Ib study of lead compound AVX-470, an orally administered anti-TNF polyclonal antibody, in ulcerative colitis (UC).
CHICAGO – This could be a very good year for deals, according to data from the Biotechnology Industry Organization (BIO) and biopharma consulting firm Campbell Alliance Group that were presented during a super session on structuring pipeline deals.
CHICAGO – Innovation was the topic of a heavily attended supersession at BIO 2013 that featured presenters from big pharma, academia, federal agencies and the venture capital (VC) community but, interestingly, no biotechs.
ActoGeniX NV closed a Series B equity financing round, raising €€10.7 million (US$14 million) to move its ActoBiotics program to the investigational new drug application (IND) stage in a second indication of inflammatory bowel disease (IBD).
CHICAGO – Small biotechs, already smarting from the stingy venture capital (VC) market and cutbacks in government funding, are looking nervously over their shoulder at the increasingly cozy relationship between big pharmas and academic institutions. And well they should.