News of at least a three quarter delay in seeking regulatory approval for Fabry disease candidate migalastat unsurprisingly sent shares of Amicus Therapeutics Inc. falling 24 percent in Monday morning trading, but reports of the firm's recent meeting with the FDA left room for optimism for the Glaxosmithkline plc-partnered molecular chaperone.
On Thursday, Cempra Inc. disclosed a successful end-of-Phase II meeting with the FDA, citing only the need for additional funding to proceed with the planned Phase III trial testing intravenous (I.V.)-to-oral administration of macrolide antibiotic solithromycin in community-acquired bacterial pneumonia (CABP).
Atlanta's Emory University launched a new initiative to help bridge the ever-widening gap between the laboratory discoveries that trumpet the possibility of breakthrough medical treatments and the proof-of-concept data that are needed to entice significant industry investment – known as the dreaded "Valley of Death" in the landscape of drug discovery.
Hopes for a resubmitted Heplisav application by the end of this year were dashed Monday, after Dynavax Technologies Corp. said a recent meeting with the FDA indicated that an additional safety study would be required before the agency would consider approving the hepatitis B vaccine.
With data from the first clinical trial of anti-TNF polyclonal antibody AVX-470 in ulcerative colitis (UC) due toward the end of this year, Avaxia Biologics Inc. shored up its balance sheet with an additional $5 million, bringing its total Series B funding to $11.4 million.
Second Genome Inc. brought on board its first big pharma partner, signing Janssen Biotech Inc. to a multiyear deal focused on using the San Bruno, Calif.-based biotech's microbiome modulation platform to discover drugs for ulcerative colitis.
Much-awaited data from Synta Pharmaceuticals Corp.'s mid-stage GALAXY-1 study left investors less than satisfied, as shares of the Lexington, Mass.-based biotech dropped 34 percent.
While last year's American Society of Clinical Oncology (ASCO) meeting ended on cautiously encouraging advances in the cancer immunotherapy space, this year's meeting has put immunotherapy front and center, thanks in part to much-awaited data on and anti-PDL-1 and anti-PD-1 drugs from Roche AG and Bristol-Myers Squibb Co., respectively. (See BioWorld Today, June 6, 2012.)
London-based GlaxoSmithKline plc snagged a next-generation T-cell vaccine platform and several promising early stage candidates in its buyout of Swiss firm Okairos AG for €250 million (US$323.8 million).
Salix Pharmaceuticals Ltd. said its two pivotal studies of budesonide foam in active to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS) hit the primary endpoints, with a statistically significant number of patients in the treatment arm achieving clinical remission vs. placebo.
