Evoke Pharma Inc., of Solana Beach, Calif., said it reached an agreement with Spaulding Clinical Research for its planned comparative exposure pharmacokinetic (PK) study for lead candidate Gimoti, a nasal delivery formulation of metoclopramide for symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Read More
Cellular Dynamics International Inc. (CDI), of Madison, Wis., signed a distribution agreement with Stemcell Technologies Inc., of Vancouver, British Columbia. Under the terms of the agreement, Stemcell will distribute CDI's iCell catalog of products in North America, Europe and Singapore, with other countries under consideration. Read More
Diamedica Therapeutics Inc., of Minneapolis, said it completed a nonbrokered private placement with an undisclosed U.S. investor, issuing about 10.5 million units at 19 cents each, with each unit consisting of one common share and half of one common share purchase warrant. Gross proceeds totaled about $2 million and will be used to advance the firm's R&D program, including DM199 for the treatment of neurological and kidney diseases, and for general corporate purposes. Read More
HONG KONG – In a nationwide effort to combat clinical trial data fabrication, China's Supreme People's Court and the CFDA have simultaneously proposed new actions and regulatory changes. Read More
Prometic Life Sciences Inc.'s president and CEO, Pierre Laurin, told BioWorld Today that "anything can happen here," as the company pursues work with the oral antifibrotic PBI-4050, but for now the FDA has agreed on the design of the first of the Laval, Quebec-based firm's pair of planned phase II/III trials in idiopathic pulmonary fibrosis (IPF). Read More
LONDON – Circassia Pharmaceuticals plc is ditching the allergy vaccines technology around which it was founded after a phase IIb field study failed to find a significant effect vs. placebo in reducing symptoms of house dust mite allergy. Read More
LONDON - Two years after grossing $210 million in an upsized IPO on Nasdaq, Galapagos NV has gone back to the market and raised $338 million in a placing. Read More
DUBLIN – Motif Bio plc is on course for an NDA filing next year for its diaminopyrimidine antibiotic, iclaprim, following a positive readout from the first of two phase III trials in patients with acute bacterial skin and skin structure infection (ABSSSI), in which it demonstrated noninferiority to vancomycin. Results from a second study, which is following the same protocol, are due in the second half of this year. Read More
