The FDA released a draft guidance on developing antiviral drugs for prophylaxis and treatment of respiratory syncytial virus (RSV) infection. The draft discusses nonclinical development, early phases of clinical development and phase III trial designs.
Vidac Pharma Ltd., of Jerusalem, reported data from a phase IIa trial testing VDA-1102 in patients with actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma.
American Gene Technologies International Inc., of Rockville, Md., presented its approach for developing a functional cure for HIV infection at the Cell & Gene Meeting on the Mesa in La Jolla, Calif.
Immunogen Inc., of Waltham, Mass., closed its public offering of about 16.7 million shares, including 2.2 million shares sold to cover the underwriters’ full overallotment option, priced at $6.50 per share.
HONG KONG – YL Biologics Ltd. has inked a licensing deal to distribute a biosimilar for the treatment of anemia by Korea’s CJ Healthcare Ltd. in Japan. The drug, CJ-40001, is CJ Healthcare’s version of Amgen Inc.’s Aranesp (darbepoetin alfa).
"What we've accomplished from then to now is what we dreamt of," Ardelyx Inc. CEO Mike Raab told BioWorld, referring to stellar phase III data with Na-hydrogen exchanger 3 (NHE3) transporter blocker tenapanor in irritable bowel syndrome (IBS-C), unveiled less than a week before the 10-year anniversary of the firm's founding. "Companies like ours don't get the attention at times from the world out there," he said, because they lack headline-grabbing approaches such as immuno-oncology and often face "a tougher, more extensive path to success."
Rhythm Pharmaceuticals Inc., of Boston, closed its IPO of about 8.1 million shares of common stock at $17 each, which includes the exercise in full by the underwriters of their option to purchase up to about 1 million shares of common stock.
Synaffix BV, of Amsterdam, said ADC Therapeutics Sarl, of Lausanne, Switzerland, has triggered a second target-specific license under their commercial license Agreement dated October 2016, to develop an antibody-drug conjugate (ADC) using Synaffix's site-specific ADC technology.
Critical Outcome Technologies Inc., of London, Ontario, said the first patient was dosed in the head and neck squamous cell carcinoma (HNSCC) arm of its phase I trial of COTI-2 at a dosage level of 1 mg/kg.
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