Biotron Ltd., of Sydney, Australia, initiated a randomized, double-blind, placebo-controlled, multicenter phase II trial (BIT225-009) with lead antiviral drug, BIT225, together with the combination antiretroviral therapy Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences Inc.), in treatment-naïve patients with HIV-1 infection. Read More
Mateon Therapeutics Inc., of South San Francisco, said it was encouraged by preliminary data from four different syngeneic mouse models studying the company's lead investigational drug CA4P when combined with checkpoint inhibitors. Read More
Aeterna Zentaris Inc. completed a full review of data from its confirmatory phase III trial of oral Macrilen (macimorelin) for use as a growth hormone stimulation test to assess growth hormone deficiency in adults (AGHD) and concluded the data were sufficient to make a second run at registration with the FDA. In 2014, the agency issued a complete response letter (CRL) on the new drug application. Read More
Zosano Pharma Corp.'s migraine-targeting zolmitriptan-coated microneedle patch, M207, met both co-primary endpoints of the company's pivotal phase III Zotrip trial, delivering freedom from pain at two hours for 41.5 percent of treated patients and relieving the most bothersome symptom for a majority of those treated at the same time point. Read More
NEW YORK – The 21st Century Cures Act signed into U.S. law last year included a provision for $500 million in funding for prevention and treatment programs targeting the opioid epidemic. Read More
KARACHI, Pakistan – Facing a chronic shortage of regulations, the biopharmaceutical industry in Pakistan is struggling to get traction despite widespread need and huge market potential. With a population that is rapidly approaching 200 million, Pakistan's pharmaceutical sector sees high growth potential, but it's held back by a lack of regulations that often translates into chronic shortages of essential medicines. Read More
PERTH, Australia – After announcing its plans for an IPO on Nasdaq, Aussie biotech Immuron Ltd. said it is ramping up its phase II program for its immunotherapy IMM-124E in non-alcoholic steatohepatitis (NASH). Read More