Welcome to this week's FiercePharmaAsia report, which includes stories on Big Pharma's expansion in the region, a U.S. regulatory warning for a South Korean drugmaker, new results in Takeda and Myovant’s trial for relugolix to treat uterine fibroids and more.
AbbVie completed another phase of its Singapore manufacturing expansion by opening a new biologics unit that complements existing small molecule API production at the plant. The expansion of the facility in the Tuas Biomedical Park in Singapore is part of the company’s $320 million investment in the facility. The Chicago-based company announced in 2014 that it planned to build a 1.2 million-square-foot facility, but soon after bought a decommissioned contained API manufacturing plant that was already built, along with some additional buildings and extra equipment.
A body of evidence is building behind Takeda and Myovant’s hormonal therapy in uterine fibroids, with late-stage Japanese data reinforcing positive phase 2 results with the drug in the U.S. The latest phase 3 trial showed that the oral drug matched older uterine fibroid treatment leuprorelin acetate—which is given by a monthly injection—in alleviating symptoms. The 24-week trial enrolled 280 Japanese women with symptomatic uterine fibroids, benign tumors that originate in the uterus and can cause excessive menstrual bleeding and pain.
South Korean drugmaker Dasan E&T was slapped with a warning letter from the FDA based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant. The agency said Dasan failed to adequately test raw materials and finished products to verify they conformed to appropriate specifications.
Japan's Takeda will make another investment in its production operations in the European Union. The company will invest up to €100 million in a new manufacturing plant at its site in Clondalkin near Dublin, Ireland, that could eventually add 100 jobs to its operations there, The Times reported. The outlay is for a 3,000-square-meter, (32,292-square-foot) two-story manufacturing plant next to an existing facility at the Grange Castle business park, the newspaper said.
GlaxoSmithKline, which has worked hard to put 2013’s China bribery scandal behind it, got an assist from a U.S. judge in that department. U.S. District Judge Nitza Quiñones Alejandro in Philadelphia tossed out a lawsuit from a husband-and-wife team of former private eyes, Reuters reports. Peter Humphrey, of the U.K., and Yu Yingzeng, of the U.S., claimed the British pharma giant had misled them into probing a whistleblower in China, an investigation that led to their arrest.