The U.S. Supreme Court ruled Thursday that while U.S. federal courts "should accord respectful consideration to a foreign government's submission" when determining foreign law under the Federal Rule of Civil Procedure 44.1, they are "not bound to accord conclusive effect to the foreign government's statements." Read More
JHL Biotech Co. Ltd., of Hsinchu, Taiwan, raised $106 million in a convertible bond issuance, which closed May 15, the company said. Proceeds raised from the issue will be used for clinical trials, working capital needs and further development of the company's pipeline of biosimilar treatments. Read More
Insys Therapeutics Inc., of Phoenix, said preliminary results of a preclinical pharmacokinetics study of its investigational epinephrine nasal spray appeared to achieve bioavailability similar to that of intramuscular injection with Epipen 0.3 mg (epinephrine, Mylan NV). The study also demonstrated rapid drug absorption with the epinephrine nasal spray, the company said. Read More
HONG KONG – Chinese biotech firm Shanghai Henlius Biotech Inc. is taking its PD-L1 antibody known as HLX-20 to Australia to enter a phase I trial for the treatment of advanced solid tumors. The approval from the Australian authorities came six months after Henlius filed the investigational new drug (IND) application for HLX-20 to the China Drug Administration (CDA), and the trial will be the company's first in Australia. Read More
CoA Therapeutics represents the 19th subsidiary in three years for parent company Bridgebio Pharma Inc., adding a small-molecule approach to increase levels of coenzyme-A, or CoA – thus, the startup's intuitive name – in genetic disorders associated with CoA deficiency. Through its model of housing each therapeutic effort in an individual subsidiary supported by shared central resources, Bridgebio committed funds to drive CoA's lead program through human proof of concept. Read More
New York-based Medidata Solutions Inc. has acquired Shyft Analytics Inc., of Waltham, Mass., for $195 million in an effort to build applications and analytics that are supported by the largest available pool of life sciences research data. The combined company brings together the clinical development data capabilities that are core to Medidata with Shyft's commercial and real-world data analytics. Read More
Mutations in the adenine nucleotide translocase type 1 (ANT1) gene may confer a risk for bipolar disorder through a complex interaction between serotonin and mitochondrial signaling within the brain, a new Japanese study suggests. Read More
DUBLIN – Syncona Ltd., the listed London-based biotech investment firm, is doubling down on gene therapy by investing $35 million in two new ventures, Swanbio Therapeutics Ltd., a Boston-based startup focused on central nervous system conditions, and Orbit Biomedical Ltd., a London-based firm developing a cannula device to enhance surgical delivery of gene therapy vectors to the back of the eye. Read More
Hoping to stop the shenanigans of drug companies that game the system to keep the U.S. market to themselves, the Senate Judiciary Committee voted 16-5 Thursday to send the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Read More
