Molecular Templates Inc., of Austin, Texas, has signed an R&D collaboration with Bristol Myers Squibb Co. (BMS) worth $70 million up front and potential development, regulatory and sales milestone payments of up to $1.3 billion. Molecular Templates will work on therapies designed for unnamed oncology targets to kill targeted cells by forcing receptor internalization, delivering payloads and enzymatically inactivating ribosomes.
HONG KONG – Ono Pharmaceutical Co. Ltd. has agreed to pay Ribon Therapeutics Inc. as much as ¥15.4 billion (US$147.3 million) for exclusive rights to develop and commercialize the company’s phase I PARP7 inhibitor RBN-2397 for the treatment of solid tumors in Japan, South Korea, Taiwan and ASEAN countries.
While it’s too late to save the contingent value rights connected with the acquisition of Celgene Inc., Bristol Myers Squibb Co.’s CD19-targeted CAR T therapy, lisocabtagene maraleucel, for treating certain types of relapsed or refractory large B-cell lymphoma patients who have received at least two prior therapies, won FDA approval.
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases.
And just like that, it’s over. Bristol Myers Squibb Co. on Jan. 1 confirmed what many suspected, that FDA approval for lisocabtagene maraleucel (liso-cel) did not happen by the Dec. 31 deadline, thereby automatically terminating the contingent value rights (CVR) agreement issued as part of its acquisition of Celgene Inc.
PERTH, Australia – Although Australians pay less for their drugs than patients in many other countries, Australia is falling behind when it comes to reimbursement for newer, targeted therapies, according to a report launched by Medicines Australia that assessed the timelines for registration and reimbursement of new medicines in Australia compared to 10 other Organisation for Economic Co-operation and Development (OECD) countries.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
HONG KONG – Peptidream Inc. has partnered with four other Japanese companies to research and develop peptide therapeutics capable of neutralizing the SARS-CoV-2 virus as well as potential future coronavirus outbreaks. Peptiaid Inc., the joint venture established with Fujitsu Ltd., Mizuho Financial Group Inc. subsidiary Mizuho Capital Co. Ltd., Takenaka Corp. and Kishida Chemical Co. Ltd., will have capital totaling ¥599 million (US$5.73 million) by Dec. 31.