Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company. Read More
The U.S. Senate voted 72-18 to confirm Stephen Hahn as the commissioner of the FDA, providing the agency with another commissioner with a deep background in oncology. Hahn succeeds Scott Gottlieb, who stepped down from the post in April and returned to the American Enterprise Institute. Read More
Neurotrauma Sciences LLC and Emory University’s Institute for Drug Development entered a license agreement for patents and technology invented at the school, enlarging a deal the two cut about a year ago. Read More
DUBLIN – Numab Therapeutics AG is banking an equity investment of CHF15 million (US$15.2 million) from its latest Asian partner, Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd., as part of a broad alliance to develop up to five multispecific antibodies from three programs based on Numab’s Match platform. Read More
BEIJING – Suzhou-based Alphamab Oncology Co. Ltd. (HK:9966), which aims to bring the first PD-L1/CTLA4 bispecific antibody to China, saw its share prices jump almost 30% on its debut on the Hong Kong Stock Exchange (HKEX) on Dec. 12, 2019, ending the year on a positive note for the pre-revenue biotech. Read More
HONG KONG – Singapore and U.S.-based Hummingbird Bioscience Pte Ltd. has raised $19 million in a series B financing round. Proceeds will be used to support the discovery of new disease targets and to fuel the work of co-discovery projects that are part of a multitarget collaboration agreement valued at more than $1 billion signed with Amgen Inc. in September. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
