Adlai Nortye Ltd., of Boston, of Hangzhou, China, said it opened its first U.S. site in Boston. It will serve as the target validation and translational medicine center focused on treatments for cancer, especially immuno-oncology. Read More
As part of a joint effort with the FDA to streamline regulatory oversight of gene therapy development, the NIH is proposing to end some of its activities that duplicate FDA requirements. "With the evolution of the field of gene therapy, duplication in reviews and paperwork have sometimes occurred without a commensurate increase in protecting participant safety," the NIH said. Read More
Titan Pharmaceuticals Inc., of South San Francisco, has filed to offer and sell class A units consisting of common stock and warrants and class B units consisting of series A convertible preferred stock and warrants. The offering has yet to be priced. Read More
HONG KONG – South Korea's Alteogen Inc.'s trastuzumab-based antibody-drug conjugate (ADC), ALT-P7, might face heavy competition in the breast cancer space, but the drug gained a potential leg up in gastric cancer, with the FDA awarding orphan designation. Read More
The human body is designed to rid itself of foreign materials. That makes medical implants, which often need to have a useful life in the body that's measured in decades, a pernicious challenge for industry. The business is littered with examples of implant or treatment device surfaces or coatings that have later proven to cause problems for patients. Read More
U.S. regulators cleared the first generic version of Epipen and Epipen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are anaphylactic, in adults and pediatric patients who weigh more than 33 pounds. Read More
It's an unexpected form of optimization for sure. But researchers at the University of Virginia have combined aspects of two antibodies that have failed in clinical trials to make a bispecific antibody that was able to shrink ovarian tumors in vivo. Read More
Fasinumab, the nerve growth factor (NGF) receptor antagonist that Regeneron Pharmaceuticals Inc. is advancing with partner Teva Pharmaceutical Industries Ltd., passed its efficacy test for the treatment of chronic pain from osteoarthritis (OA) of the knee and hip, based on findings from a substudy of a larger, long-term phase III study. However, two higher-dose regimens – 3 mg every four weeks and 6 mg every eight weeks – were discontinued earlier this year at the behest of an independent data monitoring committee. And the waiting continues for top-line safety data. Read More
Proposing a record $37.1 billion in funding for the NIH, the Health and Human Services (HHS) spending bill the Senate is prepping for a floor vote steers clear of the cost-savings measures President Donald Trump included in his fiscal 2019 NIH budget request. Read More
LONDON – mRNA specialist Biontech AG has added a further high value deal to its list of top tier corporate partnerships, signing a potential $425 million plus royalties collaboration agreement with Pfizer Inc. Read More
