In terms of biomedical research progress, 2018 was a quieter year than some of its predecessors. The biggest news of the year may lie in changes in the way research – a deeply human endeavor – is conducted, setting the stage for the breakthroughs of tomorrow. Read More
Researchers from The Jackson Laboratory have developed Alzheimer's disease (AD) model mice that were identical in the known AD risk gene they carried, but differed in the rest of their genome. The team hopes to use the animals to understand genetic factors that interact with known familial risk genes. Read More
Polarityte Inc., of Salt Lake City, said it registered Osteote with the FDA, pursuant to applicable regulations governing human cells, tissues and cellular and tissue-based products. Osteote is an autologous and homologous product intended to repair, reconstruct, replace and supplement many types of bones using a small sample from the patient. Read More
Harpoon Therapeutics Inc., of South San Francisco, filed a registration statement with the SEC for a proposed IPO aiming to raise $86 million, though the number of shares and share price have not yet been disclosed. Read More
Medical device startups are becoming increasingly ambitious when it comes to treating diseases that are ill-served by drugs. The latest on this front is Enclear Therapies Inc., a Cambridge, Mass.-based company that is developing a device to clear toxic proteins from cerebrospinal fluid (CSF) to treat diseases such as amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP) and other neurological diseases. Read More
HONG KONG – With Thursday's nod for Tyvyt (sintilimab injection), a core asset of HKEX-listed Innovent Biologics Inc. to treat classical Hodgkin lymphoma, either relapsed or refractory after two or more lines of systemic chemotherapy, Chinese regulators have approved two homegrown anti-PD-1 monoclonal antibodies in little more than a week. Read More
Just before the holiday break, the FDA put an exclamation point on the number of new molecular entity (NMEs) approvals this year with two more medicines crossing the goal line. At the end of November, the count had ticked to 54 following the green light for Coral Gables, Fla.-based Catalyst Pharmaceuticals Inc.'s Firdapse (amifampridine phosphate), the first drug designated in the U.S. to treat adults with Lambert-Eaton myasthenic syndrome. (See BioWorld, Nov. 30, 2018.) Read More
It was a dramatic week on Wall Street spanning the Christmas holidays, with the Dow Jones Industrial Average plunging dramatically and then recovering to post a record climb of more than 1,000 points in one day. Not surprisingly, biopharma company equities were taken for a wild ride during the dramatic drop and subsequent recovery in the general markets. Read More
