Reata Pharmaceuticals Inc.’s hopes, as well as those of many people living with Alport syndrome, were dashed Dec. 8 when the FDA’s 13-member Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the available evidence doesn’t show that the benefits of bardoxolone methyl outweighed its risks in treating the rare genetic condition. Read More
Daré Bioscience Inc.’s investors will have to wait a while for details regarding a commercialization partnership centered on Xaciato (2% clindamycin phosphate gel, formerly known as DARE-BV1) as a single-dose treatment of bacterial vaginosis (BV) in females 12 years of age and older. Approved Dec. 7, Xaciato is expected to launch next year. Read More
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site. Read More
LONDON – Merck KGaA has increased the size of its corporate venture fund M Ventures to €600 million (US$676.4 million), to be invested over the next five years. This is the third increase in the financial commitment to the evergreen fund following its formation as Merck Serono Ventures in 2009, with €40 million. Since then, it has backed more than 80 companies. The larger fund will allow M Ventures to further grow the number and the size of its investments but, said Hakan Goker, managing director of M Ventures, “We will not change the strategy per se.” Read More
Newpath Partners closed its second fund with a $350 million raise, to continue its model of backing scientist-entrepreneurs during the earliest stages of company formation. The Boston-based firm works closely with a tight circle of influential scientific leaders to establish firms with high levels of scientific originality – and high ambitions to match. Read More
It’s been more than six years since the FDA’s first approval of an oncolytic virus – Amgen Inc.’s melanoma drug Imlygic (talimogene laherparepvec) – and it’s easy to argue that progress in the field has been overshadowed by success with other immunotherapy types such as checkpoint inhibitors. Though the FDA hasn’t approved any more oncolytic viruses since then, Phoenix-based Oncomyx Therapeutics Inc. is one of several companies trying to change that. Read More
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial. Read More
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer. Read More
New hires and promotions in the biopharma industry, including: Adial, Cellarity, Ikena, Lyndra, Mission, Ocuphire, Oramed, Rocket, Tessera, Zylorion. Read More
