Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
Less than a year after backing Tscan Therapeutics Inc.'s $48 million series B round, Novartis AG is tapping the Waltham, Mass.-based company to discover and develop new T-cell receptor (TCR)-engineered T-cell therapies for up to three new solid tumor targets. The collaboration includes an up-front technology access fee and research funding totaling $30 million, as well as potential clinical, regulatory and sales-based milestone payments that could total hundreds of millions of dollars, Tscan said.
Following a priority review, partners Astrazeneca plc and Merck & Co. Inc. have gained a green light from the FDA for U.S. marketing of the oral MEK1/2 inhibitor Koselugo (selumetinib), the first FDA-approved treatment for the rare genetic disorder neurofibromatosis type 1 (NF1).
A little more than eight months after Pfizer Inc.'s $11.2 billion acquisition of Array Biopharma Inc., a combination of Array-developed Braftovi (encorafenib) and cetuximab has won FDA approval for the second-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC), becoming the first approved therapy specifically targeting that mutation.
Novavax Inc., one of the first biopharma companies to reveal its efforts to develop a SARS-CoV-2 vaccine in January, has identified a prefusion protein for testing in an Australian phase I trial, slated to start in mid-May.
Pluristem Therapeutics Inc., an Israeli regenerative medicine company, said several of the seven COVID-19 patients treated with its allogeneic placental expanded (PLX) cells have progressed from suffering severe symptoms of the disease to signs of clinical recovery, including respiratory improvements.
Shares of Millendo Therapeutics Inc. (NASDAQ:MLND) fell 70.1% to $1.45 on April 6 after a pivotal study of its experimental Prader-Willi syndrome (PWS) therapy, livoletide, failed to show a statistically significant improvement in hyperphagia, or insatiable hunger, and food-related behaviors vs. placebo.
Against a backdrop of nearly 15 global biopharma IPOs on deck on a day when all major U.S. market indices fell, shares of cancer drug developer Zentalis Pharmaceuticals Inc. (NASDAQ:ZNTL) shot up 29% to $23.20 on April 3 after an upsized initial filing to sell 9.2 million shares at a top-of-range $18 each.
