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. Read More
Backers in Tango Therapeutics Inc.’s $60 million series B round represent “a group of really smart crossovers who normally don’t come in quite this early” and “hung in there” during some especially hard times on Wall Street recently, CEO Barbara Weber told BioWorld. “We were about to sign the term sheet the first time the market crashed, which was a little nerve-wracking.” Read More
Specific therapies against a new disease take time to develop. But there are methods that can speed up that development – and in the meantime, there are ways to make do with what’s already in the cupboard. Read More
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection. Read More
HONG KONG – China and U.S.-based Zai Lab Ltd. has signed on to develop and commercialize REGN-1979, a CD20xCD3 bispecific antibody from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Read More
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. reported interim data showing that lead candidate paxalisib (formerly GDC-0084) saw a positive overall survival signal in its phase II glioblastoma trial, and the company raised AU$7.2 million (US$4.4 million) days after the data were released. Read More
One simple four-letter word can make a world of difference in how quickly biosimilars and interchangeables bring full competition to the U.S. marketplace of biologics, a handful of companies and industry groups told the FDA in comments on a draft guidance concerning the labeling of follow-ons that are licensed for fewer indications than the reference biologic. Read More
I2O Therapeutics Inc., of Allston, Mass., raised $4 million in seed funding to further its work on oral formulations of therapies typically limited to injections, such as biologics, large molecules and peptide-based pharmaceuticals. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aridis, Bridge, Firstwave, Fujifilm, Kezar, Laurent, Mesoblast, Neoimmunetech, Otonomy, Sirnaomics, Tenax, Vigeo, Zelira. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athenex, Biohaven, Calcimedica, EMD Serono, Kiadis, Lannett, Pfizer, Viracta. Read More
