The FDA released briefing documents related to Tuesday's meeting of the Antimicrobial Drugs Advisory Committee, which will take up the NDA for tecovirimat, sponsored by Siga Technologies Inc., of New York, for the treatment of smallpox disease caused by variola virus in adults and pediatric patients. Read More
Dispersol Technologies LLC, of Georgetown, Texas, said it secured commitments for $27 million in equity financing that will enable the continued development of its portfolio of bioavailability enhanced 505(b)(2) drug products. Read More
Seattle Genetics Inc., of Bothell, Wash., reported strong sales of Adcetris (brentuximab vedotin), tallying $95.4 million in the first quarter, 36 percent higher than the previous year's period, an amount that surpassed consensus estimates of $88.9 million. Read More
Invitae Corp., of San Francisco, is launching a new program called SMA Identified with Cambridge, Mass.-based Biogen Inc. to offer free genetic testing to patients suspected of having or clinically diagnosed with spinal muscular atrophy (SMA). Biogen, which sells SMA treatment Spinraza (nusinersen), is supporting the program financially, but won't receive patient information. Read More
A liquid biopsy assay that incorporates multiple companion diagnostics has gotten a boost from the FDA. Cambridge, Mass.-based Foundation Medicine Inc. reported that the agency had granted a breakthrough device designation for an expanded version of its FoundationACT (Assay for Circulating Tumor DNA) assay, which would include more than 70 genes and genomic biomarkers for microsatellite instability and blood tumor mutational burden. Read More
HONG KONG – An artificial compound derived from vitamin A, acyclic retinoid (ACR), has been shown to selectively target cancer stem cells (CSCs) and reduce the post-therapeutic recurrence of hepatocellular carcinoma (HCC) in a new study and is currently in phase III trials for that indication in Asia. Read More
HONG KONG – Sino-American biopharma company CBT Pharmaceuticals Inc. is set to work with South Korea's Crystalgenomics Inc. on an investigational combination therapy for solid tumors. The two agreed to co-develop and commercialize the final product worldwide. Read More
Accelerator Life Science Partners has another startup under its wings, but the process to launch Proniras Corp. wasn't exactly your typical newco formation. Read More
DUBLIN – Polyphor AG is seeking up to CHF140 million (US$141.4 million) in Switzerland's first biotech IPO since November 2014. The IPO comprises a base offering of shares that would bring in CHF100 million plus an "upsize option" that would add CHF40 million more. An overallotment option, if exercised, would add another CHF10 million to the proceeds. Read More
TG Therapeutics Inc. CEO Michael Weiss said he expects the firm's anti-CD20 therapy for multiple sclerosis (MS) will become available "at the right time with the right message, with convenience and price" at the forefront of patients' minds. "They're angry about the pricing. Drugs that cost them, less than 10 years ago, $10,000 to $15,000 a year are now $80,000 a year. And they just can't understand why." Read More
Preterm birth is the root cause of roughly a third of deaths in the first year of life in the developed world. Researchers from the University of California at San Francisco have shown fetal immune reactions to maternal proteins during pregnancy. Previous work has shown that maternal immune responses to the fetus contributed to pregnancy complications, but the reverse possibility has received less attention. Read More
HONG KONG – South Korea's Peptron Inc. is looking to advance the development of sustained-release (SR) drugs, tapping into a global licensing deal with the U.S. NIH and focusing on developing new treatments for neurodegenerative disorders. Read More
