Biotech's great run has been achieved despite a number of macroeconomic events along the way that periodically spooked the general markets, but left the confidence in the industry largely unscathed. Although the sector has managed to shrug off those stock market perturbations, it was a different story at the end of second quarter as the markets headed south. Read More
Vertex Pharmaceuticals Inc.'s Orkambi won FDA approval Thursday, as largely expected, expanding the firm's reach into the cystic fibrosis (CF) market and serving as a "great example of what precision medicine can do and will do in the future," said Chairman, President and CEO Jeff Leiden. Read More
Holding back its wet age-related macular degeneration (AMD) program from the potential $1 billion deal with Biogen Inc. will let Applied Genetic Technologies Corp. (AGTC) reap more value in a collaboration later, as the firm deploys "a better understanding of vector design [that] has come about in the last five to seven years," which allows for "really being able to target the capsid, the promoter, the physical delivery method," CEO Sue Washer told BioWorld Today. Read More
BOGOTA, Colombia – Brazil's health surveillance agency, Anvisa, approved the commercialization of Sylvant (siltuximab) to treat patients with multicentric Castleman's disease (MCD) who do not have HIV and the human herpesvirus-8 infection. The application was filed by Sao Paulo-based Janssen-Cilag Farmacêutica, a subsidiary of Belgium's Janssen Pharmaceutical, which in turn is owned by Johnson & Johnson, of New Brunswick, N.J. Read More
LONDON – A phase IIb placebo-controlled trial reported in The Lancet is the first to show clinical efficacy of a gene therapy in the treatment of cystic fibrosis. Read More
As the realities of building a million-person research group for the federal Precision Medicine Initiative come into clearer focus, the thorny issues of data privacy, security and control moved to the fore during the second day of a National Institutes of Health-sponsored workshop on participant engagement and health equity. Read More
The reports of dying innovation in the U.S. have been greatly exaggerated if the number of patents granted is taken as the pulse of that innovation. Read More
Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application (NDA) to the FDA for a once-daily single tablet regimen that combines Gilead's emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical companies of New Brunswick, N.J.-based Johnson & Johnson. Read More
Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., reported dosing of the first patient in an investigator sponsored phase II proof-of-concept trial of the company's oral cyclin dependent kinase inhibitor seliciclib in Cushing's disease (CD). Clinicians at Cedars-Sinai, Los Angeles, were awarded a grant from the National Institute of Diabetes and Digestive and Kidney Diseases to evaluate seliciclib, which Cyclacel is evaluating in cancer, as a potential therapy for the disease. Read More
Seres Therapeutics Inc., of Cambridge, Mass., said it closed its IPO of 8,545,138 shares of its common stock at $18 each, which includes the exercise in full by the underwriters of their option to purchase 1,114,583 additional shares of common stock. The net proceeds from the offering are estimated to be approximately $139.8 million. Read More
Researchers from McGill University have shown that the immune system contribution to chronic pain differs in male and female mice. A large body of research suggests the hypersensitivity to normal stimuli, part of chronic pain, is due in part to immune cell signaling. Specifically, such signaling is from microglia to neurons. Read More
