Astrazeneca plc acknowledged receipt of a complete response letter (CRL) from the FDA on its new drug application (NDA) for sodium zirconium cyclosilicate, an oral suspension designed to treat hyperkalemia (HK). The candidate, better known as ZS-9, was the prize in Astrazeneca’s 2015 acquisition of ZS Pharma Inc. for $2.7 billion. Read More
LONDON – As the days count down to the June 23 referendum on whether or not the U.K. should remain in the European Union (EU), the predicted impacts of either course are getting direr by the day. Read More
After presenting full results from the phase III trial with Portola Pharmaceuticals Inc.’s oral betrixaban for prophylaxis of venous thromboembolism (VTE) in France, study steering committee leader Michael Gibson told BioWorld Today that the company is “beginning to chip away at the chip of the iceberg with respect to the data and will continue to work closely with [the FDA] to explore all their questions.” South San Francisco-based Portola plans to submit a new drug application to the FDA in the second half of this year, and pursue approval in Europe as well. Read More
Since participant data will form the bedrock of the Precision Medicine Initiative (PMI), those who gather, store and use that information will have to give more than lip service to protecting it and using it responsibly. Read More
WASHINGTON – Former Advamed CEO Stephen Ubl discussed the need to create a sound regulatory and reimbursement environment for personalized medications in his new role as the head of the Pharmaceutical Research and Manufacturers of America (PhRMA), during a keynote at last week’s conference sponsored by the Personalized Medicine Coalition. Read More
Sage Therapeutics Inc., of Cambridge, Mass., said it completed enrollment in a phase II placebo-controlled study testing SAGE-547 in women with severe postpartum depression. The company decided to include 30-day follow-up data in its top-line announcement, with those results expected in July. The study is designed to enroll up to 32 patients, with a primary endpoint measured using the Hamilton Rating Scale for Depression score from baseline to 60 hours. Read More
Pronai Therapeutics Inc., of Vancouver, British Columbia, said it obtained an exclusive license from Carna Biosciences Inc., of Kobe, Japan, for worldwide rights to develop and commercialize AS-141, a small-molecule kinase inhibitor targeting CDC7. Overexpression and activity of CDC7 is correlated with poor clinical outcomes and poor survival in a broad range of hematological malignancies and solid tumors. Read More
Atossa Genetics Inc., of Seattle, said it entered a stock purchase agreement with Aspire Capital Fund LLC, which has committed to purchase up to $10 million of Atossa’s common stock over 30 months, based on prevailing market prices over a period preceding each sale. Read More
Men whose blood cells had lost the Y chromosome were at higher risk of developing Alzheimer's disease in three independent case-control and prospective studies. Most genetic risk studies focus on specific mutations or structural variations in the genome, but men can develop a far more wholesale genomic change – loss of the Y chromosome in specific cells. Recent studies have shown that roughly 15 percent of men over the age of 70 have lost the Y chromosome in at least 10 percent of their blood cells. Read More
