Biolinerx Ltd.'s chief business officer, David Malek, told BioWorld Today that the phase III trial with stem cell mobilizer BL-8040 likely will not be a head-to-head trial with approved Mozobil (plerixafor, Sanofi SA), but the candidate's affinity to the same target, CXCR4, is "several orders of magnitude stronger," and could yield data regarded as superior. Read More
DUBLIN – Sosei Group is paying £35 million (US$45.2 million) for a 25.6 percent stake in Mina Therapeutics Ltd. in a deal that gives it a commanding view of the emerging field of small activating RNA (saRNA) therapeutics. Read More
There are plenty of diets that promise the ability to "eat all you want and still lose weight," to the gullible. But the sad reality is that it's the opposite. Read More
After a year of gathering feedback from regulators following completion of its phase II study, Soligenix Inc. said it reached accord with the FDA to advance SGX-942 (dusquetide) into a pivotal phase III study to treat oral mucositis in head and neck cancer (HNC) patients treated with chemoradiation (CRT). Read More
In the bitter political battle over a potential replacement for the Affordable Care Act, common ground between rivals can seem scarce. Yet, right there in the middle is one of the top priorities across parties: lowering the cost of prescription drugs. Read More
Perrigo Co. plc, of Dublin, said search warrants were executed at the company's corporate offices associated with an ongoing investigation by the U.S. Department of Justice Antitrust Division related to drug pricing in the pharmaceutical industry. Read More
Neurocrine Biosciences Inc., of San Diego, completed its private offering of 517.5 million aggregate principal amount of its 2.25 percent convertible senior notes due 2024, which includes $67.5 million aggregate principal amount of notes that were sold pursuant to the exercise of the initial purchasers' option to purchase additional notes. Read More
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., filed to seek approval for marketing authorization for fexapotide triflutate in five European countries: the Netherlands, the U.K., Germany, France and Spain. That first filing is for treating the symptoms of benign prostatic hyperplasia, or prostate enlargement. Fexapotide has been in development by Nymox for 15 years. (See BioWorld Today, Oct. 12, 2016.) Read More
Cellect Biotechnology Ltd., of Tel Aviv, Israel, said the FDA has provided the pre-investigational new drug (IND) meeting minutes supporting an IND submission for its Apograft. The submission review included the manufacturing (CMC) aspects, the preclinical data and the scope and design of the future clinical program. Read More
Spectrum Pharmaceuticals Inc., of Henderson, Nev., reported total product sales of $25.8 million for the first quarter, including net sales of $2.6 million for folate analogue Fusilev (levoleucovorin), $9.3 million for peripheral T-cell lymphoma drug Folotyn (pralatrexate), $2.8 million for radioimmunotherapeutic Zevalin (ibritumomab tiuxetan), $2 million for Marqibo (vincristine sulfate liposome injection), $2.9 million for HDAC inhibitor Beleodaq (belinostat) and $6.3 million for Evomela (melphalan). Spectrum recorded a net loss of $23 million, or 29 cents per basic and diluted share. Non-GAAP net income totaled $300,000, or 1 cent per share, beating estimates of a net loss of 2 cents per share. Read More
