Augmenix Inc. said today that long-term outcomes data from the company’s phase III clinical trial evaluating its hydrogel spacer, SpaceOAR, were published in the International Journal of Radiation Oncology Biology and Physics. The spacer is designed to separate the rectum and prostate during prostate cancer radiotherapy, according to the Waltham, Mass.-based company. The newly published data were […]
BioTime and subsidiary establish cell manufacturing facility in Israel
BioTime Inc. (NYSE:BTX) and its subsidiary Cell Cure Neurosciences said today that it is establishing an 800 square meter cell manufacturing facility at the Hadassah University Hospital in Jerusalem. The manufacturing center will be staffed initially by 30 employees, according to the companies, and will be prepared to produce OpRegen for BioTime’s ongoing clinical trial […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
Primatene Mist Inhaler rejected by FDA
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
Provectus axes CEO Culpepper for expense account violations
Provectus Biopharmaceuticals Inc. (OTCQB:PVCT) said this week that its board of directors voted unanimously to terminate CEO and chief operating officer Peter Culpepper, after an internal investigation revealed that Culpepper violated the company’s expense account reimbursement policy. The Knoxville, Tenn.-based company said it has established a search committee and is actively seeking a new CEO. […]
Researchers develop nanodiscs to deliver personalized cancer therapy
Researchers from the University of Michigan have developed nanodiscs that deliver a customized therapeutic vaccine to treat colon and melanoma cancer in mice. The team’s work was published in Nature Materials. “We are basically educating the immune system with these nanodiscs so that immune cells can attack cancer cells in a personalized manner,” senior author James Moon said […]
IntelGenx, Endo Ventures ink development and commercialization deal
IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new product using IntelGenx’s VersaFilm drug delivery technology to bring to the market in the U.S. Endo will have certain exclusive rights to market and sell the product in the […]
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba. CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on […]
Biogen, Ionis win FDA approval for first spinal muscular atrophy drug
Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a progressive and often fatal genetic disease that causes muscle weakness in infants and toddlers. The FDA previously granted Biogen’s application fast track designation […]
Mesoblast gains on A$29m investment deal with Mallinckrodt
Shares in stem cell company Mesoblast Ltd (ASX:MSB) rose 7% to A$1.51 yesterday after it said that it entered into an equity purchase agreement with US drugmaker Mallinckrodt Pharmaceuticals (NYSE:MNK). Mallinckrodt will buy 20.04 million, or nearly 5%, of Mesoblast’s ordinary shares for A$1.48 apiece. According to the agreement, Mallinckrodt will have 9 months to […]