Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.The Lyon, France-based company developed the controlled-release oral formulation of sodium oxybate using its Micropump technology. The randomized, double-blind trial has enrolled […]
Clinical Trials
Galderma wins FDA nod for dermal fillers
Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made with XpresHAn technology to manufacture injectable gels with customized hyaluronic acid crosslinking in each product. The federal watchdog’s approval was based on 2 […]
BioDelivery’s topical gel for diabetic neuropathy fails in phase IIb trial
BioDelivery Sciences International (NSDQ:BDSI) said today that its clonidine topical gel for pain relief in patients with diabetic neuropathy failed in a phase IIb clinical trial. Raleigh, N.C.-based BioDelivery will halt any further development of the painkiller. In the phase IIb clinical trial, BioDelivery’s topical gel did not demonstrate a statistically significant difference in pain relief […]
National cancer group recommends Sirtex’s microspheres for metastatic colorectal cancer
Sirtex Medical (ASX:SRX) said yesterday that the National Comprehensive Cancer Network has recommended the company’s radioactive microspheres in its Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. The NCCN panel uniformly agreed that selective internal radiation therapy with yttrium-90 microspheres is an option for patients with metastatic, chemotherapy resistant colorectal cancer. The recommendation was […]
Novocure touts positive TTFields data for pancreatic, ovarian cancer
Novocure (NSDQ:NVCR) shares were up 6% after hours yesterday after the company released positive data for its “tumor treating fields” combined with chemotherapy for pancreatic and ovarian cancer. The St. Helier, N.J.-based company’s TTFields are low-intensity, alternating electric fields meant to inhibit cancer cell replication and cause cell death. Novocure presented data from its phase II […]
AngioSoma taps new CEO
AngioSoma (OTCQB:SOAN) said today that it named Ken Stephenson to the Montgomery, Texas-based company’s corner office. Alexanderia Blankenship will now serve as chief operating officer and executive VP. Stephenson has worked with hospitals, health insurance organizations and physician’s offices throughout Texas, according to the company. He previously helped set up practices for interventional radiologists and […]
PellePharm announces launch to develop topical gel for basal cell carcinoma
PellePharm announced its launch today, with financing from BridgeBio Pharma. The Menlo Park, Calif.-based company is developing a topical gel to treat basal cell carcinoma, including the tumors that result from Gorlin syndrome. The company’s topical inhibitor compound, patidegib, acts on the hedgehog pathway – a signaling pathway that transmits cellular information for adult tissue […]
Aerie completes enrollment of phase III trial for intraocular pressure eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension. The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin […]
SRI wins $150m grant to develop HIV prevention products
SRI International said today that it landed a $150 million contract from the National Institutes of Health‘s National Institute of Allergy and Infectious Diseases and the Division of AIDS to support the development of HIV microbicides and other pre-exposure agents. According to the 7-year deal, the research institute will provide preclinical product development services for non-vaccine […]
Researchers show drug, catheter combo speeds up labor delivery
Using the drug misoprostol in combination with a Foley balloon catheter to induce labor can lead to a speedier delivery, with women delivering several hours earlier than either method alone, according to research from the University of Pennsylvania. The team’s work was published in Obstetrics & Gynecology. Nearly 1 million women who deliver in the U.S. […]
