Lipella Pharmaceuticals Inc., of Pittsburgh, Pa., said a physician-initiated, double-blind, randomized, placebo-controlled trial comparing the intravesical instillation of a topical botulinum toxin type A formulation (LP-09) to placebo in 24 subjects diagnosed with overactive bladder (OAB) showed significant reductions in both urinary urgency and urinary frequency. Read More
Oncolytics Biotech Inc., of Calgary, Alberta, reported additional data from its phase III REO 018 study testing Reolysin in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers. Read More
Ohr Pharmaceutical Inc., of New York, entered subscription agreements with institutional and accredited investors for the sale of its common stock in a registered direct offering, selling 1.8 million shares for $10 each, for gross proceeds of about $18 million. Read More
Hemispherx Biopharma Inc., of Philadelphia, said preclinical data published in American Journal of Pathology showed that Toll-like receptor (TLR) 3-targeting Ampligen displayed a discordance between rodent and human inflammatory responses, unlike other TLR stimulators that trigger pro-inflammatory cascades that can lead to significant side effects in patients. Read More
Lengthening delays in the Drug Enforcement Administration's (DEA) scheduling of new prescription drugs as controlled substances are impeding patient access to much-needed therapies and could be costing lives, a House subcommittee was told during a hearing on legislation intended to improve transparency and predictability at both the DEA and FDA. Read More
Despite years of biotech and pharma sporadically deploying the adjust-as-you-go approach for good clinical purposes, the phrase "adaptive trial design" still puts the fantods into company backers. Read More
SHANGHAI – Chinese biotech companies are only a small part of the M&A pie in the drug sector here. Although big pharma deals continue to take more than half of all M&A deals in life sciences with 20 percent growth over last year, innovative biotech hardly registers on the scale. Read More
Oryzon Genomics SA is getting $21 million in up-front and near-term milestones and could earn more than $500 million in total from a partnering deal with Roche AG on its lysine-specific demethylase-1 (LSD1) inhibitor program. The agreement is a major validation for Barcelona, Spain-based Oryzon – and for an epigenetic target with a growing body of evidence linking it to cancer and several other broad indication areas. Read More
SAN DIEGO – At the American Association for Cancer Research annual meeting, Lynda Chin had a blunt reminder for her audience. "No matter how much data you have," she said, "drugs, tests and devices are the only thing patients will benefit from." Read More
Alkermes plc said Tuesday that favorable phase III data on its long-acting injectable antipsychotic (LAI), aripiprazole lauroxil, will support its filing an FDA new drug application for the investigational schizophrenia treatment in the third quarter, positioning the company to benefit from trends favoring LAIs. Read More
