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Home » Newsletters » BioWorld

BioWorld

April 9, 2014

View Archived Issues

Pharma: Other news to note

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

Clinic roundup

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

Financings roundup

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

Stock movers

Read More

Other news to note

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

Lack of regulatory clarity painful for patients, drugmakers

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

'Adaptive' parent Puma: Wall Street's confusion sabotages I-SPY 2 view

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

Barely on the radar, biotech M&As in China are growing

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, Roche ink potential $500M deal on epigenetic modulator

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

Bridging big data valley of death that comes before valley of death

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

Ready to file: Alkermes planning to submit NDA for antipsychotic in third quarter

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

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