Shares in Titan Pharmaceuticals (NSDQ:TTNP) fell today after the company missed expectations on Wall Street with its third quarter results. The San Francisco, Calif.-based company posted a net loss of -$4.2 million on sales of $40,000 for the 3 months ended Sept. 30, for bottom-line loss of -60% on sales growth of 53.8% compared with the […]
Pain Management
Rivanna tackles epidural failure rates with its hand-held imaging device
When they were students in the biomedical engineering department at the University of Virginia, Will Mauldin and Kevin Owen found a problem that needed solving – anesthesiologists often fail to successfully place an epidural on their first try. It’s a problem that costs the medical system more than $1.5 billion each year, according to Rivanna Medical. […]
Anika’s Monovisc therapy gets green light in Australia
Anika Therapeutics (NSDQ:ANIK) said yesterday that regulatory authorities in Australia approved the company’s single injection viscosupplement, Monovisc, for the treatment of pain associated with osteoarthritis of the synovial joints. This latest regulatory win means that Monovisc is commercially available in more than twenty countries, including the U.S. and Canada. The Bedford, Mass.-based company said it plans […]
AcelRx shares tumble after FDA rejects Dsuvia painkiller
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) fell more than -50% this morning after the company announced that it received a complete response letter from the FDA for its Dsuvia sufentanil sublingual tablet. The FDA told the company that it can’t approve the new drug application in its present form, saying that AcelRx needs to collect additional data […]
CDC campaign uses testimonials to fight prescription opioid epidemic
The Centers for Disease Control and Prevention today launched a campaign featuring real-life stories of people recovering from opioid-use disorder and people whose loved ones have died due to a prescription opioid overdose. The campaign was designed to boost awareness among Americans about the risks linked with prescription opioids. 91 people die everyday in the U.S. […]
Braeburn’s buprenorphine depot wins priority review from FDA
Braeburn Pharmaceuticals said today that the FDA granted priority review to the company’s CAM2038 NDA. The investigational weekly and monthly buprenorphine depot injection was designed to treat adults with opioid use disorder. The regulatory agency is slated to make a decision about CAM2038 by January 10, 2018. “FDA’s acceptance of our NDA for CAM2038 under […]
Fast-dissolving opioid dependence tablet wins EU recommendation
Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies […]
FDA to review re-submitted application for Sorrento’s lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that the FDA has received the resubmitted version of a new drug application for its lidocaine patch, ZTlido. The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia. The FDA said it is slated to finish reviewing the company’s NDA by […]
Bioventus wins FDA nod for knee osteoarthritis pain injection
Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis. When a person develops osteoarthritis in their knee, the cartilage breaks down and so does the synovial fluid that provides lubrication to joint tissues. Hyaluronic acid provides cushioning and lubrication to the knee, […]
Sorrento seeks FDA nod for lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) said today that its subsidiary Scilex Pharmaceuticals resubmitted the new drug application for its lidocaine patch, ZTlido, to the FDA. The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia. “We are excited about the opportunity to bring to the market a product that […]
