Sen. Claire McCaskill (D-Mo.) said that Teva Pharmaceuticals (NYSE:TEVA) is “stonewalling” a Senate probe into the the role that opioid manufacturers have in the nation’s opioid crisis. In the senator’s initial inquiries with the generic drugmaker, McCaskill requested an array of documents detailing arrangements between Teva and its customers, as well as internal reviews of pharmacies […]
Pain Management
Sorrento Therapeutics wins FDA nod for post-shingles pain patch
Shares in Sorrento Therapeutics (NSDQ:SRNE) soared today after the company announced that the FDA approved its ZTlido lidocaine pain patch designed to treat patients with post-shingles neuralgia. The company resubmitted its application for ZTlido to the FDA last year after it was rejected by the U.S. regulatory agency in 2016. “ZTlido was designed to solve a […]
Facing legal woes, PixarBio takes aim at InVivo
PixarBio (OTC:PXRB) faces its own legal problems: a possible lawsuit by the SEC, legal action by a disgruntled employee who is demanding unpaid wages and former landlords looking for $1.8 million in unpaid rent. But the 7-person biotech is also looking to launch some litigation of its own, according to a recent document it filed with […]
KemPharm wins FDA nod for short-term pain prodrug
Shares in KemPharm (NSDQ:KMPH) soared today after the company said that the FDA approved a re-submitted application for its pain-relief prodrug, Apadaz. The product, which combines benzhydrocodone and acetaminophen, is indicated for the short-term management of acute pain. The FDA rejected KemPharm’s first attempt at regulatory approval for Apadaz in 2016. Today’s win for KemPharm is […]
Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer. The committee’s feedback doesn’t necessarily mean the immediate end for Pacira’s […]
Ensysce Biosciences wins fast track status for abuse-deterrent oxycodone
Ensysce Biosciences said this week that its extended-release oxycodone prodrug won fast track status from the FDA. The San Diego, Calif.-based company is developing the abuse-deterrent drug as a pain management therapy for people with moderate to severe chronic pain. Ensysce’s prodrugs are only activated once they reach the small intestine, where enzymes set off […]
How conversations with virtual people could help mitigate the opioid crisis
It often starts in the doctor’s office or the emergency room. A patient has broken their leg and will be in pain for weeks. Another patient has had back surgery and is on their way home, but it will take time before they’re fully recovered. A third patient has returned for a consult about the […]
FDA, FTC warn companies over deceptive opioid cessation products
The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is […]
Braeburn dealt setback over monthly, weekly opioid abuse therapy
The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with opioid use disorder. The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional […]
NeuroMetrix, GSK ink development deal for Quell wearable pain-relief tech
Shares in NeuroMetrix (NSDQ:NURO) soared this morning after the company announced it would partner with GlaxoSmithKline (NYSE:GSK) to expand development of NeuroMetrix’s Quell wearable pain-relief device. According to the terms of the deal, GSK’s consumer healthcare business will have exclusive rights to the Quell system for markets outside of the U.S., while NeuroMetrix will retain ownership […]
