Shares in Pavmed Inc. (NSDQ:PAVM) rose today after the medical device maker beat expectations on Wall Street with its third quarter results. The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year. Adjusted […]
Pharmaceuticals
Bigfoot Biomedical CEO hits back against CMS over data-sharing decision
Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has […]
BioCorRx inks deal with Nat’l Institute on Drug Abuse
BioCorRx (OTC:BICX) said today that it inked a confidentiality agreement with the National Institute on Drug Abuse, which will allow the group to share information and potentially work together on R&D and commercialization of BioCorRx’s therapies for opioid use disorder. The National Institutes of Health division has also agreed to participate as an observer at the […]
Study: Head-to-head comparison of opioid use disorder therapies finds similarities
A study published today in The Lancet found that two different therapies used to treat opioid use disorder – an extended-release naltrexone injection and a combination of buprenorphine and naloxone – have similar outcomes once patients get past the hurdle of starting treatment. This is the first study to compare the combination therapy and naltrexone head-to-head […]
Scilex seeks EU nod for ZTlido lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that it filed a marketing authorization application seeking approval for its ZTlido lidocaine patch. The San Diego, Calif.-based company said it is pursuing a hybrid regulatory pathway with the Medicines and Healthcare Products Regulatory Agency in the U.K., which will serve as the lead review agency. The company also plans […]
Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat
A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR). The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares […]
OncoSec Medical lands $9.3m in warrant exercise deal
OncoSec Medical (NSDQ:ONCS) said yesterday that it inked a warrant exercise agreement with unnamed holders of outstanding warrants to buy up to 5.5 million shares of the company’s common stock at an exercise price of $1.69 apiece. The San Diego, Calif.-based company raised $9.3 million in gross proceeds from the exercise of the warrants, which it plans […]
How DarioHealth turned the smartphone into a user-friendly glucose monitor
When DarioHealth (NSDQ:DRIO) CEO Erez Raphael looks at the medical device world, he sees solutions that were designed by healthcare professionals and doctors – and this presents a stark contrast with the consumer device industry, he pointed out. “We have seen there are a lot of cases, most of the cases in the industry, where the […]
FDA approves first pill with sensor to track ingestion
The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]
Urotronic launches feasibility trial of drug-coated balloon
Urotronic is launching a feasibility trial of its drug-coated balloon in men with narrowed urethras, according to StarTribune. The Plymouth, Minn.-based company’s Optilume device is inserted into a patient’s urethra and then inflates to dilate the urethra, allowing urine to leave the patient’s bladder. The Robust-II trial is slated to enroll 15 male patients and last […]