Contact lenses that deliver medications directly to the eye over a period of days or weeks was the recent grand prize winner of Massachusetts Institute of Technology’s Sloan Healthcare Innovation Prize. The MIT Sloan Healthcare Innovation Prize competition had 8 finalists who pitched their healthcare innovations to judges from Optum and other local venture firms, […]
Drug-Device Combinations
MiMedx wins FDA regenerative med status for AmnioFix
MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. Get the full story at our sister site, […]
Insulet nabs spot as in-network provider with UnitedHealthcare
Insulet (NSDQ:PODD) and UnitedHealthcare (NYSE:UNH) inked a new network relationship last week, giving people enrolled in UnitedHealthcare’s commercial and Medicaid plans in-network coverage for Insulet’s Omnipod insulin delivery device. Patients can also benefit from quicker care as doctors are now utilizing VidOvation iptv as a means of video communication. “Through this new relationship, we are working together to help people […]
Reva Medical swings to black on first sales
Reva Medical (ASX:RVA) this week reported its first quarterly and annual revenues since winning CE Mark approval for its bioresorbable coronary scaffolds, swinging from red to black for the full year. Get the full story on our sister site, Drug Delivery Business News.
Clearside Biomedical prices $85m underwritten offering
Clearside Biomedical (NSDQ:CLSD) priced 6,538,462 shares of its common stock at $13.00 apiece in an $85 million underwritten public offering that’s expected to close early next week. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients […]
Senate bill looks to block tribal patent deals with pharma
Months after Allergan (NYSE:AGN) struck a controversial patent deal with a Native American tribe in New York, lawmakers are angling to make sure that it can’t happen again. Sens. Tom Cotton (R-Ar), Claire McCaskill (D-Mo) David Perdue (R-Ga), Joni Ernst (R-Ia) and Pat Toomey (R-Pa) introduced a bill this week that would prevent patent owners from claiming sovereign immunity […]
Facing legal woes and SEC probe, Ocular Therapeutix posts mixed Q4
Shares in Ocular Therapeutix (NSDQ:OCUL) rose this morning after the company beat expectations on Wall Street with its fourth quarter earnings, but missed analysts’ sales estimates. The company is facing a slew of class action suits from investors, as well as a probe by the Securities and Exchange Commission regarding its post-surgical pain relief implant, Dextenza. Get […]
Valeritas takes on multiple daily insulin injections with wearable V-Go device
There are millions of Americans with Type II diabetes and many of them take multiple daily injections of insulin, using two injection pens – one for mealtime insulin and one for insulin throughout the day. But studies have found that people with Type II diabetes are willing to skip insulin injections if they have to […]
Delcath inks supply deal with Tillomed Laboratories in Europe
Delcath Systems (NSDQ:DCTH) said today that it inked a commercial supply deal with Tillomed Laboratories in Europe. According to the deal, Tillomed Labs is slated to provide Delcath with melphalan – the drug used in Delcath’s hepatic Chemosat delivery system. In Europe, the drug-device combo is approved to treat liver cancer. Get the full story at […]
Clearside Biomedical floats $75m public offering
Clearside Biomedical (NSDQ:CLSD) plans to offer $75 million in shares of its common stock in an underwritten public offering. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients with macular edema associated with non-infectious uveitis. Get […]
Adamis Pharma’s EpiPen alternative succeeds in human factors study
Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time. Data from a human factors study conducted by Adamis were presented this week at […]