The FDA has approved dexamethasone intraocular suspension (Dexycu, Icon Bioscience, Inc.), a long-acting treatment for inflammation associated with cataract surgery that allows patients to dispense with weeks of self-administered eye drops. Under the current standard of care for inflammation associated…
Two new studies suggest that patients do better when providers switch from using intravenous saline therapy to balanced fluids that closely resemble the liquid part of blood. Vanderbilt University Medical Center researchers believe the studies could improve survival and decrease kidney complications.…
Drug-makers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world, according to a Reuters report. Studying such real-world evidence (RWE) offers manufacturers…
The 340B Drug Pricing Program, a 25-year-old discount plan aimed at boosting resources for hospitals treating low-income patients, has not delivered on its promise to enhance care for the needy, according to research from Harvard Medical School and the NYU School of Medicine. The federal program was…
New expert guidance released by the Society for Healthcare Epidemiology of America offers advice to hospitals on determining when they can safely discontinue contact precautions for patients with multi-drug resistant bacteria. The framework, published in Infection Control and Hospital Epidemiology,…
Wilson’s disease patients had been champing at the bit for Teva Pharmaceuticals’ generic of Valeant Pharmaceuticals’ Syprine (trientine hydrochloride), which the company billed as a “lower-cost generic.” But after the drug launched this month, patients discovered Teva’s generic isn’t much…
The FDA has granted 510(k) clearance to Anika Therapeutics for a new hyaluronic-acid (HA)–based injection indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from…
The National Institutes of Health (NIH) is teaming with government, biopharmaceutical, life science, and nonprofit organizations to overcome obstacles and increase success for advancing promising treatments for Parkinson’s disease (PD). Part of the NIH Accelerating Medicines Partnership (AMP), AMP…
Teva Pharmaceutical Industries Ltd. has launched the first generic version of Reyataz (atazanavir, Bristol-Myers Squibb) capsules in the U.S. Atazanavir sulfate capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency…
The Trump administration has outlined policy changes it says will lower drug prices, but some experts are skeptical that the actions will accomplish that goal, according to a FierceHealthcare article. The White House’s Council of Economic Advisers (CEA) issued a 30-page report that offers a slew of…
The U.S. Patent & Trademark Office (USPTO) has overturned the sole unexpired patent keeping generic competition at bay for the prostate-cancer medication abiraterone acetate (Zytiga, Janssen Oncology). Generic drug-maker Argentum Pharmaceuticals LLC successfully challenged all claims of a Janssen patent…
In just four months, high doses of vitamin D reduced arterial stiffness in young, overweight/obese, vitamin-deficient, but otherwise still healthy African-Americans, researchers say. Rigid artery walls are an independent predictor of cardiovascular-related disease and death, and vitamin D deficiency…
The FDA has issued a warning letter to American CryoStem Corporation for marketing an adipose-derived stem cell product without the agency’s approval and for significant deviations from current good manufacturing practice requirements, including some that raise potentially significant safety concerns.…
Positive results have been reported from a crucial immunotherapy trial that used a combination of two Bristol-Myers Squibb (BMS) drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), to treat patients with a specific type of non–small-cell lung cancer patients. But previously undisclosed changes BMS…
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union, according to a Reuters report. The E.U. recommended 92 new drugs, including generics, up from 81, and China laid out…
