News Wire

In the last few decades, dozens of new breast cancer drugs—from chemotherapies to targeted compounds—have become available for clinical use, and mammogram technology has gone from film to digital. But are the changes making a difference in how many women die of breast cancer? The answer to that…
Researchers at Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital have developed a capsule that can deliver a week’s worth of human immunodeficiency virus (HIV) drugs in a single dose. This advance could make it much easier for patients to adhere to the strict schedule…
The FDA has granted a breakthrough therapy designation to voxelotor (previously called GBT440, Global Blood Therapeutics) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD. The breakthrough therapy designation for voxelotor was based…
Pembrolizumab (Keytruda, Merck) significantly improved recurrence-free survival compared with placebo in a phase 3 trial investigating the anti-PD-1 medication as monotherapy for surgically resected high-risk melanoma. Based on an interim analysis and following review by an Independent Data Monitoring…
Repeated vaccination for influenza in older adults reduced the severity of the virus and reduced hospital admissions, according to new research published in the Canadian Medical Association Journal. A team of Spanish researchers looked at the effect of repeated influenza vaccinations in the current…
The FDA has expanded the approved indications for denosumab (Xgeva, Amgen) to include the prevention of skeletal-related events in patients with bone metastases with multiple myeloma. The medication was already approved to prevent skeletal events in patients with bone metastases from solid tumors. The…
Workers would be allowed to band together to buy health insurance under a proposed rule released by the Department of Labor, The Hill reported. The proposal was issued in response to an executive order by President Trump, which would allow associations of workers to purchase cheaper health insurance…
Spark Therapeutics Inc. has priced its new gene therapy for a rare form of blindness at $850,000. That may not seem like much of a bargain, but it starts to sound better when you consider that the industry expected a cost of $1 million. The company said the price tag for voretigene neparvovec-rzyl (Luxturna)…
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.…
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…
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 approved valsartan oral solution (Prexxartan, Medicure), the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the United States. Previously, on October 31, 2017, Medicure announced that, through its subsidiary, Medicure International, Inc.,…
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 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 FDA has updated the product label for the cancer drug nilotinib (Tasigna, Novartis) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive…

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