News Wire

The pivotal clinical trial in the development program for subcutaneous (SC) ceftriaxone has met its targeted endpoints, scPharmaceuticals, Inc., has reported. The trial’s primary endpoint was noninferior antimicrobial coverage compared with that of the same dose given by intravenous (IV) infusion.…
Amgen has announced the submission of a supplemental biologics license application (sBLA) to the FDA for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph–) relapsed or refractory B-cell precursor acute…
Spurred by the 2009 stimulus package and the 2010 Patient Protection and Affordable Care Act, the federal government has offered hospitals financial incentives to adopt electronic health records (EHRs), which are expected to add efficiency and reduce errors by linking physicians’ patient records,…
French scientists say they have proved a link between Zika virus infection and Guillain-Barré syndrome, a rare disorder in which the body’s immune system attacks part of the nervous system, according to a Reuters report. In a retrospective study, researchers led by Dr. Arnaud Fontanet of France’s…
Flibanserin (Addyi, Valeant Pharmaceuticals), a drug designed and approved to boost women’s sex drive, shouldn’t be recommended in treatment guidelines or routinely prescribed until future studies are conducted to prove its benefits in a wider range of women, according to a new study published in…
An estimated 127 million Americans––one in two adults––are affected by a musculoskeletal condition, and these disorders cost an estimated $213 billion in annual treatment, care, and lost wages, according to a new report issued by the United States Bone and Joint Initiative (USBJI). The report…
New study data have shown that low-dose, extended-release aspirin (162.5 mg) (Durlaza, New Haven Pharmaceuticals) is well tolerated, with a safety profile comparable to that of low-dose, immediate-release aspirin, and delivers antiplatelet control for 24 hours in high-risk cardiovascular and diabetes…
The FDA has granted orphan drug designation to the WT1 cancer vaccine (SELLAS Life Sciences Group) for the treatment of patients with malignant pleural mesothelioma (MPM). A phase 2 trial of the vaccine in MPM patients improved overall survival and doubled progression-free survival. SELLAS now plans…
Aldeyra Therapeutics has reported positive results from a phase 2a clinical trial of topical ocular NS2 used to treat allergic conjunctivitis. The drug demonstrated statistically significant and sustained clinical effects, such as reduction of ocular itching and tearing. The randomized, parallel-group,…
Tremelimumab, one of AstraZeneca's top drug prospects, has failed to improve survival in mesothelioma patients in its phase 2b trial, FierceBiotech reports. The drug has recently shown promise in combination with durvalumab for treatment of non–small-cell lung cancer (NSCLC). MedImmune, an AstraZeneca…
Genentech has announced the results from two phase 3 studies that evaluated the efficacy and safety of lebrikizumab in people with severe asthma. In the LAVOLTA I trial, lebrikizumab reduced asthma exacerbations and improved lung function, but not as significantly as in its phase 2 trials. In the LAVOLTA…
The FDA has approved Afinitor (everolimus tablets) as a treatment for adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic, Novartis has announced. Afinitor becomes the…
Bundled payments have been touted as a way to keep skyrocketing health care costs under control, but a new analysis by the Kaiser Family Foundation (KFF) has raised early doubts about some of the initiatives being undertaken by the Centers for Medicare and Medicaid Services (CMS). A recent American…
In January, a pregnant Brazilian woman infected with the Zika virus had a stillborn baby who had signs of severe tissue swelling as well as central nervous system defects that caused near-complete loss of brain tissue. This is the first report to indicate a possible association of congenital Zika virus…
Health insurance exchanges created to help millions of people find coverage are turning into money-losing ventures for many insurers, according to an Associated Press report posted on the Medical Xpress website. For example, the nation’s largest insurer, UnitedHealth Group Inc., could lose as much…

Pages