News Wire

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…
Even though reducing waste in health care is a top priority, analysts have missed the waste that can be created when expensive infused drugs are packaged containing quantities larger than the amount needed, according to a new study by researchers at the Memorial Sloan Kettering Cancer Center. The authors…
As an additional safety measure against the emerging Zika virus outbreak, the FDA has issued new guidance to reduce the potential risk of Zika virus transmission from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses the donation of HCT/Ps from both living…
The FDA has given the nod to Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in certain patients. Emtricitabine and tenofovir alafenamide [TAF] are from Gilead Sciences, and rilpivirine is from Janssen…
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.…
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…
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…
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…

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