News Wire

Policymakers and insurers have been pushing people addicted to opioids into abstinence-based detox programs, but a new study concludes that methadone and similar drug-maintenance treatments save lives and money, Reuters reports. If the nearly 47,000 Californians who began treatment for opioid-use disorder…
Cytokinetics will scrap its late-stage drug to treat amyotrophic lateral sclerosis (ALS) after its key phase 3 trial failed to meet primary endpoints. Shares of the stock plunged more than 33% following the announcement, according to a report on BioSpace. The company said it has suspended development…
A significant proportion of children and young adults with treatment-resistant B-cell leukemia who participated in a small study achieved remission with the help of a new form of gene therapy, according by researchers at the Stanford University School of Medicine and the National Cancer Institute. The…
A new American Cancer Society (ACS) study calculates the contribution of several modifiable risk factors to cancer occurrence, expanding and clarifying the role of known risk factors, from smoking to low consumption of fruits and vegetables. The study finds more than four in 10 cancer cases and deaths…
Physicians at Kaiser Permanente in Southern California reduced the odds of prescribing an antibiotic for sinusitis by 22% using computer alerts to inform doctors when antibiotics may not be the best course of treatment, according to research published in the American Journal of Managed Care. The work…
Patients with cochlear implants that require frequent adjustments can now avoid long trips to distant specialists. The FDA has approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System (Cochlear Americas) through a telemedicine platform. The remote programming…
The FDA has approved an 0.1-mg epinephrine auto-injector (Auvi-Q, kaléo), the first such device specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds who are at risk for or have a history of serious allergic reactions.…
Acorda Therapeutics, Inc., is discontinuing clinical development of its Parkinson’s disease treatment tozadenant after five people died of sepsis in late-phase trials. Acorda announced that it is immediately ending dosing of all participants enrolled in its tozadenant studies. The company made this…
Obinutuzumab (Gazyva, Genentech) has won FDA approval for the initial treatment of advanced follicular lymphoma after improving patients’ survival in trials compared with rituximab-based regimens, the current standard of care. The FDA approved obinutuzumab in combination with chemotherapy, followed…
The FDA has approved emicizumab-kxwh (Hemlibra, Genentech) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors––the first new medication for these patients in nearly 20 years. Nearly one in three people…
The FDA has approved the first treatment for children and adults with mucopolysaccharidosis type VII (MPS VII), an extremely rare, progressive condition that affects most tissues and organs. Vestronidase alfa-vjbk (Mepsevii, Ultragenyx Pharmaceutical, Inc.) treats an inherited metabolic condition also…
In its quest for new ways to address the opioid epidemic, the FDA has cleared an existing electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for…
As a growing number of cancer treatments focus on specific genetic mutations, the FDA has authorized a next-generation sequencing (NGS) test than can rapidly identify genetic biomarkers in 468 genes––more than any test previously reviewed by the agency. IMPACT (Integrated Mutation Profiling of Actionable…
Five people have died of sepsis in late-phase trials of the Parkinson’s disease medication tozadenant (Acorda Therapeutics, Inc.), leading the company to monitor patients more closely, suspend enrollment in long-term safety studies, and discuss next steps with the FDA and the trials’ independent…
Benralizumab (Fasenra, AstraZeneca/MedImmune) has secured  FDA approval for the add-on maintenance treatment of patients with severe asthma 12 years of age and older with an eosinophilic phenotype. The FDA approval is based on results from the WINDWARD program, including the pivotal phase 3 exacerbation…

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