News Wire

The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order…
ASP0113 (Astellas Pharma Inc./ Vical Incorporated), an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant recipients, did not significantly improve overall mortality and CMV end-organ disease through the first year following the transplant,…
Two phase 3 studies evaluating a fixed 110-mg subcutaneous dose of reslizumab (Cinqair, Teva Pharmaceutical Industries Ltd.) failed to meet their primary endpoints: reducing exacerbations in patients with uncontrolled asthma in one trial, and reducing oral corticosteroid doses in asthma patients dependent…
A U.S. map of flu activity issued Friday by the Centers for Disease Control and Prevention (CDC) was a sea of red: the color marking the highest levels of outpatient visits for an illness that continues to worsen this season. According to this week's CDC report, covering the week of January 7 to 13,…
In women with metastatic ovarian cancer restricted to the abdominal cavity (stage III), hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival with almost no additional side effects, according to research published in the New England Journal of Medicine. The research, led by the Netherlands…
A final analysis of the phase 3 ASPIRE trial showed that adding carfilzomib (Kyprolis, Amgen) to lenalidomide and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma, Amgen announced. The analysis, published…
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…
Cabozantinib (Cabometyx, Exelixis, Inc./Ipsen) improved overall and progression-free survival among previously treated liver cancer patients in the pivotal phase 3 CELESTIAL trial, according to results being presented at the 2018 ASCO-GI Symposium in San Francisco. At the planned second interim analysis…
Sick and tired of dealing with generic drug shortages and unpredictable price increases, five large U.S. health systems are taking an unusual step, Fierce Pharma reports: they're forming their own nonprofit generic drug-maker. Representing more than 450 hospitals, nonprofit groups Intermountain Healthcare,…
As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information, says FDA Commissioner Scott Gottlieb, MD. The agency is especially focused on information that can improve patient care and better…
The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by…
The FDA’s Center for Biologics Evaluation and Research has expanded the indication for Fluarix Quadrivalent (influenza vaccine, GlaxoSmithKline) to include use in people 6 months of age and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses…
Novartis has touted more clinical data showing its blockbuster drug secukinumab (Cosentyx) is better at treating plaque psoriasis than Johnson & Johnson’s rival product ustekinumab (Stelara), according to a BioPharma Dive report. Twelve weeks into the phase 3 CLARITY study, two-thirds of patients…
Early results from a key study have shown that a cocktail of Merck’s blockbuster drug pembrolizumab (Keytruda) and two chemotherapy agents helped lung cancer patients live longer and stopped the disease from advancing, according to a recent Reuters report. The results cement Merck’s position as…
The FDA has approved olaparib (Lynparza, AstraZeneca/Merck) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant,…

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