Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults
Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
Novartis has sold its stake in its consumer health joint venture with GlaxoSmithKline to its British rival for $13bn in an early move by Vas Narasimhan, the Swiss pharmaceuticals group's new boss, to focus on its core business.
Patients who understand the information provided about their health are more likely to adhere to a medicine regime and feel empowered to take steps towards healthier lifestyles. To what extent are pharma companies taking the initiative? Amanda Barrell reports.
The research compared patient care metrics at hospitals that had experienced a data breach and those that had not. For instance, the study examined the proportion of heart attack patients that die within 30 days of being admitted to a health system.
Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced publication of an article that demonstrated the Company’s proprietary ADAPT Biotargeting System™ (ADAPT) significantly out-performed standard HER2 testing in predicting response to trastuzumab (Herceptin®) for breast cancer patients.
First allogeneic stem cell therapy to receive central marketing authorization approval in Europe. Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries1
AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.
An attempt to develop a safe and effective "male pill" is making headway, according to preliminary results of a small study. In a four-week trial of men under 50, an experimental hormone-based birth control pill was found to be "well-tolerated."
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