Page 13 - Project Orbis News Today

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer News provided by Share this article Share this article SILVER SPRING, Md., April 16, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for...

FDA approves immunotherapy for first-line treatment of advanced gastric cancer Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. Todays approval is the first treatment in more than a de...

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival Trodelvy Significantly Reduced the Risk of Death by 49% Compared with Single-Agent Chemotherapy in the Phase 3 ASCENT Study – – Trodelvy is Under Regulatory Review in the EU and in the United Kingdom, Canada, Switzerland and Australia as Part of Project Orbis – Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administrat...

(0) NEW YORK, NY / ACCESSWIRE / April 1, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the first patient has been dosed in an open-label Phase 2 clinical trial of belumosudil, the Companys ROCK2 inhibitor, in patients with diffuse cutaneous systemic sclerosis (dcSSc), a chronic immune disorder characterized by fibrosis of the skin and internal organs. The Phase 2 study (KD025-215) will enroll up to 15 adults with dcSSc who will receive orally administered belumosudil 200 mg tw...

BridgeBio, Helsinn Ink Up-to-$2.4B Infigratinib Partnership April 1, 2021 BridgeBio Pharma will join with Swiss pharma Helsinn Group to co-develop and commercialize infigratinib (BGJ398) in oncology and other indications except achondroplasia and other skeletal dysplasias, through a partnership that could generate up to approximately $2.45 billion for BridgeBio. [Helsinnn Group] Share BridgeBio Pharma will join with Swiss pharma Helsinn Group to co-develop and commercialize infigratinib (BGJ398...

Mar 4, 2021 10:54am The FDA has expanded Pfizers Lorbrena approval to include front-line ALK-positive non-small cell lung cancer. Pfizer’s Lorbrena has finally broken into front-line non-small cell lung cancer, where Novartis, Roche and Takeda are already jockeying for a niche market. The FDA expanded Lorbrena’s use into newly diagnosed patients with ALK-positive NSCLC, Pfizer said Wednesday. With that front-line nod, the agency converted Lorbrenas conditional green light for previously tre...

Why governments need to rethink their regulatory framework in 2021 - Magazine Article - PharmaTimes

UK approval for Seagen’s oral HER2 inhibitor Tukysa MHRA has authorised drug for HER2-positive advanced breast cancer Seagen’s oral HER2 drug Tukysa has been granted authorisation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of HER2-positive advanced breast cancer. The MHRA has cleared Tukysa (tucatinib) as an add-on therapy to Roche’s anti-HER2 antibody Herceptin (trastuzumb) plus Xeloda (capecitabine) for adults patients with HER2-positive ...

Operator Good morning to those joining from the U.K. and the U.S. Good afternoon to those in Central Europe. Welcome, ladies and gentlemen, to AstraZenecas full-year 2020 results conference call and webcast for investors and analysts. Before I hand it over to AstraZeneca, Id like to read the safe harbor statement. The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking sta...

In the fall of 2016, Alnylam Pharmaceuticals was looking to expand. The Cambridge, Massachusetts–based company had therapies based on RNA interference (RNAi) technology in late-stage clinical testing for a handful of rare diseases, and wanted to establish a presence in Europe to better serve patients there. By the end of the following year, the company had opened offices in Maidenhead, UK; Zug, Switzerland; and Amsterdam, the Netherlands, to serve as its three European hubs. Scouting for new ...