Browsing items tagged “AstraZeneca | EVERSANA”

FDA Grants Enhertu Orphan Drug Designation for Gastric Cancer

Region: NORTH AMERICA | Type: Regulation | Keywords: #astrazeneca #daiichisankyo #deruxtecan #enhertu #orphan #trastuzumab PRICENTRIC BRIEF: The FDA has granted Orphan Drug Designation to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer The designation was supported by data from the Phase II DESTINY-Gastric01 trial, in which Enhertu demonstrated a statistically significant and clinically meaningful improvement in objective response […]

AstraZeneca Plans First Deliveries of COVID-19 Vaccine for September

Country: UNITED KINGDOM, UNITED STATES | Region: EUROPE, NORTH AMERICA | Type: Drug Launch | Keywords: #astrazeneca #az #azd1222 #coronavirus #covid19 #distribution #manufacturing #r&d #supplychain #vaccine PRICENTRIC BRIEF: AstraZeneca (AZ) concluded the first agreements for over 400 million doses of a COVID-19 vaccine and secured manufacturing capacity for a total of one billion doses so far, the company announced, with the first doses set to be delivered in September 2020 AZ has […]

Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]

FDA OK’s AZ & Merck’s Lynparza Plus Bevacizumab in HRD-Positive Ovarian Cancer

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #astrazeneca #fda #merck PRICENTRIC BRIEF: Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and […]

Japan’s PMDA Evaluates Side Effects of Insulins, Cancer Drugs

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Regulation | Keywords: #astrazeneca #cancer #elililly #insulin #janssen #novonordisk #pmda #sideeffects PRICENTRIC BRIEF: Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is currently investigating new side effect risks for 15 insulins and two cancer drugs The PMDA is examining risks associated with Eli Lilly’s Humalog/Lyumjev (insulin lispro) and Novo Nordisk’s Xultophy (insulin degludec + liraglutide) and Fiasp (insulin aspart) Also under review […]