April 5 (Reuters) - The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo (4568.T), opens new tab and AstraZeneca's (AZN.L), opens new tab drug to treat patients with a type of solid tumor.
Daiichi Sankyo`s Enhertu (fam-trastuzumab deruxtecan-nxki) Receives Suppl Approval in the U.S.
Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd, announced a five-year partnership with Sandoz AG (Sandoz) which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.
Sandoz`s Herwenda (trastuzumab) Receives Approval in Europe
KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Progression-Free Survival (PFS) Versus Trastuzumab and Chemotherapy in First-Line HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Basel, September 18, 2023 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use), developed by EirGenix, Inc.
Glenmark Pharmaceuticals Ltd on Thursday said it has slashed the price of breast cancer drug Trastuzumab by bringing its brand Trumab at Rs 15,749 for a 440 mg vial from Rs 54,000 earlier. nnnRead more at: nhttps://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-pharma-slashes-price-of-breast-cancer-drug-trastuzumab/articleshow/101015785.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
NIJMEGEN, Netherlands, May 15, 2023 /PRNewswire/ -- Byondis B.V., an independent, Dutch clinical-stage biopharmaceutical company creating precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). With this BLA, Byondis sought approval for its anti-HER2 antibody-drug conjugate (ADC) in HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a disease with a high unmet medical need.
New Delhi: Biotechnology major Biocon on Friday said the Bengaluru-based plant o ..
Seagen Announces FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer