Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction
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- Category: AstraZeneca
AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).
Amgen commences strategic collaboration with BeiGene to expand oncology presence in China
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- Category: Amgen
Amgen (NASDAQ: AMGN) announced the successful closing of the transaction to enter into a strategic collaboration with BeiGene that will significantly accelerate Amgen's plans to expand its oncology presence in China, the world's second-largest pharmaceutical market. BeiGene is a commercial-stage research-based oncology company with an established and highly experienced team in China,
Lilly opens Phase 3 clinical trial in RET-mutant medullary thyroid cancer
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- Category: Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) announced the opening of the LIBRETTO-531 clinical trial [NCT04211337] for selpercatinib, also known as LOXO-292, for treatment-naive RET-mutant medullary thyroid cancer (MTC) patients. This is the second Phase 3 trial to open for selpercatinib, a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase.
Lynparza approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
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- Category: AstraZeneca
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer)
Theravance Biopharma and Pfizer Inc. enter global license agreement for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitor program
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- Category: Pfizer
Theravance Biopharma Ireland Limited, a subsidiary of Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Pfizer Inc. (NYSE: PFE) ("Pfizer") today announced that the companies have entered into a global license agreement for Theravance Biopharma's preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized.
Amgen and Allergan submit Biologics License Application for ABP 798, biosimilar candidate to Rituxan® (rituximab)
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- Category: Amgen
Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.
Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
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- Category: AstraZeneca
AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.
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