Breast Cancer

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Pharma News for AskBio, Merck, SELLAS, RemeGen
Bayer’s AskBio Initiates Phase II GenePHIT Trial; FDA Approves Merck’s KEYTRUDA Plus Chemoradiotherapy as Treatment for Stage III-IVA Cervical Cancer; FDA Fast Track Designation to SELLAS Life Sciences R/R AML; RemeGen’s RC88; Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer; Tonix Pharma’s TNX-102 SL for Fibromyalgia

Bayer’s AskBio initiates Phase II GenePHIT trial in Congestive Heart Failure Merck, also recognized as MSD in regions beyond the United States and Canada, has officially announced that the FDA has approved for the use of KEYTRUDA, Merck's anti-PD-1 therapy, in conjunction with chemoradiotherapy (CRT) for treatin...

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Pharma News for Bayer, Merck, Ayala, GARDP, AstraZeneca
New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea

Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea The Global Antibiotic Research & Development Partnership (GARDP), in partnership with Innoviva, Inc. (Nasdaq: INVA), had announced a significant milestone. They revealed that zolif...

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Roche’s HER2-Positive Breast Cancer Treatment Franchise

For most of the last century, breast cancer was categorized only by its location in the body; as a result, treatment results varied significantly. Patients with metastatic HER2+ breast cancer were traditionally treated with conventional chemotherapy regimens until trastuzumab became available. In September 1998, th...

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Top 10 Expected Oncology Drug Launches in 2023

Cancer is the world’s second leading cause of death. Every year, 10 million people die from cancer. Cancer kills 70% of people in low-to-middle-income countries. Cancer is estimated to cost the global economy USD 1.16 trillion per year. Millions of lives could be saved annually by implementing resource-appropriate ...

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Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...

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ENHERTU’s Journey in Cancer Treatment and Management

ENHERTU is an antibody-drug conjugate composed of an anti-HER2 antibody and a cytotoxic topoisomerase I inhibitor. Three components make up this ADC:  A topoisomerase inhibitor that is covalently linked to, Humanized anti-HER2 IgG1 monoclonal antibody (mAb) via, Tetrapeptide-based cleavable linker Rec...

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C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...

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Pharma News and Updates for Takeda, Gilead, and Odyssey
CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat

CHMP Gives Positive Opinion on Takeda’s Qdenga  The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH’s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product ...

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Pharma News for Amgen BioNTech and Gilead
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial

Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...

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Pharma News for Novartis and Gilead
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC

Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...

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