Breast Cancer

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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 or Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody and a cytotoxic topoisomerase I inhibitor. Three components make up this antibody-drug conjugate (ADC):  A topoisomerase inhibitor that is covalently linked...

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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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Latest Pharma News for AstraZeneca and Bayer
FDA Approves AstraZeneca’s Enhertu; Bayer Wins FDA Approval for Prostate Cancer Therapy, Nubeqa; Gilead Sciences to Acquire MiroBio; AstraZeneca & Merck’s Lynparza Gets EU Approval; Pfizer to Acquire Global Blood Therapeutics; Sironax Raises USD 200 Million

FDA Approves AstraZeneca’s Enhertu as First Targeted Therapy for HER2-low Cancer Enhertu, developed by AstraZeneca and Daiichi Sankyo, has been approved by the FDA as the first targeted therapy for HER2-low breast cancer, a new subtype of the disease previously categorized as HER2-negative. It has the potential ...

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Latest Pharma News AbbVie and Byondis
Byondis’s HER2-targeting ADC trastuzumab duocarmazine; AbbVie Migraine Drug Atogepant; Grünenthal Acquires Bayer’s Testosterone Drug Rights; Vertex Acquires ViaCyte; Merck & Orion Announces Collaboration; Verve Starts Trials of Cholesterol Drug; Kyowa Kirin Drops Nourianz follow-up KW-6356; FDA Orphan Drug and Fast Track Designations to CV-01

Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and Ast...

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Pharma News for Ipsen, BioMarin and AbbVie
Ipsen to Buy Epizyme; BioMarin’s Gene Therapy for Hemophilia; AbbVie’s Qulipta for Chronic Migraine; FDA Approves Breyanzi for R/R LBCL; NDA Filed for Elacestrant in ER+/HER2- Breast Cancer; EU Approval to Enhertu for Breast Cancer; FDA Approves Novartis’ BRAF-positive Tumor Combination; GSK’s Hepatitis B Vaccine, Bepirovirsen

Ipsen to Buy Biopharmaceutical Company Epizyme for USD 247 Million The restructuring of French manufacturer Ipsen has progressed with a takeover agreement for US competitor Epizyme and its cancer drug Tazverik in a deal for slightly less than USD 250 million. Ipsen is proposing USD 1.45 per share for Epizyme, va...

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