Bluebird Bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) today announced that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.
Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced publication of an article that demonstrated the Company’s proprietary ADAPT Biotargeting System™ (ADAPT) significantly out-performed standard HER2 testing in predicting response to trastuzumab (Herceptin®) for breast cancer patients.
AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.
AbbVies stock $ABBV is getting hammered this morning after its $10 billion Rova-T program posted poor mid-stage results for third-line small cell lung cancer, forcing the company to scuttle any plans to seek an accelerated approval for the closely-watched drug after talks with skeptical regulators.
Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
TCR2 Therapeutics Inc., an immuno-oncology company pioneering a novel class of T cell receptor (TCR)-based cellular therapies for solid tumors and blood cancers, announced today the completion of an oversubscribed Series B financing of $125 million.
GlaxoSmithKline's new CEO Emma Walmsley isn’t the only one shaking things up at the top of the British drugmaker.
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