Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)
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- Category: Novartis
Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation
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- Category: Novartis
Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with hormone-receptor positive,
China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
Bristol-Myers Squibb - Pfizer Alliance ACROPOLIS™ real-world data program grows to sample size of nearly one million lives worldwide
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- Category: Bristol-Myers Squibb
The Bristol-Myers Squibb-Pfizer Alliance will present 15 Eliquis® (apixaban) posters at the ESC Congress 2018 held in Munich, Germany, August 25-29, 2018. Nine of the posters to be presented are new analyses from the global real-world data (RWD) program, ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), exploring the effectiveness and safety of anticoagulants, including Eliquis, among patients with non-valvular atrial fibrillation.
Novo Nordisk acquires Ziylo Ltd to accelerate its development of glucose responsive insulins
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- Category: Novo Nordisk
Ziylo and Novo Nordisk A/S today announced that Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology - synthetic glucose binding molecules - for therapeutic and diagnostic applications.
Merck awarded Australian CRISPR nickase patent for foundational genome-editing technology
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- Category: Merck Group
Merck, the vibrant science and technology company, today announced that the Australian Patent Office has allowed the company's patent application for the use of paired CRISPR nickases. Paired nickases represent a significant step in increasing safety by driving specificity through a highly flexible and efficient approach to reduce off-target effects.
Selumetinib granted orphan designation in Europe for neurofibromatosis type 1
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- Category: AstraZeneca
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
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- Bayer Cares Foundation promotes sustainable growth by supporting social impact pioneers with grants totaling EUR 1 million
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- Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its-kind treatment specifically designed for migraine prevention
- Roche reports very strong performance in the first half of 2018
- Atacand to be divested to Cheplapharm in Europe
- Novartis renews drug donation of Egaten® (triclabendazole) until 2022