Since it issued a warning on serious bleeding risk with aspirin in 2009, the agency has recorded eight new cases of severe bleeding caused by aspirin-containing antacid products.
The primary endpoint was a statistically significant change from baseline to week 26 compared to placebo in a patient-reported daily activity scale called Myasthenia Gravis-Activities of Daily Living
Novartis claims that the COMBI-d study of 423 patients is longest Ph III survival follow-up to date of BRAF V600E/K mutation-positive melanoma patients who received a targeted combination
The primary endpoint of the Beacon CRC trial is overall survival (OS), whiles secondary endpoints include progression-free survival (PFS) and objective response rate (ORR). The companies will carry
Baxalta develops, manufactures and commercializes therapies for orphan diseases and underserved conditions in hematology, immunology and oncology. The acquisition is expected to double Shire’s annual revenues to $20bn
The companies will develop next generation, precision-controlled chimeric antigen receptor (CAR) product candidates that feature Cell Design Labs’ molecular on/off switch technology. Under the deal, Cell Design Labs
Olmutinib is a third-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) intended to treat EGFR mutation-positive non-small cell lung cancer (NSCLC). Boehringer Ingelheim will evaluate
The licensing deal could generate up to $230m for AstraZeneca, and Gruenenthal will also pay royalties on sales. The agreement also gives Grünenthal exclusive rights to the fixed-dose
PNH is a ultra-rare, life-threatening blood disorder in which the immune system destroys red blood cells. The benefits of orphan drug status in the EU include a 10-year
The revefenacin phase 3 program, which includes two replicate efficacy trials and a single twelve-month safety study, is designed to support the product’s registration in the US. Theravance
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