Armas Pharmaceuticals Inc. (Armas), has begun the new year with launches of four generic injectables: Caffeine Citrate, Docetaxel, Gemcitabine and Verapamil HCI. These products are now a part
Imbruvica is already approved in Europe for chronic lymphocytic leukaemia as a monotherapy or in combination with obinutuzumab in patients who were previously untreated for their condition. The
The new analysis showed that the percentage of patients with complete clearance of all lesions was statistically significantly higher in the VP-102 group than vehicle, across all body
By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug
The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020. “The FDA’s acceptance of our application
As per the terms of the deal, the Japanese pharma company and Adaptimmune will select up to three targets for their collaboration and will co-develop T-cell therapy candidates
The organizations will form co-owned, joint development companies (“JDCs”) that will integrate Atomwise’s AI technology and BioMotiv’s deep expertise in preclinical and clinical development to translate innovative academic
Under the marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA), the company has asked the regulator to review the potential use of fostemsavir in combination
The rolling submission allows completed sections of an NDA to be reviewed by the FDA on an ongoing basis. Specifically, Alnylam has submitted the non-clinical components to the
The Phase 3 study, which enrolled 2,838 adults, age 18-45 years, met both the primary and secondary endpoints. “We are thrilled with the results of the CONSTANT study,
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