Shots: Mulpleta is approved based on two randomized, placebo-controlled trials (L-PLUS 1 & 2) involving 312 patients with platelets ≤50 x 109/L randomized 1:1 to receive 3mg once upto 7 days Oral recommendation is 3mg Q.D. with or without food for 7 days Results (Mulpleta vs PBO): In L-PLUS 1, No platelet transfusion (78% vs […]Read More
Shots: Trazimera is a biosimilar of Herceptin indicated for treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma The EC approval is based on the data including REFLECTION B327-02 clinical study showing similarity b/w Trazimera and original product in patient Trazimera has been studied in ~500 patients across 20 countries Click […]Read More
Shots: Nalpropion buys global commercialization rights of Orexigen’s Contrave a weight loss drug. Nalpropion is an investor group which includes Pernix Contrave has approx. 2.5 Mn prescription since 2014, presently, it is launched in 25 countries with expected launch in 13 countries in 2018 and has an US exclusivity till 2030 Pernix will have an […]Read More
Shots: AZEDRA radio therapeutic indicated to treat adult and pediatric patients ≥12yrs with iobenguane scan positive Has shown reduction rate in need of blood pressure medication and tumor size in patients for approved IV dose 555MBq/mL Approval was based on pivotal Ph 2 under SPA showing 17/68 (25%) ≥50% patients showed reduction in medication and […]Read More
Shots: Results of 2600 patients trial reported significant i.e. ≥50% reduction in migraine days with comparable safety and tolerability to PBO Aimovig works by blocking calcitonin gene-related peptide receptor (CGRP-R) which plays vital role in migraine Can be self-administered every four weeks with the Sure Click®️ auto injector pen, device commonly used for […]Read More
Shots: Under the expansion collaboration, new arm of assessment is added assessing BL-8040, Keytruda and chemo in 2L patient in COMBAT/KEYNOTE-202 study Results of Ph2a COMBAT study is expected in H2’18 as planned This study is assessing combination of BL-8040 & Keytruda in metastatic 1L+ patients Click here to read full press release/ article | Ref: Biolinerx […]Read More
Shots: The extension provides a better understanding to clinicians and initial funding discoveries, molecular analyses, design and conduct of samples for new discoveries in cancer Agreement defines that Dana has right to perform multiple clinical and preclinical trials adding in Lilly’s pipeline Evaluated compound ownership will remain under Lilly Click here to read full press […]Read More
Shots: U.S. FDA announces recalling of over 2,508 bottles of Metformin hydrochloride with an extended release tablets of 500 mg, packaged in a 500-count bottle Reason for recall is detection of a piece of rubber glove in one lot of tablets Extended release tablets are used to improve glycemic control in adults with type 2 […]Read More
Shots: ChemBio will be using its patented DPP® technology platform to test rapid HCV core antigen assay Parallely, FIND is conducting pilot studies in six countries to introduce novel algorithms and demonstrate the impact of HCV rapid diagnostics FIND plans to assess the outcomes of the feasibility studies in Dec’18 and fund one company for […]Read More
Shots: Imfinzi has been approved in unresectable PD-L1 expressing LA NSCLC patients treated with platinum-based CRT Approval is based post-hoc subgroup analyses by PD-L1 expression in addition to PFS & OS results of PACIFIC trial In 2018, AZ received recommendations for Stage III NSCLC US, Canada, Switzerland, India, and Japan based on PACIFIC trial Click here […]Read More
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