Shots: The FDA has approved Patient-Specific Talus Spacer 3D-printed talus implant for humanitarian use. The FDA reviewed data through the HDE process Data supporting the safety of implant include results from 31 patients and 32 talus replacement surgeries with the implant. Post-operation @3yrs, pain decreased from “mod. to sev.” prior to surgery to “mild” post-surgery, […]Read More
Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best […]Read More
Shots: The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled 635 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans and who had rising serum PSA levels after initial prostate surgery or radiotherapy […]Read More
Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd) in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies The approval of q2w dosing regimen is based on P-III CANDOR study assessing […]Read More
Shots: The five therapies include Tabrecta (capmatinib) for advanced and recurrent unresectable NSCLC, Entresto (sacubitril valsartan sodium hydrate) for chronic HF, Mayzent (siponimod fumaric acid) for secondary PMS, Enerzair (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and Atectura (indacaterol acetate, mometasone furoate) for different forms of asthma In 2020, Novartis has received seven approval in Japan […]Read More
Shots: The EC has approved the Viatris merger (a merger b/w Upjohn and Mylan) under EU merger regulations but the decision is conditional on the divestment of Mylan’s certain generic therapies EC ensures that the merger does not harm competition and preserves the competitive access to certain genericized therapies for national health services and the […]Read More
Shots: The Japan Ministry of Health, Labor and Welfare approves the evaluation of iPS cells in a clinical research for spinal cord injuries at Keio University in Tokyo, with expected onset in H1’2019 The study is will be conducted enrolling 4 adults with spinal cord injuries whose sensation and bodily mobility have been completely lost, […]Read More
Shots: The approval is based on the STML-401-0114 (NCT 02113982) study assessing immunophenotypic diagnostic CD123, CD4 & CD56 patients in treatment-naïve and previously-treated patients IV STML-401-0114 results: Elzonris(12 mcg/kg/day): ORR 90% (26/29); CR/CRc 72% (21/29); 45% of patients went for SCT post Elzonris treatment Elzonris is a CD123-targeted therapy indicate to treat adult and pediatric patients with […]Read More
Shots: Congo approves experimental Ebola treatments including Remdesivir by Gilead Sciences; ZMapp by Mapp Pharmaceutical; Favipiravir by Toyama and Regn3450, Regn3471, Regn3479 by Regeneron Pharmaceuticals Health authorities has approved these experimental treatments, as the Ebola epidemic continues to spread Total number of death are 59 and confirmed cases to 75 since last month, with […]Read More
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