Shots: The expanded label approval is based on P-III KEYNOTE-189 study results assessing Alimta + pembrolizumab + Pt-based CT vs Alimta + Pt-based CT +PBO in 616 patients with mnon-sq NSCLC, regardless of PD-L1 expression P-III KEYNOTE-189 results: mPFS (8.8 vs 4.9 mos.); ORR (48% vs 19%); CR (0.5% vs 0.5%); PR (47% vs 18%); […]Read More
Shots: The BCI application focuses on human auditory cortex for the reconstruction of unspoken thoughts into speech for patients have who lost their ability to speak due to stroke, injury, and disease such as ALS The technology includes vocoder, a computer algorithm used for interpreting brain activity will that connects a direct pathway with brain […]Read More
Shots: The BT designation is based on P-I/II and P-II results assessing four lots of V114 in healthy adults and infants, demonstrating non-inferiority data in patients FDA’s BT designation is granted to the drugs showing clinical improvement over a currently available therapy on at least one clinically significant endpoint with benefits of Priority Review and […]Read More
Janssen, J&J, Reports, Results, Erleada, apalutamide, P-III, TITAN Study, Metastatic Castration-Sensitive Prostate CancerRead More
Shots: The P-III CREAD-1 and 2 study involves assessing of Crenezumab vs PBO in 1500 patients with early AD with confirmed evidence of cerebral beta-amyloid pathology (CSF or amyloid PET) for a duration of two years The discontinuation process of trial is based on its unmet 1EPs results from baseline Clinical Dementia Rating-Sum of Boxes […]Read More
Shots: Post decision of UK moving out from EU with the announcement of Brexit in 2016, EMA initiated shifting of its headquarters (HQs) apart from UK. EMA decided to move its HQs to Amsterdam after voting from EU in Nov,2017 with the loss of 900 jobs in UK EMA officially lowered 28 countries flags on […]Read More
Shots: Voyager to receive $165M upfront including $115M in cash, $50M equity investment at $11.96/share and $1.7B milestones for its four gene therapy programs including VY-AADC & VY-FXN01. Additionally, Neurocrine to fund the two undisclosed gene therapy programs and Voyager to receive milestone and royalties on its WW sales Neurocrine to fund P-II/III & P-I […]Read More
Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study results: PANSS @6weeks (-19.3 vs -12.7); AEs (47.0% vs 51.1%); discontinued patients (5.7% vs 6.4%); improvement in CGI-S @6 weeks; well tolerated in patients Lurasidone (40/80 mg/day; flexible dose) is an antipsychotic […]Read More
Shots: The P-III TIDES study contains three parts assessing TAK-003 (0.5ml, SC) vs PBO in patients for the prevention of dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents, evaluating the efficacy, safety and immunogenicity The P-III study demonstrated well-tolerated, safe and efficacious results in […]Read More
Shots: The P-III OA study involves assessing of tanezumab (2.5mg/5mg, SC) vs PBO in 849 patients in the ratio (1:1:1) with moderate-to-severe OA pain of the knee or hip across EU and Japan for 24 wks. The study showed a meeting in all 1EPs improvement in pain, physical function with well-tolerated results and has shown […]Read More
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