Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | […]Read More
Shots: The BTD is based on early and preliminary clinical data involves assessing TAK-994 for the treatment of EDS that may demonstrated substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients TAK-994 is being evaluated in an ongoing P-II TAK-994-1501 study while the completed data from study will be presented at a […]Read More
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe […]Read More
Shots: The P-III HELP OLE study evaluating the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5 yrs. Results: 87.4% mean reduction in attack rate compared to baseline & median reduction was 97.7%. Additionally, @70 day steady-state, attack rates were further reduced to a mean of 92.4% […]Read More
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]Read More
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation, Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure […]Read More
Shots: The P-III TIDES study involves assessing two doses of TAK-003 (0.5mL, SC on day 1 & 90) vs PBO to prevent laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 20,000+ children and adolescents Results: @36mos. after the second dose, 62.0% VE against VCD; 65.0% […]Read More
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR […]Read More
Shots: The P-I/II study involves assessing Mobocertinib (160mg, PO) in patients with EGFR Exon20 insertion+ mNSCLC who received prior Pt-based CT The results showed mobocertinib continued to demonstrate clinically meaningful benefit after over 1yr of follow up and will be presented at the ASCO. The updated results demonstrated an encouraging ORR (28%), DoR (17.5mos.), OS […]Read More
Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, who have received prior Pt-based CT. The anticipated PDUFA date is Oct 26, 2021 The NDA is based on a P-I/II study assessing mobocertinib (PO) in patients with mNSCLC. The […]Read More
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