Shots: The NICE recommendation is based on P-III APeX-2 trial evaluating Orladeyo vs PBO in adult & pediatric patients aged ≥12yrs. with HAE attacks The trial met its 1EPs i.e., reduction in HAE attacks @24wks. & sustained through 96wks. with an 80% reduction in patients with mean HAE attack rate/mos. @ 25-96wks. The therapy was […]Read More
Shots: The companies collaborated to evaluate Hookipa’s HB-200 (arenaviral immunotherapeutic) + Merck’s Keytruda (anti-PD-1 therapy) in a P-II trial for patients with advanced HNSCC, based on an ongoing P-I/II trial of HB-200 for advanced HPV16+ cancers patients HB-201 monothx. showed an ORR (18%), m-PFS (3.45mos.) in heavily pretreated head & neck cancer patients. Preliminary data […]Read More
Shots: The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in study period & […]Read More
Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator, m-DoR (17.5mos.), m-OS (24mos.), and m-PFS (7.3mos.) as per IRC Exkivity is a TKI inhibitor […]Read More
In an interview with PharmaShots, Dr. Dale Christensen, Ph.D., Director of Clinical Development at TFF Pharmaceuticals shared his views on the preliminary data from the P-I trial of inhalable tacrolimus powder formulation for Lung Transplant & its TFF technology Shots: TFF has developed an inhalable tacrolimus powder formulation that can be delivered directly to the […]Read More
Shots: The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 & 20 patients with R/R MZL who received at least 1 anti-CD20-based regimen Both trial demonstrated ORR (56% & 80%), CR rate (20% & 20%) based on assessment using CT […]Read More
Shots: The companies collaborated to evaluate IO’s IO102-IO103 + MSD’s Keytruda vs Keytruda alone in the P-III trial for patients with previously untreated unresectable or MM. Biomarker studies will also be conducted while IO will sponsor the trial & MSD will provide Keytruda The P-I/II trial of combination therapy in 30 patients with the same […]Read More
Shots: AbCellera acquires TetraGenetics in an all-cash transaction that includes up front, milestones based on the achievement of technical milestones related to the development of therapeutics The acquisition will combine TetraGenetics’ capabilities with AbCellera’s technology to provides an optimized protein source for AbCellera’s Abs discovery across a range of therapeutic areas. The technology has the […]Read More
Shots: The companies collaborated to launch a digital companion app i.e., Brisa to treat patients with MS. The app will be offered free of charge for users and motivates to change lifestyle in the long term The Brisa app is designed as an individual digital companion & will collect daily health data like activity, sleep, […]Read More
Shots: The P-II/III study evaluates opaganib +SoC vs PBO + SoC in a ratio (1:1) in 475 patients with COVID-19 pneumonia requiring hospitalization & treatment with supplemental oxygen The preliminary data showed that the study did not meet its 1EPs while efficacy EPs showed consistent trends. The therapy demonstrated good tolerability with balanced AEs & […]Read More
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