Tags : study

Celltrion Reports Results of Regdanvimab (CT-P59) in Pre-Clinical Study Against

Tuba Khan April 30, 2021

Shots: The preclinical results have demonstrated that CT-P59 has neutralizing effect against the South African variant and showed a reduction in viral load of SARS-CoV-2 and in binding affinity against RBD in the three mutations of the South African variant The company has completed patient enrolment of 1,300 people in an ongoing P- III trial […]Read More

Clinical Trials

I-Mab Reports Results of Olamkicept (TJ301) in P-II Study for

Tuba Khan April 27, 2021

Shots: The P-II study involves assessing Olamkicept (300/600mg, q2w, IV) vs PBO in 91 patients in a ratio (1:1:1) who had active UC with a full Mayo score ≥5, a rectal bleeding subscore ≥1, an endoscopy subscore ≥2, and had an inadequate response with conventional UC therapy The study met its 1EPs & 2EPs, demonstrating […]Read More

Clinical Trials

Novo Nordisk to Initiate P-IIIa Study for Oral Semaglutide to

Tuba Khan April 22, 2021

Shots: The company plan to initiate a pivotal P-IIIa program to assess the efficacy and safety of oral semaglutide (50mg) vs PBO in ~1000 people with obesity or overweight with comorbidities for 68wks. The initiation follows the completion of the STEP P-IIIa clinical program with semaglutide (2.4mg, qw, SC). The study is expected to initiate […]Read More

Clinical Trials COVID-19

Eli Lilly along with VIR and GSK Report Results of

Tuba Khan March 30, 2021

Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 in the outpatient setting across the US and Puerto Rico Results: The dual regimen met its 1EPs i.e. 70% relative reduction in persistently high viral load (> 5.27; cycle threshold […]Read More

Clinical Trials

Pfizer and Myovant Report Results of Relugolix Combination Therapy in

Tuba Khan March 25, 2021

Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss < 80 mL) (78.4% vs 15.1%). The study met 2EPs […]Read More

Clinical Trials

Johnson & Johnson Report Long-Term Data of Tremfya (guselkumab) in

Tuba Khan March 17, 2021

Shots: The P-III DISCOVER-2a study involves assessing Tremfya (q4w/ q8w, SC) in bio-naïve patients with active PsA Results: @100wks. complete skin clearance (PASI 100) (59 %/53%); improvement in joint symptoms (ACR 20) (76%/74%). The findings confirmed that the robust efficacy of Tremfya demonstrated in patients @24wks. on physical function, physical aspects of health-related QoL, and […]Read More

Clinical Trials

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study

Tuba Khan March 15, 2021

Shots: The P-II study involves assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging The study met its 1EPs, showed a slowing of decline by 32% @76wks. as measured by the iADRS. The secondary […]Read More

Clinical Trials

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary

Tuba Khan March 11, 2021

Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet its 1EPs i.e. improvement in time to hospital discharge up to day28 and failed to meet its 2EPs compared to Veklury alone. The findings will […]Read More

Clinical Trials

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in

Tuba Khan March 5, 2021

Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs @36wks. and demonstrated significant improvement […]Read More

COVID-19 Regulatory

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273

Tuba Khan March 5, 2021

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment […]Read More

Calliditas Signs a License Agreement with STADA to Commercialize Specialty Therapy for the Treatment of IgA Nephropathy in EU

AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe Products in US

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Synaffix Signs a License Agreement with ProfoundBio for ADC Technologies

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Mabpharm’s Biobetter (CMAB008) for Infliximab Receives NMPA’s Approval in China

Celltrion Collaborates with Inhalon to Develop Regdanvimab (CT-P59) for the Treatment of COVID-19 at Home

Hologic Receives CE Mark to Use Saliva Samples with Aptima SARS-CoV-2 Test in EU

AstraZeneca’s Bydureon BCise (exenatide extended-release) Receives the US FDA’s Approval for the Treatment of Type2 Diabetes

Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval for the Treatment of Advanced Endometrial Carcinoma

NGM Reports Completion of Patient Enrollment in P-II CATALINA Study of NGM621 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

IM Reports Results of IMT-002 in P-Ib MAD Trial for the Treatment of Type 1 Diabetes

Tags : study

Celltrion Reports Results of Regdanvimab (CT-P59) in Pre-Clinical Study Against

I-Mab Reports Results of Olamkicept (TJ301) in P-II Study for

Novo Nordisk to Initiate P-IIIa Study for Oral Semaglutide to

Eli Lilly along with VIR and GSK Report Results of

Pfizer and Myovant Report Results of Relugolix Combination Therapy in

Johnson & Johnson Report Long-Term Data of Tremfya (guselkumab) in

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273

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PharmaShots Weekly Snapshots (July 19 – 23, 2021)

AstraZeneca’s Bydureon BCise (exenatide extended-release) Receives the US FDA’s Approval for the Treatment of Type2 Diabetes

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Tags : study

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