LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: […]Read More
Shots: The P-III ECZTRA 6 trial evaluates the efficacy & safety of tralokinumab (150/300mg, q2w) as monothx. vs PBO in 301 patients aged 12-17yrs. with mod. to sev. AD who were candidates for systemic therapy The trial met its 1EPs & 2EPs i.e., @16wks., patients achieved a clinical response & achieved clear or almost clear […]Read More
Shots: Marinomed to receive $2M up front & is eligible to receive milestones upon achievement of development, regulatory & commercial milestones along with royalties on sales of Budesolv in Greater China Luoxin will co-develop Budesolv, a new formulation of the glucocorticoid budesonide in China & will lead the clinical development & obtain the Chinese marketing […]Read More
Shots: The P-III PRIME2 trial evaluates Dupixent vs PBO with/out topical treatments in 160 adults with PN inadequately controlled with topical prescription therapies The trial met its 1EPs and all key 2EPs i.e., patients experienced a reduction in itch from baseline (37% vs 22%) @12wks.; reduction in itch from baseline (58% vs 20%) & patients […]Read More
Shots: The P-III VANISH-303 evaluates ibrexafungerp vs PBO in patients with VVC & P-II DOVE studies assess ibrexafungerp vs fluconazole for the same indication. The results were published in America’s Clinical Infectious Diseases In the P-III study, the therapy was superior in completely resolving signs & symptoms of VVC @10 Day (50.5% vs 28.6%); superior […]Read More
Shots: Genovis to receive up front for an exclusive license to Xork & is eligible to receive development & sales-based milestones along with royalties on sales globally & holds the rights for research, preclinical, diagnostic & other non-therapeutic applications of Xork The collaboration will utilize Genovis’ IgG protease, IdeXork (Xork & Selecta’s ImmTOR platform for […]Read More
Shots: Incyte will lead the development, manufacture, and supply of both products. ST will be responsible for the regulatory, distribution, and local marketing related activities in Australia, New Zealand & Singapore Tafasitamab + lenalidomide is approved in the US & EU to treat adult patients with r/r DLBCL who are not eligible for ASCT Pemigatinib […]Read More
The US FDA has approved 5 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 55 novel products in 2021 Additionally, last year in 2020, the US FDA […]Read More
Shots: The P-III trial evaluates a booster dose of COVID-19 vaccine (30µg) in a ratio (1:1) in 10000+ individuals aged ≥16yrs. with COVID-19 who previously received the primary two-dose series of vaccine The results showed vaccine efficacy of 95.6% compared to a non-boosted group, median time b/w second & booster dose was ~11mos., symptomatic COVID-19 […]Read More
Shots: The CDC’s ACIP has voted to recommend Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) to protect adults against invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes The ACIP has recommended one dose of Prevnar 20 for adults aged ≥65 & for ≥19yrs. with risk conditions who have not previously received a pneumococcal […]Read More
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