Tags : Treat

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19

Shots: SK bioscience signs a development and supply agreement for Novavax’ NVX-CoV2373 to supply it globally including the COVAX facility. SK bioscience will manufacture the vaccine antigen component for use in the final drug product SK bioscience will utilize its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at […]Read More

Gilead Reports NDA Submission to the US FDA for Veklury

Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, […]Read More

Lupin and SunPharma Launch Generic Favipiravir to Treat Mild to

Shots: Lupin has launched favipiravir in India under the brand name ‘Covihalt’ for the treatment of mild to moderate COVID-19 Covihalt will be available as 200mg tablets in the form of a strip of 10 tablets, priced at $0.65 (₹49/tablet) and has received DCGI authorization for emergency use Additionally, SunPharma has launched antiviral drug favipiravir […]Read More

LEO Pharma Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions […]Read More

AstraZeneca Signs a License Agreement with Redx Pharma for RXC006

Shots: Redx to receive $17M in early payment by the time of successful commencement of a P-I study, $360M as development, a regulatory and commercial milestone along with royalties on sales of the RXC006 AstraZeneca to get an exclusive global license to further develop & commercialize RXC006 targeting fibrotic diseases including IPF Redx continues to […]Read More

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to

Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical […]Read More