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The sNDA for the 72 mcg dose of linaclotide is based on efficacy and safety data from a double-blind, placebo-controlled Phase III clinical trial of 1,223 adult patients

The Phase 1 trial will be conducted in normal healthy volunteers. Initiation of this trial is based on encouraging pre-clinical results, including data presented last year at the

On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) in partnership with Valeant for

Isavuconazole is an intravenous and oral triazole antifungal indicated for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is

The company said its decision was based on evidence of tumour-inhibiting activity from early pre-clinical trials with the technology. GBM accounts for 16% of all diagnosed brain cancers

Afferent develops therapeutic candidates targeting the P2X3 receptor to treat common, poorly-managed, neurogenic conditions. The agreement gives Merck access to Afferent’s lead investigational candidate, AF-219, which is a

South African generic-drugs maker Aspen will also pay AstraZeneca royalties and about $250m in additional sales-based installments in the next two years. AstraZeneca’s anaesthetics portfolio includes five local

Lion Biotechnologies received gross proceeds of $100m, before paying the placement agents’ fees and estimated offering expenses payable by the Company. t the closing, the Company issued 9,684,000

The P2MC technology allows for the efficient, reproducible and chemically defined differentiation of pluripotent cells into skeletal muscle stem cells, also known as satellite cells. The agreement will