FDA rejects PTC Therapeutics’ application for Duchenne drug
The drug regulator said that an additional clinical trial would be required to establish the efficacy of the protein restoration therapy ataluren for the rare and fatal genetic
The drug regulator said that an additional clinical trial would be required to establish the efficacy of the protein restoration therapy ataluren for the rare and fatal genetic
Under the deal, the companies will study a portfolio of antibody targets, of which AbbVie will have global development and commercial rights to two targets. Alector has developed
The company has taken the decision based on three proof-of-concept studies, which does not show clinically meaningful efficacy results. The studies comprised of Phase 1 study in healthy
Both existing and new investors, including Auven Therapeutics, Redmile, the Wild Family Office and AstraZeneca oversubscribed and supported the financing. ADCT develops antibody drug conjugates (ADCs) that target
The firm has decided to terminate the trials based on the recommendation of the data monitoring committee, which evaluated overall benefit/risk during a recent interim futility analysis. Celgene
The non-live, recombinant subunit vaccine has been indicated to be given intramuscularly in two doses. Shingrix, which combines glycoprotein E antigen with the AS01B adjuvant system, works by
The FDA approval for Yescarta includes patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL resulting
Fremanezumab, which is an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody, is intended for the preventive treatment of migraine. The CGRP ligand is considered to be a well-validated target
The partnership will use the HemoShear’s Reveal-Tx proprietary disease modeling platform, which applies principles of physiological blood flow to tissue derived from patients. The platform will help drug
Impax Laboratories is a specialty pharmaceutical company, based in California while Amneal is a generic pharmaceutical manufacturer based in Bridgewater, New Jersey. Post merger, Amneal shareholders will own