Medigene AG, a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, announces the grant of US patent US9,341,617B2. The patent, with an expected life-span until 2030, claims a method for the identification of antigens recognized by CD4+ T cells, including tumor infiltrating CD4+ T cells.
Eiger BioPharmaceuticals, Inc., announced that the first patient in the phase 2 ULTRA study was dosed at Stanford University. The ULTRA study will evaluate the effects of ubenimex in patients with secondary lymphedema of the lower limb(s) who are optimized on physical therapies. Physical therapies, such as compression garments and bandaging, reflect the current standard of care for lymphedema. Ubenimex is a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase (LTA4H), which blocks the production of leukotriene B4 (LTB4), an inflammatory mediator implicated in lymphedema.
Sun Pharmaceutical Industries and Almirall signed a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.
RPG Life Sciences acquired seven prescriptions brands from Sun Pharmaceuticals, largest pharmaceutical industry from India in 41 crores.
The U.S. Federal Trade Commission (FTC) has nodded the proposed consent order in connection with the pending acquisition of Allergan’s generics business (“Actavis Generics”) by Teva Pharmaceutical Industries Ltd. With the acceptance of the proposed consent order, Teva has satisfied the regulatory approval requirements under the purchase agreement to complete the acquisition of Actavis Generics.
Faron Pharmaceuticals Ltd, a clinical stage biopharmaceutical company, and Abzena plc, a life sciences group providing services and technologies to enable development and manufacture of biopharmaceutical products, announce that they have entered into an agreement whereby Abzena will manufacture Clevegen®, a novel therapeutic antibody being developed by Faron to reduce immune suppression in cancer. Clevegen may also have the potential to be used in other situations where there is an inadequate immune response, such as in chronic infections or during vaccination.
Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the US Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's product candidate, EVK-001 (metoclopramide nasal spray). A request for proprietary name review for Gimoti will be included if and when Evoke submits a New Drug Application (NDA) for the product candidate.
GenVec, Inc., a clinical-stage gene delivery company, announced that it was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
AbbVie and Bristol-Myers Squibb Company announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).
Allergan plc, a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI (eluxadoline) in the European Union. TRUBERZI is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. In two pivotal trials, TRUBERZI significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months. TRUBERZI was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain.