The FDA has accepted for review Santarus and Pharming's Biologics License Application for Ruconest (INN conestat alfa) 50 IU/KG, a recombinant human C1 esterase inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema.
Gilead Sciences announced interim results from its Phase 2 Study 101-09 evaluating idelalisib, an oral PI3K delta inhibitor for the treatment of patients with indolent non-Hodgkin's lymphoma that is refractory to rituximab and to alkylating-agent containing chemotherapy. If approved it may provide a new treatment option to patients with few remaining conventional treatment options.
Pharmacyclics and Janssen R&D announced results from their Phase 2 MCL and DLBCL study stating that ibrutinib, an investigational BTK inhibitor, demonstrated efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL) or diffuse B-cell lymphoma (DLBCL).
Janssen Biotech announced data from three Phase 3 trials, GO-FORWARD, GO-BEFORE, and GO-AFTER evaluating Simponi 50mg administered subcutaneously once every four weeks in the treatment of moderately to severely active rheumatoid arthritis.
AMG 386 plus paclitaxel met its primary endpoint of progression-free survival in its Phase 3 TRINOVA-1 trial for recurrent ovarian cancer.
Celgene announced positive long-term data from PALACE 1, the first of four Phase 3 studies evaluating patients with psoriatic arthritis.
Results from a Phase 3b head-to-head study showed that abatacept had comparable efficacy to adalimumab in patients with active moderate-to-severe rheumatoid arthritis.
Advaxis announced it has submitted an orphan drug application for ADXS-HPV in the treatment of human papillomavirus-associated head and neck cancer.
NanoViricides has submitted an Orphan Drug Application to the FDA for DengueCide, a nanoviricide for the treatment of dengue and dengue hemorrhagic fever.
The FDA has issued a Complete Response Letter informing AVEO Oncology that its New Drug Application for tivozanib for the treatment of patients with advanced renal cell carcinoma will not be approved in its present form.
The FDA has granted priority review for Gildead's NDA for sofosbuvir, a once daily oral nucleotide analogue inhibitor for the treatment of chronic HCV infection.
Regeneron and Bayer Healthcare announced positive results from their Phase 3 MYRROR study evaluating the use of Eylea Injection in myopic choroidal neovascularization.
The FDA has accepted and granted priority review for Bristol-Myers Squibb's and AstraZeneca's Biologics License Application for metreleptin for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy.
Adding ganetespib to docetaxel in salvage therapy prolongs OS compared to docetaxel alone among patients diagnosed with advanced adenocarcinoma lung cancer, research presented at ASCO 2013 has found.
The FDA has issued a Complete Response Letter to the New Drug Application for Sefelsa, an investigational oral twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause.