- Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint
July 5, 2017
Bristol-Myers Squibb Company has announced that a Phase 3 study evaluating Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint at a planned interim analysis, demonstrating superior recurrence-free survival (RFS) in patients receiving Opdivo compared to Yervoy.
- Merck Provides Further Update on Three Multiple Myeloma Studies Evaluating KEYTRUDA® (pembrolizumab) in Combination with Pomalidomide or Lenalidomide
July 5, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. This decision follows a review of data by the Data Monitoring Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enrollment, as announced on June 12, 2017. The FDA has determined that the data available at the present time indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.
- Celgene Corporation Enters Into Global Strategic Immuno-Oncology Collaboration with BeiGene to Advance PD-1 Inhibitor Program for Solid Tumor Cancers
Jul 5, 2017
Celgene Corporation and BeiGene, Ltd. entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally and for solid tumors in Asia (with the exception of Japan). BeiGene will acquire Celgene’s commercial operations in China and gain an exclusive license to commercialize Celgene’s approved therapies in China – ABRAXANE®, REVLIMID® and VIDAZA®.
- Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis
July 6, 2017
Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® * (ustekinumab) in psoriasis. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis- one of the most difficult-to-treat forms of psoriasis, which affects approximately 60 million people worldwide. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx.
- Bristol-Myers Squibb’s ORENCIA (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis (PsA) in Adults
July 6, 2017
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA), a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. ORENCIA is approved and available in both intravenous and subcutaneous (SC) injection formulations.
July 6, 2017
Eli Lilly and Company and Purdue University have announced a strategic collaboration to conduct life science research. The five-year agreement, where Lilly will provide up to $52 million, marks Purdue’s largest strategic collaboration with a single company. The initial research focus areas include:
- Developing improved delivery of injectable medicines with the goals of reducing pain, decreasing the number of injections, and enabling better patient compliance and overall health.
- Developing predictive models for clinical success that reduce risks associated with investing in drug development and more effectively predict the outcome of new therapies in humans.
- Merck to Present New Data from Clinical Trials Evaluating ISENTRESS® HD (raltegravir) and Investigational HIV Therapies Doravirine and MK-8591 at IAS 2017
July 6, 2017
Merck has announced that new data from the company’s HIV portfolio and pipeline are scheduled to be presented at the 9th IAS Conference on HIV Science (IAS 2017). Presentations include late-breaker abstracts from two Phase 3 pivotal clinical trials – Week 96 data from ONCEMRK, a study evaluating once-daily ISENTRESS ® HD (raltegravir) in combination with other antiretroviral agents in previously untreated adult patients with HIV-1 infection, and Week 48 data from DRIVE-AHEAD, a study evaluating doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) as part of a fixed dose regimen containing doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) compared to a regimen containing efavirenz (EFV), emtricitabine (FTC), and TDF in previously untreated adult patients with HIV-1 infection.
July 10, 2017
Takeda Pharmaceutical Company and Axcelead Drug Discovery Partners, Inc. have announced the start of operations for AXCELEAD occurred on July 1, 2017. AXCELEAD is the receiving company to which Takeda transferred a part of its research business, announced on May 15, 2017. AXCELEAD aims to bridge basic and applied clinical research, from exploratory research to optimizing candidate compounds.