Top Pharma News of the Week

All The Most Important Pharmaceutical News Stories Of The Week – January 2018 – Week #4

FDA Approves Addition of Overall Survival Data To KYPROLIS® (carfilzomib) Label

January 17, 2018

Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01).

Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

January 17, 2018

Novartis has announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review. In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT.

Kite Announces Clinical Collaboration to Evaluate Investigational Combination of Yescarta™ (Axicabtagene Ciloleucel) and Pfizer’s Utomilumab in Large B-Cell Lymphoma

January 18, 2018

Kite, a Gilead Company, has announced that it has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the investigational combination of Yescarta™ (axicabtagene ciloleucel) and Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients with refractory large B-cell lymphoma. A multi-center Phase 1/2 study sponsored by Kite is expected to begin in 2018. The results of this study will be used to evaluate options for further development of this combination, or similar combinations between Kite’s engineered T cell products and utomilumab.

Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars

January 18, 2018

Sandoz, a Novartis division and a global leader in biosimilars, has announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU, while Biocon will lead commercialization in Rest of the World.

Sanofi to Acquire Bioverativ for $11.6 Billion

January 22, 2018

Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis).  The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors.

Celgene Corporation to Acquire Juno Therapeutics, Inc., Advancing Global Leadership in Cellular Immunotherapy

January 22, 2018

Celgene Corporation and Juno Therapeutics, Inc. have announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Juno. Under the terms of the merger agreement, Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies.

Biocryst Pharmaceuticals and Idera Pharmaceuticals Announce Merger to Combine Capabilities to Serve More Patients with Rare Diseases

January 22, 2018

BioCryst Pharmaceuticals, Inc. and Idera Pharmaceuticals, Inc. have announced that they have signed a definitive merger agreement to form a new enterprise focused on the development and commercialization of medicines to serve more patients suffering from rare diseases.  The combined company will be renamed upon closing and will be led by Vincent Milano, CEO of Idera, who will also serve as a member of the Board. BioCryst Chairman, Robert Ingram, will be Chairman of the Board of the combined company and BioCryst CEO Jon P. Stonehouse will serve as a member of the Board of Directors.

Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell Transplant Recipients

Jan. 22, 2018

Astellas Pharma Inc. and Vical Incorporated have announced that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or secondary endpoints in the Phase 3 HELIOS clinical trial.

Top Pharma News of the Week last edit: 2018-01-23T18:21:49+00:00 da Luca

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