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Bristol-Myers Squibb and Celgene Merge

Bristol-Myers Squibb Company (headquartered in New York, New York) and Celgene Corporation (headquartered in Summit, New Jersey) have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and...

Rakuten Aspyrian Raises US $284 Million Series C Financing; Develops Photoimmunotherapy Platform

Privately funded clinical stage biotechnology company Rakuten Aspyrian has raised an additional $134 million in a second tranche of its Series C financing, bringing the total amount raised to $284 million. New investors include the SBI Group, Japan and Rakuten. As a result, Rakuten Aspyrian has raised approximately US $ 372 million in equity since the company's founding in...

Daiichi Sankyo Out-Licenses Investigational Agent DS-6051 to AnHeart Therapeutics

Daiichi Sankyo and AnHeart Therapeutics, a clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of innovative medicines, have entered into a worldwide exclusive license agreement to out-license DS-6051, an investigational selective ROS1/NTRK inhibitor, currently in Phase I development for the treatment of patients harboring either a ROS1 or NTRK fusion gene and neuroendocrine tumors. The trials are being...

Phase III AGENT Trial Enrolls First Metastatic Colorectal Cancer Patient

A first patient has been enrolled in the pivotal Phase III AGENT clinical study designed to evaluate arfolitixorin (Modufolin®; Isofol Medical) for the treatment of metastatic colorectal cancer (mCRC). The AGENT trial (NCT03750786) is a randomized, controlled, multi-center study with blinded independent review of the tumor response and is expected to enroll approximately 440 mCRC patients, who are at least...

Gilteritinib Available for Prescription in the United States for Adults with Acute Myeloid Leukemia

Gilteritinib (Xospata®; Astellas Pharma) is now available for prescription in the United States for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. An oral monotherapy, gilteritinib is the first and only FLT3-targeting agent approved by the U.S. Food and Drug...

FDA Approves Larotrectinib – the First Tumor-agnostic Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for larotrectinib (Vitrakvi® ; Bayer), also know as LOXO-101/ARRY-470 to Loxo Oncology. The novel, anticancer drug is a treatment for adult and pediatric patients whose cancers have a specific genetic biomarker across different types of tumors rather than the location in the body where the tumor originated. This...

Glasdegib Approved in Newly-Diagnosed AML Patients for Whom Intensive Chemotherapy is Not an Option

The U.S. Food and Drug Administration (FDA) has approved glasdegib, also known as PF-04449913 (Daurismo™; Pfizer), a once-daily oral smoothened (SMO) inhibitor for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. Acute myeloid leukemia (AML) is the most common type of...

FDA Grants Accelerated Approval for Venetoclax in Newly-Diagnosed Acute Myeloid Leukemia Patients

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to venetoclax (Venclexta®; Genentech/Roche and Abbvie), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people with newly-diagnosed Acute Myeloid Leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting...

European Commission Approves Pegfilgrastim Biosimilar Pelmeg

The European Commission has granted approval for the use of Pelmeg®, also known as B12019, (pegfilgrastim biosimilar) as a treatment for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy. The approved drug is a biosimilar medicinal product and highly similar to the reference product Neulasta® (pegfilgrastim; Amgen), which...

Australian Kazia Therapeutics Presents ‘Trial in Progress’ Data for Glioblastoma Study

Results for GDC-0084, an investigational drug being being developed by Australian- based and oncology-focused Kazia Therapeutics, were presented during the annual meeting of the Society for Neuro-Oncology (SNO), held in in New Orleans, LA November 16 - 18, 2018. The investigational agent is currently in human trials for the treatment of patients with glioblastoma, the most common and most aggressive...

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