Saturday, February 16, 2019

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...

Isofol Initiates Pivotal Phase III Clinical Trial of Arfolitixorin for Metastatic Colorectal Cancer

Sweden-based Isofol Medical has initiated their pivotal Phase III clinical trial, called the ISO-CC-007 study, for the treatment of first-line (initial) metastatic colorectal cancer (mCRC). Arfolitixorin is a new drug candidate primarily developed to increase the efficacy of the cytotoxic agent 5‑fluorouracil (5-FU) in the treatment of patients with advanced colorectal cancer and as a rescue drug after high-dose methotrexate...

Daiichi Sankyo to Colaborate with Merck KGaA and Pfizer in Development of Trastuzumab Deruxtecan

This week Daiichi Sankyo confirmed a clinical research collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate trastuzumab deruxtecan*, an antibody-drug conjugate or ADC also known as DS-8201, in combination with avelumab (Bavencio®; EMD Serono/Pfizer), a human anti-programmed death ligand-1 (PD-L1) antibody, and a novel, investigational DNA damage response (DDR) inhibitor in patients with human epidermal growth factor...

Executives from American Express and J.P. Morgan Join St. Baldrick’s Foundation ‘s Board

The St. Baldrick's Foundation, the largest private funder of some of the most brilliant (clinical) research in childhood cancer, has added two new members to its board of directors. The new members, Jyoti Rai, Sr. Vice President of Global Talent, Leadership and Learning at American Express and Thomas Selquist, Managing Director at J.P. Morgan Private Bank, are expected to help...

Phase Ib/II Data of Durvalumab Plus Danvatirsen Shows Promise in Head and Neck Cancer

New clinical and safety results from a phase Ib/II trial in recurrent metastatic head and neck cancer, presented at the annual meeting of the European Society for Medical Oncology - ESMO 2018, shows that danvatirsen (formerly known as IONIS-STAT3-2.5Rx and also known as AZD9150), a Generation 2.5 antisense therapy targeting signal transducer and activator of transcription 3 (STAT3) being...

Novartis Plans to Acquire Endocyte to Expand Expertise in Radiopharmaceuticals

Earlier this month Swiss-based Novartis announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. The planned merger will expand Novartis' expertise in radiopharmaceuticals and build on commitment to transformational therapeutic platforms. Targeted therapies Endocyte uses drug conjugation technology to develop targeted therapies with companion...

NanoValent Receives NIH SBIR Funding for Antibody-conjugated Nanoparticle Technology

The National Institute of Health's (NIH) Small Business Innovation Research (SBIR) Program has confirmed that it has awarded first year funding for two separate projects being developed by NanoValent Pharmaceuticals, a development-stage pharmaceutical company advancing targeted antibody-drug conjugate (ADC) like, lipid based therapeutics. The two grants, totaling just under US $ 4 million, are expected to help NanoValent Pharmaceuticals to...

Study Shows Trade and Patent Changes Could Increase Healthcare Cost by $100bn Over the Next 5-years

In the second part of its 2018 annual report, CPhI Worldwide, the world’s largest pharma event taking place later this year in Madrid, Spain, Dilip Shah, CEO of Vision Consulting Group, and Bikash Chatterjee, President and Chief Science Officer at Pharmatech Associates review the impact of IPRs and trade agreements and regulatory divergence respectively, suggesting the implications of both could...

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