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FDA approves NDA filing for ibrutinib inhibitor in two B-cell malignancies

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

29 Aug 2013

Study shows ABL kinases have enhanced expression and activity in CML

Chronic Myelogenous Leukemia (CML) is a cancer of the white blood cells that is most commonly found in adults and in the elderly. Its incidence has been estimated to be 1 to 2 in 100,000 people. CML was the first cancer to be associated with a genetic abnormality, known as the Philadelphia Chromosome, which 95% of all CML patients carry in their cells.

28 Aug 2013

FDA grants Priority Review designation to sNDA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced that the U.S. Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

27 Aug 2013

Pazopanib drug shows improved quality of life and safety in metastatic kidney cancer patients

Two oral targeted drugs approved for metastatic kidney cancer worked equally well, but one proved superior in tolerability, according to results of a large international clinical trial led by researchers at Dana-Farber Cancer Institute.

22 Aug 2013

X-linked methyl-CpG protein may be potential target for treatment of Parkinson's

X-linked methyl-CpG binding protein 2 plays important role in the regulation of neuronal development, proliferation and maturation, and synaptic regeneration and apoptosis.

13 Aug 2013

ImmunoGen reports net loss of $21.9 million in Q4 2013

ImmunoGen, Inc., a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload antibody-drug conjugate technology, today reported financial results for the three-month period and fiscal year ended June 30, 2013. ImmunoGen also provided guidance for its 2014 fiscal year and an update on the Company.

2 Aug 2013

Phase III trial shows afatinib offers clinical benefit to patients with EGFR mutation positive NSCLC

Afatinib has a novel mode of action and data has shown that it offers a clinical benefit to patients with a specific type of lung cancer, which we are further investigating in the extensive LUX-Lung clinical trial programme.

1 Aug 2013

Genistein derived from soybeans shows promise in inhibiting HIV infection

A compound found in soybeans may become an effective HIV treatment without the drug resistance issues faced by current therapies, according to new research by George Mason University researchers.

30 Jul 2013

Protein on surface of human breast tumour cells may serve as drug target for breast cancer

Scientists have identified higher levels of a receptor protein found on the surface of human breast tumour cells that may serve as a new drug target for the treatment of breast cancer.

19 Jul 2013

Kolltan signs research agreement with CHOP for novel therapeutic approaches for neuroblastoma

Kolltan Pharmaceuticals, Inc., a privately held biopharmaceutical company, today announced a license and research agreement with The Children's Hospital of Philadelphia to commence a collaboration with Yaël Mossé, M.D, an internationally recognized clinician and scientist for her work studying the causes and novel therapeutic approaches for the treatment of children diagnosed with neuroblastoma.

18 Jul 2013

Quest Diagnostics completes sale of ibrutinib commercialization rights to Royalty Pharma

Quest Diagnostics Incorporated, the world's leading provider of diagnostic information services, announced today that it has completed the sale of its rights to royalties from commercialization of the drug candidate ibrutinib to Royalty Pharma, the industry leader in acquiring royalty interests in marketed and late stage biopharmaceutical products, for $485 million in cash.

From Quest Diagnostics 18 Jul 2013

Virginia Commonwealth University receives $1.8M grant to study biology of allergic disease

The National Institutes of Health has awarded Virginia Commonwealth University a grant totaling $1.8 million to study the biology of allergic disease - work which may one day point researchers to the development of therapies to fight asthma, allergy and inflammatory conditions such as rheumatoid arthritis, multiple sclerosis and heart disease.

18 Jul 2013

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

Advanced genetics technologies may help predict patient outcomes in people with ALL

New evidence suggests that using advanced genetics technologies to monitor for remaining cancer cells after treatment may soon become an effective tool to inform treatment decisions and ultimately predict patient outcomes for patients with a particularly aggressive form of acute lymphocytic leukemia (ALL).

10 Jul 2013

Pharmacyclics submits ibrutinib NDA to FDA for two B-cell malignancies

Pharmacyclics, Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for the investigational oral Bruton's tyrosine kinase inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.

10 Jul 2013

MerTK inhibition in leukocytes decreases tumor growth and metastasiss

The tyrosine kinase MerTK plays a prominent role in the body's immune response. MerTK signaling helps "calm" the body's first line of immunity, the macrophage, while it performs the routine duties - clearing cells that die and healing damaged tissue.

9 Jul 2013

ARIAD Pharmaceuticals' Iclusig gets EC marketing authorization for CML and Ph+ ALL treatment

ARIAD Pharmaceuticals, Inc. today announced that the European Commission has granted a marketing authorization for Iclusig (ponatinib) as an orphan medicinal product for two indications.

2 Jul 2013

Researchers use two new methods to detect levels of ALK protein expression in NSCLC

The implementation of personalized health care in cancer relies on the identification and characterization of cancer biomarkers and the availability of accurate detection systems and therapies for those biomarkers.

2 Jul 2013

Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and an application for marketing authorization to the European Medicines Agency for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

1 Jul 2013

Study: Pluripotent stem cell line-derived neurons survive and respond to cues in the primate brain

A team of researchers from Rush University, Yale University, the University of Colorado and the St. Kitts Biomedical Research Foundation transplanted human embryonic stem cells into primate laboratory animals modeled with Parkinson's disease and found "robust survival" of the cells after six weeks and indications that the cells were "well integrated" into the host animals.

29 Jun 2013