Efficacy News and Research

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Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Novartis today announced that the United States Food and Drug Administration approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

26 Feb 2016

Lilly announces CHMP positive opinion for ixekizumab for treatment of adults with plaque psoriasis

Eli Lilly and Company announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union who are candidates for systemic therapy.

26 Feb 2016

PharmaMar begins PM184 Phase II trial in advanced breast cancer patients

PharmaMar has announced the start of an open-label multi-centre two-stage Phase II trial with the anti-tumour drug PM184. The trial will be conducted in 10 European clinical centres and will include 106 patients. The trial will focus on patients with hormone-receptor positive, HER2-negative, locally advanced and/or metastatic breast cancer, who have experienced progression following earlier treatment with anthracyclines and taxanes.

26 Feb 2016

Medical community has unique role to play in determining future use of mitochondrial replacement techniques

There is a unique role for the United States medical community to play in determining the future application of, and ethically acceptable approach to, mitochondrial replacement techniques (MRTs), according to a commentary published online by the New England Journal of Medicine.

26 Feb 2016

Allergan receives FDA approval to market ACZONE (dapsone) Gel, 7.5% for acne treatment

Allergan plc, a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. Food and Drug Administration to market ACZONE (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older.

26 Feb 2016

Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that it has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration seeking approval for the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] to treat children under the age of 12 with hemophilia A and for use in surgical settings.

26 Feb 2016

Rigel begins fostamatinib Phase 2 trial for treatment of patients with autoimmune hemolytic anemia

Rigel Pharmaceuticals Inc. today announced that it has initiated a Phase 2 clinical trial to evaluate fostamatinib, its oral SYK inhibitor, as a potential treatment for autoimmune hemolytic anemia (AIHA).

25 Feb 2016

Moffitt researchers develop novel therapeutic strategy to keep resistant cells in check

Despite numerous advances in oncology since the War on Cancer began, many patients develop resistance to standard therapies and eventually relapse. Moffitt Cancer Center researchers hope to improve treatment outcomes with development of a novel therapeutic strategy, called adaptive therapy, which is based on evolutionary principals and aims to keep resistant cells in check by maintaining a population of chemo-sensitive cells.

25 Feb 2016

Researchers launch clinical trials to test novel cellular-immunotherapy to treat three types of blood cancer

Cancer immunology is based upon boosting the body's own immune system to vanquish malignancies. It is among the fastest growing areas of oncology research. Researchers at UC San Diego Moores Cancer Center have launched three clinical trials to test the safety and efficacy of a novel cellular-immunotherapy that uses modified T cells - one of the immune system's primary weapons - to treat three different types of blood cancer that often defy existing therapies.

24 Feb 2016

Immunotherapy emerges as promising strategy for treatment of brain tumors

For decades most cancers have been treated with a core standard of treatments that include surgery, radiation, and chemotherapy. Now, immunotherapy—a type of treatment that harnesses the patient's immune system to combat the disease—represents the future of cancer treatment, with its efficacy being demonstrated in even the most aggressive types of cancer.

24 Feb 2016

New research shows copper can destroy MRSA in touch contamination

New research from the University of Southampton shows that copper can destroy MRSA spread by touching and fingertip contamination of surfaces.

24 Feb 2016

SOM0226 (tolcapone) drug could significantly improve pharmacological treatment of ATTR

Researchers at the Institute of Biotechnology and Biomedicine, Universitat Autònoma de Barcelona (IBB-UAB), in collaboration with the biopharmaceutical company SOM Biotech, located in the Barcelona Science Park (PCB), have published, in Nature Communications, the results of a drug repositioning study in which they describe a powerful drug, SOM0226 (tolcapone) that could significantly improve the pharmacological treatment of familial transthyretin amyloidosis (ATTR).

24 Feb 2016

First patient dosed in Novan's Phase 3 program to evaluate efficacy of SB204 Gel in treatment of acne

Novan, Inc. today announced that the first patient has been dosed in its Phase 3 program to evaluate the efficacy and safety of its topical nitric oxide product candidate SB204 Gel in the treatment of acne vulgaris ("acne"). The Company is running two identically designed Phase 3 pivotal trials in parallel and expects to report top-line results in the first half of 2017.

23 Feb 2016

Boston Scientific gets FDA approval for ACUITY X4 Quadripolar Left Ventricular leads

Boston Scientific has received U.S. Food and Drug Administration approval for the ACUITY X4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market.

23 Feb 2016

Dapivirine ring can help prevent HIV-1 infection in women

In an important scientific achievement for women's health, two large Phase III clinical trials -- The Ring Study and ASPIRE -- have shown that a monthly vaginal ring containing the antiretroviral drug (ARV) dapivirine can safely help prevent HIV-1 infection in women.

23 Feb 2016

Study identifies new mechanism for controlling HIV replication

Researchers at University of California, San Diego School of Medicine have discovered that HIV infection of human immune cells triggers a massive increase in methylation, a chemical modification, to both human and viral RNA, aiding replication of the virus.

23 Feb 2016

Regulus reports net loss of $7.2 million for fourth quarter 2015

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the fourth quarter and full-year ended December 31, 2015 and provided a summary of recent corporate highlights.

23 Feb 2016

Efficacy News and Research

Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Lilly announces CHMP positive opinion for ixekizumab for treatment of adults with plaque psoriasis

PharmaMar begins PM184 Phase II trial in advanced breast cancer patients

Medical community has unique role to play in determining future use of mitochondrial replacement techniques

Allergan receives FDA approval to market ACZONE (dapsone) Gel, 7.5% for acne treatment

Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Rigel begins fostamatinib Phase 2 trial for treatment of patients with autoimmune hemolytic anemia

Moffitt researchers develop novel therapeutic strategy to keep resistant cells in check

Researchers launch clinical trials to test novel cellular-immunotherapy to treat three types of blood cancer

Immunotherapy emerges as promising strategy for treatment of brain tumors

New research shows copper can destroy MRSA in touch contamination

SOM0226 (tolcapone) drug could significantly improve pharmacological treatment of ATTR

First patient dosed in Novan's Phase 3 program to evaluate efficacy of SB204 Gel in treatment of acne

Boston Scientific gets FDA approval for ACUITY X4 Quadripolar Left Ventricular leads

Dapivirine ring can help prevent HIV-1 infection in women

Study identifies new mechanism for controlling HIV replication

Regulus reports net loss of $7.2 million for fourth quarter 2015

ReCor gets FDA IDE approval to evaluate ReCor Paradise Renal Denervation System in patients with hypertension

Differences in patient education level may compromise safety, efficacy of anticoagulants

Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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