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FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

9 Oct 2015

$Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study$

Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study

Osteoporosis, a disease of progressive bone loss, affects 70 percent of the U.S. population older than age 50: one in two women--and one in five men. These individuals are at risk for fragility fractures, a break that results from a fall, or occurs in the absence of obvious trauma, and most commonly seen in the wrist, the upper arm, the hip, and the spine.

9 Oct 2015

Immunovia and OHSU team up to validate, commercialize blood test for early diagnosis of pancreatic cancer

Immunovia AB and the Knight Cancer Institute at Oregon Health & Science University formed a collaboration to confirm, validate and commercialize a blood test for the early diagnosis of pancreatic cancer. The test called IMMray™ PanCan-d analyses a patient's immune system for early signs of disease. The collaboration will also enable researchers to explore biomarkers for a number of other cancer types.

9 Oct 2015

NanoString Technologies will donate to honor cancer survivors featured in its newest campaign

To honor six cancer survivors featured in its newest international ad campaign, NanoString Technologies, Inc. will donate $6,000 to the American Cancer Society. The “Dear Cancer Researcher” participants courageously shared their personal stories of triumph to help the biotechnology company launch its newest product, nCounter SPRINT™ Profiler, a system that gives researchers the tools and opportunity to think beyond current everyday practice.

From NanoString Technologies 9 Oct 2015

Research on investigational menopause drug wins first prize

Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced it received top honors for its research on investigational drug lasofoxifene at the 26th annual North American Menopause Society (NAMS) meeting in Las Vegas last week.

9 Oct 2015

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF).

8 Oct 2015

EMA completes review of proposed amendment to OncoGenex's Phase 3 AFFINITY trial protocol

OncoGenex Pharmaceuticals, Inc. announced today that the European Medicines Agency has completed its review of the proposed amendment to the company's Phase 3 AFFINITY protocol and statistical analysis plan.

8 Oct 2015

SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

SynAgile Corporation, a privately held pharmaceutical company that develops and commercializes drug delivery systems using its proprietary OraFuse intraoral technology platform, today announced positive results from a proof-of-concept, Phase 2a, open-label clinical trial of continuous intraoral administration of levodopa-carbidopa (LD/CD).

8 Oct 2015

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Eli Lilly and Company today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

8 Oct 2015

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan plc today announced that its infectious disease portfolio will be featured in 13 abstracts highlighting data at IDWeek 2015, which takes place from October 7-11, 2015, in San Diego.

8 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Immune-molecule-based mop-up therapy reduces specific type of breast tumor in mice

Disabling a cancer-causing pathway and administering an immune-molecule-based mop-up therapy eradicated a specific type of breast tumor in mice, according to researchers in the Perelman School of Medicine at the University of Pennsylvania.

8 Oct 2015

Medtronic unveils next-generation version of superDimension lung navigation system software

Further underscoring its ongoing commitment to lung health, Medtronic today unveiled a next-generation version of its superDimension navigation system software. The superDimension navigation system enables a minimally invasive approach to access difficult-to-reach areas of the lung, and can aid in the diagnosis of lung diseases.

8 Oct 2015

Penn study forms basis for new treatment approaches for Sezary syndrome

Sezary syndrome (SS), an aggressive leukemia of mature T cells, is more complicated at a molecular level than ever suspected, according to investigators from the Perelman School of Medicine at the University of Pennsylvania.

8 Oct 2015

New book suggests ways to reduce medical reversals

Medical reversal—when accepted medical interventions are abandoned because they are found to be ineffective—is the "most important problem in medicine today," according to the authors of a new book: Ending Medical Reversal.

8 Oct 2015

Half-matched donor bone marrow transplant just as good as full match, new study shows

Bone marrow transplantation is a life-saving therapy for many patients with blood cancers like leukemias and lymphomas. Currently, the gold standard blood-generating stem cells are obtained from a donor, a sibling, with a perfect match to the patient in order to minimize the chance of rejection and other complications. However, not all patients will have a perfectly matched sibling. Some cancer centers have begun to explore whether half-matched donors might work just as well.

8 Oct 2015

Endocrine Society issues Clinical Practice Guideline on treatment of menopausal symptoms

The Endocrine Society today issued a Clinical Practice Guideline (CPG) on identifying women who are candidates for treatment of menopausal symptoms and selecting the best treatment options for each individual.

8 Oct 2015

People in low-income countries lack access to life-saving cancer treatment

Queen's University researcher Timothy Hanna has co-authored a Lancet Oncology study that suggests as many as 90 per cent of people in low-income countries lack access to radiotherapy treatment. The lack of access to radiotherapy costs millions of lives and billions of dollars in lost economic growth in low- and middle-income countries.

8 Oct 2015

Scientists identify culprit genes behind the formation and progression of breast tumours

A team from the SingHealth Duke-NUS Academic Medical Centre, comprising scientists and clinicians from the National Cancer Centre Singapore, Singapore General Hospital and Duke-NUS Graduate Medical School, has uncovered the genetic landscape of a distinct breast tumour group called fibroepithelial tumours.

8 Oct 2015

Advanced pneumatic compression device reduces cellulitis episodes, saves money for lymphedema patients

Lymphedema patients saw a nearly 80 percent reduction in their cellulitis episodes just by using an advanced pneumatic compression device at home, according to a study in JAMA Dermatology co-authored by Vanderbilt University School of Nursing Professor Sheila Ridner, PhD, MSHSA, FAAN, and University of Minnesota School of Public Health Associate Professor Pinar Karaca-Mandic, PhD.

8 Oct 2015

Therapy News and Research

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study

Immunovia and OHSU team up to validate, commercialize blood test for early diagnosis of pancreatic cancer

NanoString Technologies will donate to honor cancer survivors featured in its newest campaign

Research on investigational menopause drug wins first prize

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

EMA completes review of proposed amendment to OncoGenex's Phase 3 AFFINITY trial protocol

SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Immune-molecule-based mop-up therapy reduces specific type of breast tumor in mice

Medtronic unveils next-generation version of superDimension lung navigation system software

Penn study forms basis for new treatment approaches for Sezary syndrome

New book suggests ways to reduce medical reversals

Half-matched donor bone marrow transplant just as good as full match, new study shows

Endocrine Society issues Clinical Practice Guideline on treatment of menopausal symptoms

People in low-income countries lack access to life-saving cancer treatment

Scientists identify culprit genes behind the formation and progression of breast tumours

Advanced pneumatic compression device reduces cellulitis episodes, saves money for lymphedema patients

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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