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Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes.

24 Dec 2015

NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Novartis announced today that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in The New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in reducing the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine.

24 Dec 2015

Encouraging results from cannabidiol trial for treatment-resistant epilepsy

Cannabidiol (CBD), a medical marijuana derivative, was effective in reducing seizure frequency and well-tolerated and safe for most children and young adults enrolled in a year-long study led by epilepsy specialists at NYU Langone Medical Center.

24 Dec 2015

Working Group identifies many potential genetic contributors to weight loss

In the midst of the holiday season, celebratory get-togethers can mean overindulging on treats and high-calorie foods, leaving many of us struggling to keep off the extra pounds. With as many as two-thirds of American adults already carrying excess weight, and one third with obesity, maintaining weight can be the biggest challenge, say researchers.

24 Dec 2015

Penn study explores bleeding complications linked to cardiac stent placement techniques

More than 375,000 American each year experience a heart attack, during which blood flow to a part of the heart is impeded by blocked arteries. Physicians often treat patients with stents, which prop open the arteries to allow blood to flow again. They use two approaches to place stents: transradial, or entry of the catheter which delivers the stent through the wrist, or transfemoral, in which the catheter is placed through the groin.

23 Dec 2015

Women suffering from blood clots can safely take hormone replacement therapy with anticoagulants

New research published online today in Blood, the Journal of the American Society of Hematology (ASH), is the first to demonstrate that women on blood thinners can take estrogen-containing contraception or hormone replacement therapy without an increased risk of blood clots or uterine bleeding.

23 Dec 2015

TIGER-X study reviews efficacy of rociletinib therapy in patients with EGFR mutant-positive NSCLC

Oncology & Hematology Review, the peer-reviewed journal, has published a review highlighting recent data around rociletinib, an investigational therapy in patients with previously treated EGFR mutant-positive non-small cell lung cancer.

23 Dec 2015

Zurampic (lesinurad) approved to treat high levels of hyperuricemia associated with gout

The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.

22 Dec 2015

HBI-8000 granted orphan drug designation in Japan for treatment of peripheral T-cell lymphoma

HUYA Bioscience International, Founder, CEO & Executive Chair, Dr. Mireille Gillings today announced that the Ministry of Health, Labour and Welfare granted HBI-8000 orphan drug designation in Japan for peripheral T-cell lymphoma (PTCL).

22 Dec 2015

FDA approves Uptravi tablets to treat adults with pulmonary arterial hypertension

On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

22 Dec 2015

Study shows more patients with advanced NSCLC may benefit from pembrolizumab

More patients with advanced non-small-cell lung cancer (NSCLC) could benefit from pembrolizumab, says Professor Roy Herbst, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, presenting promising results from the pivotal phase 2/3 KEYNOTE-010 trial at the first ESMO Asia Congress in Singapore), in conjunction with a publication in The Lancet.

22 Dec 2015

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

22 Dec 2015

Patients with EGFR-mutated lung cancer benefit more from afatinib as first-line treatment

Patients with EGFR-activating mutations in advanced lung cancer seem to benefit more from afatinib than gefitinib as first-line treatment, researchers report at the first ESMO Asia 2015 Congress in Singapore.

21 Dec 2015

Mirati announces initiation of glesatinib Phase 2 clinical trial in NSCLC patients

Mirati Therapeutics, Inc. today announced that the Phase 2 clinical trial of glesatinib (MGCD265) has commenced. The Company also announced that "glesatinib" is the proposed generic name for MGCD265.

21 Dec 2015

TeleHealth Services, UbiCare partner to provide unique patient education and engagement solution

TeleHealth Services and UbiCare announce an exclusive business partnership that provides a unique, proven patient education and engagement solution for hospitals, healthcare systems, clinics and ambulatory centers.

21 Dec 2015

GeNeuro initiates GNbAC1 Phase IIb study in Relapsing-Remitting Multiple Sclerosis

GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced today that it has initiated its planned Phase IIb study “CHANGE-MS” (Clinical trial assessing the HERV-W Env ANtagonist GNbAC1 for Efficacy in Multiple Sclerosis) with its lead antibody GNbAC1 in Relapsing-Remitting Multiple Sclerosis (RRMS).

21 Dec 2015

Adaptimmune begins Phase I/II study of affinity enhanced T-cell therapy targeting MAGE-A10 in NSCLC patients

Adaptimmune Therapeutics plc, a leader in the use of TCR engineered T-cell therapy to treat cancer, today announced that it has initiated a Phase I/II study of its affinity enhanced T-cell therapy targeting the MAGE-A10 cancer antigen in patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC), the most prevalent type of lung cancer representing approximately 85 percent of lung cancers.

21 Dec 2015

Combination therapy can help overcome endocrine resistance in women with advanced breast cancer

Data collected in Japanese and Korean patients included in the global PALOMA3 trial provides evidence that combining palbociclib with fulvestrant is an effective strategy to overcome endocrine resistance in women with hormone receptor positive (HR+), HER2 negative (HER2-) advanced breast cancer.

20 Dec 2015

Turing Pharmaceuticals emphasizes continued availability of Daraprim

Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim.

20 Dec 2015

New vaccine shows promise against Middle East respiratory syndrome in dromedary camels

An international research project with the involvement of Universitat Autònoma de Barcelona and the Animal Health Research Centre (IRTA-CReSA), has designed a vaccine shown to be effective in protecting dromedaries against the coronavirus (CoV) that causes Middle East respiratory syndrome (MERS).

18 Dec 2015

Efficacy News and Research

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Encouraging results from cannabidiol trial for treatment-resistant epilepsy

Working Group identifies many potential genetic contributors to weight loss

Penn study explores bleeding complications linked to cardiac stent placement techniques

Women suffering from blood clots can safely take hormone replacement therapy with anticoagulants

TIGER-X study reviews efficacy of rociletinib therapy in patients with EGFR mutant-positive NSCLC

Zurampic (lesinurad) approved to treat high levels of hyperuricemia associated with gout

HBI-8000 granted orphan drug designation in Japan for treatment of peripheral T-cell lymphoma

FDA approves Uptravi tablets to treat adults with pulmonary arterial hypertension

Study shows more patients with advanced NSCLC may benefit from pembrolizumab

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Patients with EGFR-mutated lung cancer benefit more from afatinib as first-line treatment

Mirati announces initiation of glesatinib Phase 2 clinical trial in NSCLC patients

TeleHealth Services, UbiCare partner to provide unique patient education and engagement solution

GeNeuro initiates GNbAC1 Phase IIb study in Relapsing-Remitting Multiple Sclerosis

Adaptimmune begins Phase I/II study of affinity enhanced T-cell therapy targeting MAGE-A10 in NSCLC patients

Combination therapy can help overcome endocrine resistance in women with advanced breast cancer

Turing Pharmaceuticals emphasizes continued availability of Daraprim

New vaccine shows promise against Middle East respiratory syndrome in dromedary camels

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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