Search Results for “research” – Page 285

Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.

Source: chi-med
669
December 18, 2017

Magnetically Guided Bacteria Move Confidently Within Strong Currents, May Soon Deliver Drugs Inside Body

Researchers at Queen’s University in Canada have managed to get a special type of bacteria to swim against a strong current, opening up the possibility of using the organisms as drug delivery vehicles. The team is using magnetotactic bacteria which have magnetic crystals within them and naturally orient themselves with the Earth’s magnetic field. By setting up the external magnetic field, the researchers were able to coax the bacteria to move in predictable ways and directions.

Source: medgadget
426
December 15, 2017

bacteria magnetotactic Researches

New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, today announced that the European Commission (EC) granted Marketing Authorization for lyophilized ONCASPAR (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients.1 The approval – which authorizes Shire to market lyophilized ONCASPAR in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12.

Source: Shire
608
December 15, 2017

ALL Antineoplastic New Approvals

Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease

The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study

Source: press.bayer
611
December 15, 2017

Bayer CAD/PAD Company Insight Janssen rivaroxaban

Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease

Ionis Pharmaceuticals, Inc. (IONS) announced today that Roche has exercised its option to license IONIS-HTTRx following the completion of a Phase 1/2a randomized, placebo-controlled, dose escalation study of IONIS-HTTRx in people with Huntington's disease (HD). Roche will now be responsible for all development and commercial activities. IONIS-HTTRx is the first therapy in clinical development designed to target the underlying cause of HD by reducing the production of the toxic mutant huntingtin protein (mHTT). In conjunction with the decision to license IONIS-HTTRx, Ionis earned a $45 million license fee from Roche.

Source: finance.yahoo
485
December 15, 2017

Clinical Trials Huntington’s Disease IONIS-HTTRx

11 Brilliant Ways Therapists Control Their Holiday Stress

Sometimes even the experts need a little help staying holly and jolly. Research shows holiday season stress can feel insurmountable. No one is immune. Mental health professionals, who are usually helping others manage emotions, put their own advice into practice as the year winds down.

Source: msn
378
December 15, 2017

holiday season stress Researches

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

The U.S. Food and Drug Administration(FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA.

Source: Prnewswire;
489
December 14, 2017

EGPA New Approvals vasculitis

FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.

Source: massdevice
568
December 14, 2017

FDA interoperable medical device Policy

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)

Source: investor.bayer
701
December 14, 2017

Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®

‘Ground-breaking’ new drug gives hope in Huntington’s disease

A DNA double helix is seen in an undated artist's illustration released by the National Human Genome Research Institute to Reuters on May 15, 2012. REUTERS/National Human Genome Research Institute/Handout.

Source: in.reuters
575
December 13, 2017

devastating genetic disease Huntington’s Disease Researches

Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Magnetically Guided Bacteria Move Confidently Within Strong Currents, May Soon Deliver Drugs Inside Body

New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease

Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease

11 Brilliant Ways Therapists Control Their Holiday Stress

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

FDA suggests controls on interoperable devices

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

‘Ground-breaking’ new drug gives hope in Huntington’s disease

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