Natural Remedies for Ulcerative Colitis

New Drug Approvals

 

Written by Michael Sapko for drugs.com
.http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1

There are a number of medical treatments available to manage ulcerative colitis. Modern therapy is targeted at preventing flares and inducing remission (at least temporarily). These medications, however, have serious side effects, especially when taken for long periods. Corticosteroids, for example, can cause a number of cosmetic, psychological, and hormonal problems. Many patients simply cannot tolerate these medications. Children have particular problems with standard medications. When compliance with prescribed medicines is poor, treatment failure is common.1,2 Thus, many patients turn to natural remedies for their ulcerative colitis..http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1

Some herbal or organic remedies may help promote gut health and prolong the time between remissions (flares).

  • Dietary modification includes elimination of food allergens and optimizing living conditions. A relatively high proportion of Europeans (either primary or of European descent) have an allergy to gluten, a substance found…

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Alkermes unveils three new drug candidates

New Drug Approvals

Alkermes has unveiled three new drug candidates, including: a monomethyl fumarate (MMF) prodrug programme for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic.

According to Alkermes, these drug candidates demonstrate the company’s focus on unmet medical needs in specific patient populations and show the productivity of its expanded R&D capabilities.

read all at

http://www.manufacturingchemist.com/news/article_

page/Alkermes_unveils_three_new_drug_candidates/90167

 

 

 

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Genentech announced positive results from the Phase 3 CLL11 study, Leukemia Trial

New Drug Approvals

Afutuzumab

Obinutuzumab (GA101)

RO5072759

Genentech announced positive results from the Phase 3 CLL11 study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan (rituximab) plus chlorambucil.

The CLL11 study is being conducted in cooperation with the German CLL Study Group (GCLLSG). These final data were reached well ahead of the target completion date in 2014 as a result of the magnitude of difference seen between the two study arms.

.http://www.dddmag.com/news/2013/07/strong-results-phase-3-leukemia-trial?et_cid=3386057&et_rid=523035093&type=cta

Afutuzumab is a monoclonal antibody being developed by Hoffmann-La Roche Inc. for the treatment of lymphoma.[1] It acts as an immunomodulator.[2][3] It was renamed obinutuzumab in 2009.[4]

Class/mechanism: Glyco-engineered anti-CD20 IgG1 type II monoclonal antibody. Engineered with a modified elbow hinge residue (valine instead…

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First biosimilar filgrastims launched in Japan

New Drug Approvals

International nonproprietary name: Filgrastim

 Chemical name: N-L- Methionyl colony-stimulating factor (human genetically engineered); non-glycated protein consisted of 175 amino acids.

Chemical name: N-L- Methionyl colony-stimulating factor (human genetically engineered); non-glycated protein consisted of 175 amino acids.

Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes.[1] It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is different from G-CSF naturally made in humans.

Hematopoietic growth factor. Interacting with receptors on the surface of hematopoietic cells it regulates production and release of neutrophils from the bone marrow to the peripheral blood. Dose dependant number growth of neutrophils with normal or increased functional activity is passing for 24 hours.

Filgrastim is marketed under several brand names, including Neupogen (

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Biosimilars applications under review by EMA – 2013 Q2

New Drug Approvals

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.

read all at

http://www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q2

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