FDA approves Gazyva for chronic lymphocytic leukemia

New Drug Approvals

Drug is first with breakthrough therapy designation to receive FDA approval

The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).

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http://www.pharmalive.com/fda-approves-roche-s-gazyva

 

my old article cut paste

Roche’s new leukaemia drug, Obinutuzumab, superior to Rituxan in clinical trial

JULY 25, 2013 12:52 AM / 6 COMMENTS / EDIT

 Reblogged from :

Click to visit the original postJuly 24 2013 | By Márcio Barra

Roche has announced that its experimental leukemia drug GA101, or obinutuzumab, used in combination with chemotherapy, was better than Rituxan at helping people with chronic lymphocytic leukemia live longer without their disease worsening, according to the results from the second phase of the clinical trial. Both drugs were tested and compared in combination with chlorambucil.

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EGA’S VISION OF FUTURE OF GENERIC AND BIOSIMILAR INDUSTRIES IN EUROPE

VITAMINS, COMMON INFORMATION

New Drug Approvals

A vitamin (US /ˈvtəmɪn/ or UK /ˈvɪtəmɪn/) is an organic compound required by an organism as a vital nutrient in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals, and biotin (vitamin H) and vitamin D are required in the human diet only in certain circumstances.

 

 

 

 

Thiamin

What it does:

  • helps convert…

View original post 1,230 more words

VITAMINS, COMMON INFORMATION

New Drug Approvals

A vitamin (US /ˈvtəmɪn/ or UK /ˈvɪtəmɪn/) is an organic compound required by an organism as a vital nutrient in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals, and biotin (vitamin H) and vitamin D are required in the human diet only in certain circumstances.

 

 

 

 

Thiamin

What it does:

  • helps convert…

View original post 1,230 more words

VITAMINS, COMMON INFORMATION

New Drug Approvals

A vitamin (US /ˈvtəmɪn/ or UK /ˈvɪtəmɪn/) is an organic compound required by an organism as a vital nutrient in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals, and biotin (vitamin H) and vitamin D are required in the human diet only in certain circumstances.

 

 

 

 

Thiamin

What it does:

  • helps convert…

View original post 1,230 more words

Bayer’s Stivarga® (regorafenib) Tablets Approved in Europe

New Drug Approvals

WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 30, 2013 /PRNewswire/ — Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC).

In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

READ ALL AT http://www.pharmalive.com/ec-approves-bayer-s-stivarga

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File:Regorafenib.svg

Regorafenib

cas 755037-03-7

4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide hydrate

February 25, 2013 — The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

GIST is a tumor in which cancerous cells form in the tissues of…

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Otsuka Receives Complete Response Letter From U.S. Food And Drug Administration For Tolvaptan For Use In Patients With Autosomal Dominant Polycystic Kidney Disease

New Drug Approvals

Tokyo, Japan – August 30, 2013 – Otsuka Pharmaceutical Co., Ltd announced today the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for tolvaptan for the treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The FDA issues CRLs to convey that their initial review of an application is complete; however, they cannot approve the application in its present form and request additional information.
In its letter to Otsuka, the FDA requested Otsuka provide additional data to further evaluate the efficacy and safety of tolvaptan in patients with ADPKD.
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