Search

The article reports increase in the number of drug and biologics license applications (BLAs) approved by the U.S. Food and Drug Administration in 2014. It mentions pharmaceutical companies that got BLA including Amgen, Merck and Bristol-Myers Squibb. Topics discussed include speedily drug approval ahead of prescription drug user fee act (PDUFA) dates, FDA's approval to AbbVie's Viekira Pak drug for hepatitis C, and FDA approval for rare disease drug.

The article offers an update regarding biopharmaceutical approval in the U.S. and European Union (EU). A lists of all recombinant biologics approved from January 2010 until July 2014 is presented. The types of biopharmaceutical drugs that have reached the U.S. and EU market and also the indications for which they are registered have been examined.

The article focuses on how to develop a successful translational research centers. Topics include the submission of drug application-enabling studies to the U.S. Food and Drug Administration (FDA), the benefits of commercializing translational research, and the survey which provides recommendations to have a powerful research centers such as the need to have multiple funding sources and the use of third parties.

The article offers the author's insights regarding a survey on breakthrough therapy designation (BTD) approved by U.S. Food and Drug Administration (FDA) as of March 2014. Topics include the possible effects of BTD for prices and reimbursements of drugs, creation of BTD in compliance with FDA Safety and Innovation Act of 2012, and the availability of BTD for drugs intended for serious medical condition.

The article offers information on the reduced number of drugs approvals manufactured by pharmaceutical companies from the U.S. Food and Drug Administration (FDA) in 2013 and also informs that a large number of new innovative drugs are discovered. Topics discussed include approval of breakthrough designation (BTD) drugs by Pharmacyclics, information about the drug tyrosine kinase inhibitor Gilotrif (afatinib) by Boehringer Ingelheim, and use of biological markers as drug candidates.

The article focuses on the contributions of the U.S. National Institutes of Health (NIH) Intramural Research Program (IRP) and inventions from public-sector research institutions (PSRIs) to the development of drugs and biologics approved by the U.S. Food and Drug Administration (FDA). It presents an analysis of products developed from inventions from the PSRI, their public health impact, and characterization of drug products.

The interaction between the HSP90 chaperone and its client kinases is sensitive to the conformational status of the kinase, and stabilization of the kinase fold by small molecules strongly decreases chaperone interaction. Here we exploit this observation and assay small-molecule binding to kinases in living cells, using chaperones as 'thermodynamic sensors'. The method allows determination of target specificities of both ATP-competitive and allosteric inhibitors in the kinases' native cellular context in high throughput. We profile target specificities of 30 diverse kinase inhibitors against >300 kinases. Demonstrating the value of the assay, we identify ETV6-NTRK3 as a target of the FDA-approved drug crizotinib (Xalkori). Crizotinib inhibits proliferation of ETV6-NTRK3-dependent tumor cells with nanomolar potency and induces the regression of established tumor xenografts in mice. Finally, we show that our approach is applicable to other chaperone and target classes by assaying HSP70/steroid hormone receptor and CDC37/kinase interactions, suggesting that chaperone interactions will have broad application in detecting drug-target interactions in vivo. [ABSTRACT FROM AUTHOR]

In 2010, the US Food and Drug Administration (FDA) approved a generic low-molecular-weight heparin without clinical safety or efficacy data under the Abbreviated New Drug Application (ANDA) pathway. To enable a determination of active ingredient sameness of generic and innovator enoxaparin products, the FDA developed a scientifically rigorous approach based on five criteria: first, equivalence of physicochemical properties; second, equivalence of heparin source material and mode of depolymerization; third, equivalence in disaccharide building blocks, fragment mapping and sequence of oligosaccharide species; fourth, equivalence in biological and biochemical assays; and finally, equivalence of in vivo pharmacodynamic profile. In addition to fulfillment of these criteria, FDA also used in vitro, ex vivo and model animal data to ensure there was no increased immunogenicity risk of the generic enoxaparin product relative to the brand name product. The approval of the highly complex enoxaparin product using this framework under the ANDA pathway represents a major development. It also suggests that analytical and scientific advancements may in certain cases allow the elimination of unnecessary in vivo testing in animals and humans. [ABSTRACT FROM AUTHOR]

The article offers information on the approval of several new drugs by the U.S. Food and Drug Administration (FDA). It states that the therapies granted orphan drug status because they address rare diseases which make up to 32 percent of the new drug approvals. Table listing several drugs including Ducord, Gintuit and Raxibacumab is also presented.

The author argues on the legislation that has been passed in Europe allowing the approval of the competing versions of biopharmaceuticals based on an abbreviated approval procedure. It informs that the products are evaluated on the basis of these pathways called biosimilars and are approved on the basis of the quality and comparative preclinical studies.

Drug approvals were up in 2011, reversing the trend of the last decade. Jim Kling reports. [ABSTRACT FROM AUTHOR]

For the first time in more than 50 years, the US Food and Drug Administration has approved a drug specifically for the treatment of systemic lupus erythematosus (SLE). This drug, belimumab (Benlysta), is a human monoclonal antibody that neutralizes the B-cell survival factor, B-lymphocyte stimulator (BLyS). The approval of belimumab combined a pioneering approach to genomics-based gene discovery, an astute appreciation of translational medicine, a disciplined clinical strategy, a willingness to take calculated risks, a devoted cadre of patients and physicians and a healthy dose of serendipity. Collectively, these efforts have provided a model for the development of a new generation of drugs to treat the broad manifestations of SLE. However, as a substantial percentage of SLE patients do not respond to belimumab, further research is needed to better characterize the pathogenetic mechanisms of SLE, identify additional therapeutic targets, and develop effective and nontoxic novel agents against these targets. [ABSTRACT FROM AUTHOR]

The article reports on the approval of the drug Benlysta as an effective relief for systematic lupus erythematosus. The drug missed the threshold during phase 2 trial and demonstrated only moderate efficacy in phase 3. Benlysta was developed through the collaboration between Human Genome Sciences and GlaxoSmithKline. It is a humanized monoclonal antibody against the B-lymphocyte stimulator, BLyS, a protein that promotes proliferation and maturation of antibody-producing B cells.

The article reports that the U.S. Food and Drug Administration (FDA) has approved the hepatitis C virus protease inhibitors Incivek from Vertex Pharmaceuticals and Victrelis from Merck. The drugs' cure rate is doubled when combined with polyethylene glycol-decorated interferon (INF)-alpha and ribavrin. It reports that following the FDA's approval of the two drugs, a number of companies have moved to developing all-oral combination antivirals without INF-alpha.

The article discusses developments in the biopharmaceutical approval landscape in the U.S. and European Union (EU) as of June 2010. Thirty out of 58 biopharmaceuticals approved from January 2006 to June 2010 are hormones, growth factors and other regulatory molecules. In 2009, seven monoclonal antibody (mAb) products have emerged in the market, four of which are fully human products. Also noted is the lack of gene product approval for marketing licenses in Europe or the U.S.

This article reports that Novo Nordisk awaits a decision from the U.S. Food & Drug Administration (FDA) on its anti-diabetic drug Victoza in 2009. An FDA Endocrinologic and Metabolic Drugs Advisory Committee conducted a discussion which suggests that C-cell thyroid cancer could be a potential safety concern associated with the drug. The Danish company seeks the approval to secure a share in the type 2 diabetes market. The company conducted a number of studies to examine the efficacy and safety of the drug.

The article discusses the development of botanical prescription drugs that meet the standards set forth by the U.S. Food and Drug Administration (FDA) for clinical testing and quality control. In October 2006 the FDA approved the new drug application (NDA) for sinecatechins, a topical treatment for perianal and genital condyloma derived from green tea leaves. This approval proves that natural therapies can be developed to meet the guidelines set forth for botanical drug products in 2004. Due to botanical products being derived from raw materials that are minimally purified, contamination with pesticides, trace heavy metals and infectious microorganisms is of concern. Steps to ensuring approval are given.

Presents news briefs related to food and pharmaceutical industry as of August 2003. Mechanism of action of the drug Xolair approved by the U.S. Food and Drug Administration for the treatment of allergic asthma; Terms and conditions of the deal of the U.S. firm Cell Therapeutics Inc. to buy NovusPharma SpA; Attitude of the public towards genetically modified food in Great Britain.

The article reports on the approval of another bispecific antibody, Removab (catumaxomab), for treating malignant ascites, a build-up of cancerous fluid in the peritoneal cavity, by the European Medicines Agency. The drug from Munich, Germany-based Trion Pharma GmbH was based on old technology. Its high levels of immunogenicity has limited its use.