Search Results for "Osteocel Fda Approval"
Original Source: Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately...
Matching Channels
On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will norma...
Clinical Approvals - news, views, reports and blogs
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and eff...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in e...
Interleukin 6 IL 6 Receptor IL 6R
Although the causes of rheumatoid arthritis are not fully understood, constitutive overproduction of interleukin-6 (IL-6), a multifunctional cytokine that regulates immune response, inflammatory react...
Matching News
Aflibercept gains new approval, recommendation
Aflibercept (Eylea, Regeneron) has gained FDA approval for treatment of macular edema following CRVO and recommendation for approval by the CHMP for treatment of neovascular AMD.
Chugai files for Japanese approval of T-DM1 in breast cancer
Less than six months after the antibody-drug conjugate was filed for approval in the US and EU, Roche's affiliate Chugai has made a regulatory submission for T-DM1 (trastuzumab emtansine) in Japan....
Comment on FDA: From Risk Aversion to Approval Activism by Ben Comer
Hi Andrew, thanks for your question. I'm not certain, but I think Sherman's reference to 26 months from discovery to approval was in the context of drug candidates designated as "breakthrough therapie...
Watson gets conditional US approval to buy Actavis
Watson Pharmaceuticals gets US approval to buy Actavis but only with conditions set out by the Federal Trade Commission. Watson Pharmaceuticals has won US antitrust approval to buy Swiss firm Actavis...
SFDA To Speed Up Approval Process For Generics, New Drugs
China’s State FDA will delay processing approval applications for duplicated low-tech drugs and speed up the approval for new meds and generics depending on clinical needs, deputy commissioner Wu Zh...
Wockhardt gains approvals for ‘steady stream’ of generics
Wockhardt has won FDA approval for four generics products in a matter of days. On 16 August 2012, the India-based company announced the final approval and immediate product launch of the anti-blood cl...
Alimera racks up another Iluvien approval with German nod
Alimera Sciences has gained its fifth national approval in Europe approval for Iluvien (fluocinolone acetonide) as the Federal Ministry of Health of Germany today granted marketing authorisation for...
FDA holding post-approval device workshop
FDA will hold a public workshop on Aug. 30 to discuss post-approval studies for class III devices regulated under PMA regulations. Topics include improved strategies to implement the studies; post-app...
Matching PubMed Articles
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 fo...
Objective: To investigate the main aims of the post-approval randomized controlled trials (RCTs) on etanercept and the extent to which they were designed to gain more comparative information. Methods:...
Reporting Ethics Committee Approval in Public Administration Research.
While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of...
We compared, and determined the reasons for any differences in, the review and approval times of tyrosine kinase inhibitors (TKI) by the FDA and the EMA/CHMP. Applications for these novel cancer drugs...
Linaclotide: first global approval.
Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharma...
