Botulinum toxin for injection is a purified and diluted protein which isolated from the bacterium Clostridium botulinum . It one of most potent toxins known to humankind. C. an anaerobic Gram-positive, spore-forming present naturally in soil, plants, static water bodies, gastrointestinal tract mammals aquatic life. Different formulations are available. FDA approval these varies. This article re...

BACKGROUND AND PURPOSE The Asymptomatic Carotid Atherosclerosis Study is a prospective, multicenter, randomized clinical trial of carotid endarterectomy for the treatment of asymptomatic hemodynamically significant stenosis. This report describes the selection process for participating surgeons in the trial. METHODS The Surgical Management Committee established guidelines for minimal annual e...

Eric Winer, MD, professor of medicine at Harvard Medical School and director of the Breast Oncology Center at Dana-Farber Cancer Institute, discusses presurgical trials for breast cancer and the roles such trials may eventually play in drug approvals.

Since the approval of rituximab in 1997, monoclonal antibodies (mAbs) have become an increasingly important component of therapeutic regimens in oncology. The success of mAbs as a therapeutic class is a result of great strides that have been made in molecular biology and in biotechnology over the past several decades. Currently, there are 14 approved mAb products for oncology indications, and t...

Gene therapy is a new therapeutic approach which is tested in numerous diseases connected with either non or only limited therapeutic effects. This paper aims at discussing the actual state of the clinical development of gene-therapy which targets an approval by either the FDA or EMEA. Basis of all the figures and tables presented is a BioMedNet/Medline search reviewing all titles found under t...

Angiogenesis is a fundamental mechanism of cancer growth and invasion. Current translational approaches are using both small-molecule inhibitors and antibodies that modulate various steps of these processes, and several such compounds have already received regulatory approval for the therapy of specific indications in cancer. Among the many molecular targets involved in the control of angiogene...

BY TERRY G. MAHN O ne of the more controversial provisions in the legislative behemoth known as the 21 Century Cures Act, signed into law by President Obama on December 13, 2016, involves an overhaul of the regulatory approval process for new uses for old drugs, a fertile target for private investment in the important field of precision medicine. To incentivize investment in drugs that have alr...

OBJECTIVE To evaluate patterns of antipsychotic use. DESIGN, SETTING, AND MEASUREMENTS: We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Dru...

Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Reg...

Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope® (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin®). ...