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A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant. The average time from investigational new drug (IND) filing to market was 6.7 years for 11 mABs approved between 1994 and 2003 but shot up to 8.3 years for 12 mAbs approved between 2004 and March 9, 2011, according to Deloitte Recap LLC’s analysis, Therapeutic Monoclonal Antibodies – Insights, Strategies and Data.
Cholesterol is a fat-like, waxy substance that can be found in all parts of your body. It helps your body make cell membranes, many hormones, and vitamin D. The cholesterol in your blood comes from two sources: the foods you eat and your liver. But your liver makes all the cholesterol your body needs.
A pneumothorax is usually caused by an injury to the chest, such as a broken rib or puncture wound. It may also occur suddenly without an injury. A pneumothorax can result from damage to the lungs caused by conditions such as chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, and pneumonia.
Trisomy 18, also called Edwards syndrome, is a chromosomal condition associated with abnormalities in many parts of the body. Individuals with trisomy 18 often have slow growth before birth (intrauterine growth retardation) and a low birth weight. Affected individuals may have heart defects and abnormalities of other organs that develop before birth. Other features of trisomy 18 include a small, abnormally shaped head; a small jaw and mouth; and clenched fists with overlapping fingers. Due to the presence of several life-threatening medical problems, many individuals with trisomy 18 die before birth or within their first month. Five to 10 percent of children with this condition live past their first year, and these children often have severe intellectual disability.
Waardenburg syndrome is a group of genetic conditions that can cause hearing loss and changes in coloring (pigmentation) of the hair, skin, and eyes. Although most people with Waardenburg syndrome have normal hearing, moderate to profound hearing loss can occur in one or both ears. The hearing loss is present from birth (congenital). People with this condition often have very pale blue eyes or different colored eyes, such as one blue eye and one brown eye. Sometimes one eye has segments of two different colors. Distinctive hair coloring (such as a patch of white hair or hair that prematurely turns gray) is another common sign of the condition. The features of Waardenburg syndrome vary among affected individuals, even among people in the same family.
The timing of the nausea or vomiting can indicate the cause. When appearing shortly after a meal, nausea or vomiting may be caused by food poisoning, gastritis (inflammation of the stomach lining), an ulcer, or bulimia. Nausea or vomiting one to eight hours after a meal may also indicate food poisoning.
The menstrual cycle is the regular natural change that occurs in the female reproductive system like the uterus and ovaries that make pregnancy possible. The cycle is required for the production of ovocytes, and for the preparation of the uterus for pregnancy.
Graft-versus-host disease (GVHD) is a common complication after an allogeneic transplant, a transplant in which cells from a family member, unrelated donor or cord blood unit are used. In GVHD, the immune cells from the donated marrow or cord blood (the graft) attack the body of the transplant patient (the host).
Glycogen storage disease (GSD, also glycogenosis and dextrinosis) is the result of defects in the processing of glycogen synthesis or breakdown within muscles, liver, and other cell types. GSD has two classes of cause: genetic and acquired.
The pituitary gland is often portrayed as the "master gland" of the body. Such praise is justified in the sense that the anterior and posterior pituitary secrete a battery of hormones that collectively influence all cells and affect virtually all physiologic processes. The pituitary gland may be king, but the power behind the throne is clearly the hypothalamus. As alluded to in the last section, some of the neurons within the hypothalamus - neurosecretory neurons - secrete hormones that strictly control secretion of hormones from the anterior pituitary. The hypothalamic hormones are referred to as releasing hormones and inhibiting hormones, reflecting their influence on anterior pituitary hormones.
-MEN1 syndrome is composed of hyperparathyroidism, gastrinoma (pancreatic tumor) and pituitary tum or(remember the 3 Ps). Hyperparathyroidism in MEN1 is caused by hyperplasia of the parathyroid glands. Removal of 3 1/2 glands or total parathyroidectomy with autotransplantation is necessary.
Warfarin is an anticoagulant medication - it is used to slow down the blood-clotting process. Anticoagulants are used to prevent blood clots which may cause vein blockages, heart attack and stroke. Warfarin is known under the brand names Warfant, Jantoven, Coumadin, Lawarin, Marevan, and Waran.
patient has fever, hypotension, swelling, and erythema of his left leg. Notably, his leg is more painful to palpation than might be expected after visual inspection. These symptoms are very concerning for necrotizing fasciitis. Necrotizing fasciitis is a fulminant infection of the subcutaneous tissue that spreads rapidly along the fascial planes and leads to extensive tissue necrosis and shock. Treatment • Requires surgical debridement & broad-spectrum antibiotics
Chorionic villus sampling, often referred to as CVS, is a diagnostic test for identifying chromosome abnormalities and other inherited disorders. This test may be recommended by your health care provider, if you or your partner has family medical histories that reveal potential risks.
This syndrome was previously known as reflex sympathetic dystrophy, algodystrophy, causalgia, Sudeck atrophy, transient osteoporosis, and acute atrophy of bone. Usually occurring after an injury, CRPS presents with pain out of proportion to the injury, temperature change, edema, and abnormal skin color. Type I CRPS (90% of CRPS cases) occurs without a definable nerve lesion, while type II occurs with a definable nerve lesion. The pathogenesis is likely due to an injury causing increased sensitivity to sympathetic nerves, an abnormal response to and sensation of pain, and increased neuropeptide release causing burning pain to light touch (allodynia).