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Oncolytics Biotech Inc., a biotechnology company concentrated on the development of oncolytic viruses as potential cancer therapeutics. Company has presented an application to the US Food and Drug Administration (FDA) for REOLYSIN to get Orphan Drug Designation for the treatment of gastric cancer.
Health ministry to amend Form 12-B of D&C Rules; Form 12-B of the Drugs and Cosmetics Rules is for giving permission for import of small quantities of drugs for personal use. The Union health ministry will soon amend Rules in this regard.
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The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug “Feraheme”. It could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product. Health care professionals should strictly follow the recommendations mentioned in the drug label. Patients should immediately call doctor if there is breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.
Biocon Ltd, Asia's premier biopharmaceuticals company, announced that its Insulin Glargine has been approved by COFEPRIS, the Mexican health authority, through its partner PiSA Farmaceutica (PiSA).
Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics, has received the final approval from the United States Food and Drug Administration (USFDA) for sale of drugs meant to prevent post-menopause osteoporosis.USFDA granted Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg.
The cumbersome days of stressful, manual, wired monitoring of the unborn child in pregnant mothers will soon end - thanks to a new system unveiled at a hospital here. The Lokmanya Tilak Municipal General Hospital, known as the Sion Hospital, has introduced system in order to monitor the fetal heart rate and condition of the baby in the uterus of a pregnant lady for the first time in India.
Results from the phase 1 clinical trial of an Ebola vaccine based on the current strain of the virus suggests it is safe to use and provokes an immune response in recipients, Chinese scientists say. Until now, all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976.
In a world first, researchers have found that a naturally occurring chemical attracts pregnant malaria transmitting mosquitoes - a discovery which could boost malaria control efforts. The chemical, cedrol, found in mosquito breeding sites near Africa's Lake Victoria, could be used in traps that would 'attract and kill' the female mosquito, preventing reproduction before she lays hundreds of eggs.
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