Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that the US Food and Drug Administration (FDA) has classified the Bydureon (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
The Zilver PTX (Cook Medical, Bloomington, IN) polymer-free paclitaxel-eluting peripheral stent shows near-perfect two-year durability and safety in a nonrandomized study presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2010 Scientific Sessions in San Diego .
The multinational drug company GlaxoSmithKline (GSK), which had run an advertisement blitzkrieg in several national newspapers in the country on cervical cancer vaccine late last year in gross violation of Drugs and Cosmetics Act, 1940 and Drugs and Magical Remedies Act 1954, has been completely absolved of any irregularities by the drug controller general of India (DCGI) Dr Surinder Singh, it is learnt.
In a randomized, multicenter study of advanced Parkinson's disease (PD) patients, those treated with deep brain stimulation (DBS) of the subthalamic nucleus combined with best medical therapy had better self-reported quality of life at 1 year than those treated with best medical therapy alone.
April 29, 2010 (Boston, Massachusetts) — Long-term users of anabolic androgenic steroids have a high risk of developing cardiac dysfunction, which may be severe enough to increase the risk of heart failure, a new study suggests .
The study, published online April 27, 2010 in Circulation: Heart Failure, was conducted by a group led by Dr Aaron Baggish (Massachusetts General Hospital, Boston, MA).
The Pharmacy Council of India (PCI), the statutory body governing the pharmacy education in the country, has warned against the move by some of the institutes to start a second shift for pharmacy courses. PCI said that it would not approve such courses or students taking such courses as per the Pharmacy Act, 1948.
The resistance of cytomegalovirus (CMV) to ganciclovir prophylaxis might be related to subtherapeutic levels of the antiviral agent, according to investigators from Loyola University Medical Center in Maywood, Illinois.
Although the study was small, the findings sparked a lively discussion among those attending the session on transplant infections at the International Society for Heart & Lung Transplantation 30th Anniversary Meeting.
As part of a well-established organized screening program, primary human papillomavirus (HPV) screening with cytology triage is more sensitive than conventional cytology in the detection of cervical intraepithelial neoplasia (CIN) grade III, according to the results of a randomized trial reported online April 28 in the BMJ.
Maharashtra Food and Drug Administration (FDA) has found 44 drugs not-of-standard-quality during its inspection in March 2010. Most of the not-of-standard-quality drugs were from tax-holiday states Himachal Pradesh and Uttaranchal. And every month, the number of sub-standard drug samples keeps increasing and firms from these two states have major share in this list.