Incoming News
West Midlands Centre for Adverse Drug Reactions (UK): Court Backs Injunction Blocking Generic Versions of Lilly's Evista
A federal appeals court affirmed an injunction blocking generic versions of Lilly's osteoporosis drug Evista. (Source: WSJ.com: Health)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Botox Maker Settles Case
Allergan agreed to pay $600 million to settle criminal and civil allegations that it had marketed Botox for medical uses, like pain and headache, not approved by the Food and Drug Administration. (Source: NYT Health)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Predictors of Placebo Responses in Bipolar Treatment Trials Identified
Symptomatic improvement over baseline was similar in the placebo groups in a meta-analysis of placebo-controlled trials, regardless of whether or not the active drug proved effective. Medscape Medical News (Source: Medscape Today Headlines)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): U.S. to aggressively pursue drug misbranding cases
WASHINGTON (Reuters) - The U.S. Department of Justice will continue to "aggressively pursue" pharmaceutical companies that illegally market drugs for uses that have not been approved by health regulators, a top agency official said on Wednesday. (Source: Reuters: Health)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Pfizer Agrees to Acquire FoldRx
Pfizer agreed to buy privately held FoldRx Pharmaceuticals, whose leading drug candidate is a therapy for a genetic neurodegenerative disease for which the only current therapy is a liver transplant. (Source: WSJ.com: Health)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Pfizer Agrees to Acquire Drug Developer FoldRx
Pfizer agreed to buy privately held FoldRx Pharmaceuticals, whose leading drug candidate is a therapy for a genetic neurodegenerative disease for which the only current therapy is a liver transplant. (Source: WSJ.com: Health)
MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Eisai Announces Extension Of FDA Review Of Drug Application For Investigational Agent Eribulin Mesylate
Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Nanotherapeutics Submits Investigational New Drug Application To FDA For Clinical Testing Of Oral Drug To Treat Radiation Exposure
Nanotherapeutics, Inc., announced that it has filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) for NanoDTPA⢠an orally administered capsule that is a less invasive treatment alternative to the FDA approved injectable Zn-DTPA (diethylenetriamine pentacetic acid). DTPA is used to remove radioactive compounds from the body to help eliminate the contamination. The NanoDTPA⢠capsule is a unique orally-bioavailable fine particle formulation that allows DTPA to be absorbed into the body from the gastrointestinal tract... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Death Of Injecting Drug User In Leicestershire
The Health Protection Agency (HPA) and NHS Leicestershire County and Rutland can confirm that they are investigating the death of a drug injecting heroin user in Leicestershire. Testing of samples from the patient has confirmed the presence of anthrax. This is the fourth case of anthrax seen in an injecting drug user in England, the first being announced in London on 5 February 2010. Similar cases have been seen in Scotland since December 2009 with forty seven cases having been confirmed and one in Germany... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Lytix Biopharma AS Announces Approval By Hungarian Authorities To Start Phase IIa Clinical Trial With LytixarTM In Gram Positive Skin Infections
The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with LytixarTM (LTX-109) treatment of skin infections caused by Gram positive bacteria. According to Lytix Biopharma CEO Gunnar Sælid, "We are delighted to announce the approvals by the Hungarian Regulatory Authorities and appropriate Ethics Committee to test our novel antimicrobial drug LytixarTM (LTX-109) in patients whom have skin infections caused by Gram positive bacteria... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): FDA Alleges Farm Sold Cattle As Human Food With Illegal Drug Residues
The Department of Justice, USA, has filed a complaint for permanent injunction on behalf of the FDA (Food and Drug Administration) against Scenic View Dairy of Hamilton, Michigan, the company's president as well as three managers - they are alleged to have sold dairy cows containing illegal drug residues - antibiotics - in edible tissues for human consumption... (Source: Health News from Medical News Today)
MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Individualized chemotherapy in lung cancer
Chemotherapy is the best broad defense against cancer recurrence after surgical resection. However, it is difficult to predict which patients will benefit from which regimen of anticancer drugs, if at all. Building on existing knowledge, a study reported in the September edition of the Journal of Thoracic Oncology (JTO), analyzed the usefulness of adjuvant chemotherapy for non-small cell lung cancer (NSCLC) based on the histoculture drug response assay (HDRA). After seven years of study, scientists concluded that the use of adjuvant (post-operative) chemotherapy based on results of the in vitro HDRA improved the survival and prognosis of patients with NSCLC who had undergone surgery and whose results of the HDRA assay showed chemosensitivity to the specific drugs used for therapy........ (...
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Discovery Of New Protein That Gets To The Roots Of Obesity And Osteoporosis
Here's good news for anyone trying to lose weight or has osteoporosis: Scientists from Maine are on the trail of a weight loss drug that may revolutionize how we treat these two conditions. In a new research report published in the September 2010 print issue of The FASEB Journal, the researchers describe a newly discovered protein, called "Sprouty," responsible for regulating body fat and bone mass. Then they manipulated how much of this protein was expressed in different groups of mice specially bred to have some human genes... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Vitrolife: New Study Shows Improved Survival With Perfadex
A recently published study in The Journal of Heart and Lung Transplantation shows that the patients who are most seriously ill before lung tranplantation have better one-year survival when Perfadex is used as the preservation solution for donor lungs compared with UW solution. Furthermore, the patients who received lungs preserved in Perfadex ran a significantly lower risk of being affected by rejection reactions requiring treatment... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Drug costs would push millions more into poverty: study
LONDON (Reuters) - Tens of millions of people in low and middle income countries would be pushed below the poverty line by buying common but vital medicines which are already unaffordable to hundreds of millions more, a study has found. (Source: Reuters: Health)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): U.N. Secretary-General, UNAIDS Executive Director Highlight Role NGOs Can Play In Achieving MDGs
During the 63rd U.N. Department of Public Information/NGO Conference on Monday in Melbourne, Australia, U.N. Secretary-General Ban Ki-moon "call[ed] on delegates to do more to save the lives of mothers and babies," the Australian Associated Press/Sydney Morning Herald reports (Alexander/Rose, 8/30). Addressing the conference attendees via video, Ban noted that "partnerships between civil society and governments and the private sector will be critical if the world is to make serious inroads in the number of preventable deaths, particularly of women and children," U.N. News Centre writes... (Source: Health News from Medical News Today)
MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): FDA Seeks Court Order Against Michigan Dairy
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues. The complaint, filed Aug. 31, 2010, in the U.S... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): New Social Intervention To Help Pakistani Women With Depression
Researchers from the University of Manchester have developed a social intervention to help British Pakistani women with depression. Their 10-week programme, which was trialled in the north-west of England, helped the women feel more positive and improved their satisfaction and social functioning. The findings are published in the September issue of the British Journal of Psychiatry. Previous studies have shown that South Asian women living in the UK - particularly those of Pakistani origin - have a higher rate of depression, suicide and self-harm than White women... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): FDA Launches New Organizational Performance Management System
The U.S. Food and Drug Administration launched an innovative performance management system designed to advance the President's commitment to transparency, public participation, and collaboration in the work of government. The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership. Importantly, the public will be able to track this data and the agency's progress through the FDA-TRACK website... (Source: Health News from Medical News Today)
Categories: Adverse Reactions
West Midlands Centre for Adverse Drug Reactions (UK): Consequences of Comorbid Sleep Apnea in the Metabolic Syndrome—Implications for Cardiovascular Risk
Conclusion: Patients with MetSyn and comorbid OSA have higher BP, higher sympathetic drive, and diminished BRS, compared with patients with MetSyn without OSA. These adverse cardiovascular and autonomic consequences of OSA may be associated with poorer outcomes in these patients. Moreover, increased BP and sympathetic drive in patients with MetSyn+OSA may be linked, in part, to impairment of baroreflex gain.
Keywords: Cardiovascular risk, sleep apnea, metabolic syndrome, sympathetic activation, baroreflex control (Source: Sleep)
Categories: Adverse Reactions