Adverse Drug Reaction News and Research

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Genetics and cardiovascular drugs: an interview with Nancy Lurker, CEO of PDI and Paul Kinnon, CEO of Transgenomic, Inc.

People inherit different versions of any particular gene, and some genes affect how patients process and metabolize medicines. This especially holds true for people with cardiovascular (CV) disease. They may be fast, slow or non-metabolizers and might also react badly (with serious adverse events) to certain drug therapies or not at all.

27 Nov 2013

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the presentation of interim data from a Phase 1B trial (PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy, in patients with previously-treated non-small cell lung cancer (NSCLC). The data were presented today by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, at the 15th World Conference on Lung Cancer in Sydney, Australia (Abstract #2416).

31 Oct 2013

Boehringer Ingelheim’s interim data from Phase II HCV clinical collaboration with Presidio Pharmaceuticals accepted for presentation at AASLD

Boehringer Ingelheim today announced that interim data from its Phase II hepatitis C (HCV) clinical collaboration with Presidio Pharmaceuticals have been accepted for presentation as a late breaker poster at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place 1-5 November in Washington, D.C. (1) The poster presentation will be on Monday 4 November.

8 Oct 2013

Smokers with a history of major depressive disorder (MDD) taking varenicline have significantly higher likelihood of quitting smoking than placebo

Results of a Pfizer-commissioned study published this month in Annals of Internal Medicine reveal that smokers with a past or present diagnosis of major depressive disorder (MDD)* taking varenicline had a significantly higher likelihood of quitting smoking (after 12 weeks and at 52 weeks) than those who were given a placebo.

18 Sep 2013

Improved lung function in patients with moderate asthma severity observed with investigational Tiotropium

Boehringer Ingelheim will present a pooled analysis of new data from the Phase 3 UniTinA-asthma® program at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona. The data from the individual MezzoTinA-asthma® Phase 3 studies (NCT01340209 and NCT00565266), from which the pooled data are derived, show the addition of tiotropium delivered via the Respimat® inhaler to medium-dose maintenance inhaled corticosteroid (ICS) therapy (defined as 400-800 µg budesonide/day or equivalent) improved lung function and provided sustained bronchodilation over 24 hours in patients with moderate asthma and airflow limitation. Tiotropium is being investigated to determine the medicine’s efficacy in treating asthma patients and is not currently approved for this indication.

11 Sep 2013

Once-daily COPD portfolio data from Novartis presented at European Respiratory Society (ERS) Annual Congress

Novartis announced new analyses of data for once-daily Ultibro® Breezhaler® (investigational QVA149 - indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), which showed significant improvements in lung function, shortness of breath and health-related quality of life for chronic obstructive pulmonary disease (COPD) patients versus all comparators1,2. These data were part of 39 respiratory abstracts presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain.

9 Sep 2013

Reformulated OxyContin®: an interview with Dr. Paul Coplan, Executive Director, Risk Management and Epidemiology, Purdue Pharma

OxyContin contains oxycodone, which is an opioid agonist. It is used for the management of moderate to severe pain when a constant opioid analgesic is needed for a prolonged period of time.

29 Aug 2013

Boehringer Ingelheim completes patient enrolment of two pivotal Phase III interferon-free hepatitis C clinical trials

Boehringer Ingelheim today announced that enrolment of over 950 treatment naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso™ 1 and 2 trials is complete.

15 Aug 2013

Interferon-free treatment for genotype-1b hepatitis C patients: an interview with Professor Wulf Boecher, Boehringer Ingelheim

Genotype 1 is, worldwide, the most prevalent genotype of the hepatitis C virus. It accounts for around seventy percent of all hepatitis C infections.

30 Jul 2013

Investigational all-oral interferon-free combination from Boehringer Ingelheim achieves 95% viral cure rates in genotype-1b hepatitis C patients

New data from Boehringer Ingelheim’s interferon-free SOUND-C3 study were presented during the APASL Liver Week in Singapore. The Phase IIb study investigated the efficacy and safety of faldaprevir+ and deleobuvir+ (BI 207127) plus ribavirin in treatment-naïve patients with genotype-1b (GT-1b) hepatitis C virus (HCV),1 one of the most common types of HCV globally.2

13 Jun 2013

Faldaprevir+ achieves viral cure in 88% of treatment-naïve genotype-1 hepatitis C patients in Asia

New findings presented today during the APASL Liver Week in Singapore, highlighted the efficacy and safety of faldaprevir+ plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia.1 This post-hoc sub-analysis of the Phase III STARTVerso™1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in this particular patient group.1

10 Jun 2013

EMRs emerge as valuable resource for detecting bad drug reactions

NJIT Assistant Professor Mei Liu, PhD, a computer scientist, has recently shown in a new study that electronic medical records can validate previously reported adverse drug reactions and report new ones.

6 Jun 2013

Aclidinium and formoterol combination demonstrates significant lung function improvement in the second pivotal efficacy trial

Almirall, S.A. (ALM:MC) and Forest Laboratories, Inc. (NYSE:FRX) today announced positive topline results from AUGMENT/COPD, the second six-month pivotal phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) for the treatment of Chronic Obstructive Pulmonary Disease (COPD), delivered in the Pressair™ inhaler (Genuair® outside the USA).

2 May 2013

COPD phase III study by Almirall and Forest Laboratories announces positive results

Almirall, S.A. (ALM:MC) and Forest Laboratories, Inc. (NYSE:FRX) today announced positive topline results from a six month pivotal phase III clinical trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) delivered by Almirall’s inhaler Genuair® (Pressair™ in the USA).

16 Apr 2013

MedeAnalytics' Accountable Care Solution selected for Mississippi's MEHRS application

MedeAnalytics, a leading provider of healthcare performance management solutions, announced today that the State of Mississippi Medicaid has selected MedeAnalytics' Accountable Care Solution to empower the next generation of the state's Medicaid Electronic Health Records System application.

9 Apr 2013

LabCorp launches expanded IBD testing profile

Laboratory Corporation of America Holdings announced today the availability of an expanded testing menu to help clinicians diagnose, treat and monitor the course of Inflammatory Bowel Disease.

1 Apr 2013

Tivozanib: an interview with Stephen L. Eck, M.D., Ph.D., Vice President, Global Oncology, Astellas Pharma US, Inc. Global Development

Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor, or TKI, that is being investigated for use in patients with advanced renal cell carcinoma (RCC), or kidney cancer.

19 Mar 2013

$Bisphosphonate link to nonhealing fractures strengthened$

Bisphosphonate link to nonhealing fractures strengthened

US scientists have identified a safety signal between bisphosphonate use and nonhealing femoral fractures, possibly due to the rare side effect, atypical femur fracture.

1 Mar 2013

Pivotal study of olesoxime in Spinal Muscular Atrophy receives positive interim review

Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for under-served medical needs in neurology and cardiology, announced the completion of the interim analysis of the pivotal efficacy study of olesoxime in the rare neurodegenerative condition Spinal Muscular Atrophy (SMA).