Abdominal Pain News and Research

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Abdominal pain is traditionally described by its chronicity (acute or chronic), its progression over time, its nature (sharp, dull, colicky), its distribution (by various methods, such as abdominal quadrant (left upper quadrant, left lower quadrant, right upper quadrant, right lower quadrant) or other methods that divide the abdomen into nine sections), and by characterization of the factors that make it worse, or alleviate it.

Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

Today, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG sued Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals LLC, and Barr Laboratories, Inc. in the Northern District of Illinois (Chicago) for false advertising and patent infringement in connection with Teva's generic oral contraceptive, Gianvi™. Teva's product is sold as a generic version of Bayer HealthCare's leading oral contraceptive YAZ®.

16 Jun 2010

FDA cautions on infant overdose risk with liquid Vitamin D

The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.

16 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

New research evaluating substantial disease burden of PNH presented at European Hematology Association

Alexion Pharmaceuticals, Inc. today announced new research evaluating the substantial disease burden of paroxysmal nocturnal hemoglobinuria, an ultra-rare blood disorder, in patients worldwide. The International PNH Registry, involving 580 patients from 99 sites in 14 countries as of May 2010, found that the debilitating symptoms and life-threatening complications of PNH are similar across patient populations around the world.

14 Jun 2010

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colorectal cancer.

10 Jun 2010

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Disease is a private matter to many of us. For many reasons, we want to keep it to ourselves, and no cluster of disorders challenges patients' need for privacy more than inflammatory bowel disease.

10 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Inquiry into the hospital acquired killer bug starts

A Second World War veteran John Boyle died of Clostridium difficile infection after being admitted to hospital for the first time at the age of 90. He was diagnosed with the infection on January 25 this year and succumbed to it two weeks later. He was one of 18 patients to die at a Scottish hospital when the outbreak of this hospital-acquired infection was reported.

8 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Novartis Pharmaceuticals Corporation announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 75% of patients experienced a reduction of 30% or greater in the size of their brain tumors from baseline to six months (p<0.001).

7 Jun 2010

Amgen to present Phase 2 study data of AMG 479 in metastatic pancreatic cancer at 2010 ASCO

Amgen today announced results from a small, randomized, placebo-controlled Phase 2 study indicating that adding AMG 479 to gemcitabine improved overall survival at six months (primary endpoint) and progression-free survival in patients with metastatic pancreatic cancer. The study, which also included a separate arm of conatumumab plus gemcitabine, is being presented in a Poster Discussion at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting.

5 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Tioga commences dosing in Phase 3 trial of asimadoline for diarrhea-predominant irritable bowel syndrome

Tioga Pharmaceuticals, Inc. announced today that the company has dosed its first subject in a Phase 3 clinical trial to evaluate asimadoline for the treatment of patients with diarrhea-predominant irritable bowel syndrome (DIBS). The trial, referred to as ASMP3001, is the first of two Phase 3 trials being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for U.S. registration. This first trial will be conducted at 120 sites in the U.S.

4 Jun 2010

Delaying cholecystectomy in elderly patients can increase cost and mortality

New research findings published in the May issue of the Journal of the American College of Surgeons indicate that delaying cholecystectomy, the surgical removal of the gallbladder, in elderly patients with sudden inflammation of the organ often results in increased costs, morbidity and mortality.

3 Jun 2010

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Novartis Pharmaceuticals Corporation announced today that a Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint, showing the drug significantly extended progression-free survival, or time without tumor growth, in patients with advanced pancreatic neuroendocrine tumors.

3 Jun 2010

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

Eisai Inc. (Headquarters: Woodcliff Lake, NJ; Chairman and CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration has accepted Eisai's New Drug Application for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease, and for the treatment of symptomatic GERD.

3 Jun 2010

FDA warns consumers not to purchase or use Arrow Brand Medicated Oil & Embrocation

The U.S. Food and Drug Administration today warned consumers not to purchase or use a product called "Arrow Brand Medicated Oil & Embrocation," also labeled as "Aceite Medicinal La Flecha (Spanish) or "箭嘜驅風油 (Mandarin)." The product is potentially toxic and contains two substances, methyl salicylate and camphor, which are poisonous when ingested.

29 May 2010

Stanford Hospital & Clinics uses endovascular laser technology to retrieve permanently embedded IVC filters

Over the years, Susan Karnstedt had gotten used to the intermittent pain in her abdomen, chalking it up to her diet, or perhaps to her physically active lifestyle, as a water skier and yoga enthusiast.

28 May 2010

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD), according to the National Institute of Mental Health (NIMH). New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

26 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Abdominal Pain News and Research

Further Reading

Bayer sues Teva, Barr in connection with oral contraceptive Gianvi

FDA cautions on infant overdose risk with liquid Vitamin D

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

New research evaluating substantial disease burden of PNH presented at European Hematology Association

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Cognitive-behavioral, skills-based treatment intervention program shows promise for teenagers with IBD

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Inquiry into the hospital acquired killer bug starts

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Amgen to present Phase 2 study data of AMG 479 in metastatic pancreatic cancer at 2010 ASCO

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Tioga commences dosing in Phase 3 trial of asimadoline for diarrhea-predominant irritable bowel syndrome

Delaying cholecystectomy in elderly patients can increase cost and mortality

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

FDA warns consumers not to purchase or use Arrow Brand Medicated Oil & Embrocation

Stanford Hospital & Clinics uses endovascular laser technology to retrieve permanently embedded IVC filters

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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