Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Bayer Inc. today responded to Professor Marvin Meyer's letter to the editor, entitled: "Critical questions concerning the validity of the Bayer study report of differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration" and published in the online edition of the International Journal of Clinical Pharmacology and Therapeutics. Bayer responded to the clinical relevance of the differences in formulation and dissolution behaviour and the delayed absorption of Mylan's extended release nifedipine.

25 May 2010

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 May 2010

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

Abraxis BioScience, Inc., a fully integrated biotechnology company, previously announced it will be presenting more than 30 studies, including new clinical data evaluating the use of nanoparticle albumin bound driven chemotherapy, nab-paclitaxel (ABRAXANE for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension) for the treatment of pancreatic cancer at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago.

21 May 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.

21 May 2010

Research shows improved treatment of severe epilepsy reduces overall cost of the condition

Improved treatment of severe epilepsy could reduce the overall cost of the condition, according to research presented at the annual meeting of the International Society of Pharmacoeconomic Outcomes Research at the Hilton Atlanta in Atlanta, Georgia.

20 May 2010

Final data from Open-Label studies of Cinryze in patients with HAE now available

ViroPharma Incorporated today announced the availability of final data from Open-Label studies of Cinryze (C1 Esterase Inhibitor [Human]) in preventing and treating attacks of hereditary angioedema on the U.S. National Institutes of Health's online clinical trial registry, www.clinicaltrials.gov.

18 May 2010

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

17 May 2010

U.S. healthcare practitioners can resume use of Rotarix, says FDA

GlaxoSmithKline announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 in the vaccine poses no safety risk.

15 May 2010

Australian TGA approves Acetadote for treatment of paracetamol poisoning

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.

12 May 2010

Ferring to acquire global rights to Xanodyne Pharmaceutical's LYSTEDA

Ferring Pharmaceuticals today announced an agreement that will expand its Women's Health product portfolio with the acquisition of the global rights to Xanodyne Pharmaceutical's LYSTEDA™ (tranexamic acid), a first-in-class, non-hormonal therapy indicated specifically for treatment of women with cyclic heavy menstrual bleeding (HMB).

10 May 2010

Takeda enters co-promotion agreement with Janssen Pharma for VELCADE

Takeda Pharmaceutical Company Limited and its wholly owned subsidiary Millennium: The Takeda Oncology Company today announced that Takeda has entered into a co-promotion agreement with Janssen Pharmaceutical K.K. for VELCADE® (bortezomib) for Injection, a treatment for patients with multiple myeloma.

10 May 2010

GSK participates in FDA advisory committee's rotavirus vaccine meeting

GlaxoSmithKline today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines. Although the committee did not issue any formal recommendations, members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks associated with the presence of porcine circovirus type 1 (PCV-1) in the vaccines.

10 May 2010

SAEC, Cerner collaborate to identify genetic markers associated with drug-related SAEs

The International Serious Adverse Events Consortium (SAEC) announced today that Cerner Corporation will collaborate with this novel, international research consortium, which is working to identify genetic markers that may help predict which individuals are at risk for a range of serious drug-related adverse events (SAEs). Researchers collaborating with the SAEC will use Cerner Discovere-, Cerner's web-based research platform, to gather data for studies that focus on two SAEs: liver injury and hypersensitivity reactions.

6 May 2010

Roche announces Health Canada approval for ACTEMRA to treat RA

Roche today announced that Health Canada has approved ACTEMRA(TM) (tocilizumab) to treat patients with rheumatoid arthritis (RA), a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications, such as fatigue and anemia.

4 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

Short-term calorie restriction improves function of T-cells

Scientists funded by the Agricultural Research Service (ARS) found that volunteers who followed a low-calorie diet or a very low-calorie diet not only lost weight, but also significantly enhanced their immune response. The study may be the first to demonstrate the interaction between calorie restriction and immune markers among humans.

30 Apr 2010

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

Studies and analyses of the Crohn’s Disease (CD) treatment Cimzia® (certolizumab pegol) demonstrating new data will be exhibited at Digestive Disease Week (DDW) 2010, taking place in New Orleans from May 1-5, 2010.

30 Apr 2010

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Generex Biotechnology Corporation today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients. AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc., a wholly owned subsidiary of Generex, for multiple cancer indications.

28 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

Hypersensitivity News and Research

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Research shows improved treatment of severe epilepsy reduces overall cost of the condition

Final data from Open-Label studies of Cinryze in patients with HAE now available

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

U.S. healthcare practitioners can resume use of Rotarix, says FDA

Australian TGA approves Acetadote for treatment of paracetamol poisoning

Ferring to acquire global rights to Xanodyne Pharmaceutical's LYSTEDA

Takeda enters co-promotion agreement with Janssen Pharma for VELCADE

GSK participates in FDA advisory committee's rotavirus vaccine meeting

SAEC, Cerner collaborate to identify genetic markers associated with drug-related SAEs

Roche announces Health Canada approval for ACTEMRA to treat RA

VIMOVO delayed-release tablets receive FDA approval

Short-term calorie restriction improves function of T-cells

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

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Expanding research and clinical options for children with cancer

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