Hypersensitivity News and Research

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

TachoSil blood-clotting patch receives FDA approval for cardiovascular surgery

The U.S. Food and Drug Administration today approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical.

6 Apr 2010

Schering-Plough HealthCare Products commences promotion of ZEGERID OTC in North America

Santarus, Inc., a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc., the consumer healthcare subsidiary of Merck & Co., Inc., has commenced promotion of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its licensing agreement with Santarus for the over-the-counter (OTC) market in North America. The OTC heartburn market in the U.S. is estimated at approximately $1.8 billion based on data from market research firm Information Resources, Inc. and Santarus estimates.

2 Apr 2010

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

1 Apr 2010

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Genta Incorporated today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.

31 Mar 2010

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

ViroPharma Incorporated today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema.

31 Mar 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

Erbitux can now be used in Japan as 1st-line treatment for mCRC: Merck Serono

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Erbitux® (cetuximab) can now be used in Japan in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor -expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer carrying the KRAS wildtype gene.

29 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

Biogen Idec and Elan begin comparative trial of MS treatments

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis.

25 Mar 2010

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma Incorporated today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application for Cinryze for acute treatment and prophylaxis against hereditary angioedema, which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Pfizer to supply pneumococcal conjugate vaccines for infants and children

Pfizer Inc. today announced it has signed a 10-year Provisional Supply Agreement to supply Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]), the company’s 13-valent pneumococcal conjugate vaccine, for infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) pilot project against pneumococcal disease.

24 Mar 2010

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma Incorporated today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

19 Mar 2010

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

ViroPharma Incorporated today announced the launch of 'Ryze Above' (www.ryzeabove.com), an exclusive patient resources program within the company's patient support program, CINRYZESolutions®. The Ryze Above program was created for HAE patients prescribed Cinryze, the first and only drug specifically approved to help prevent swelling and/or painful attacks in teenagers and adults with HAE.

19 Mar 2010

AMAG Pharmaceuticals' abstract on ferumoxytol for CKD accepted for presentation at NKF 2010

AMAG Pharmaceuticals, Inc. today announced that one abstract has been accepted for presentation at the National Kidney Foundation 2010 Spring Clinical Meeting being held April 13-17, 2010 in Orlando, FL.

19 Mar 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Somaxon Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.

19 Mar 2010

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Pathway Genomics' personal Genetic Health Report now available

Pathway Genomics Inc., a U.S. based genetic testing company, announced the immediate availability of its personal Genetic Health Report. This customized and innovative personal genetic health report contains information on more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health).

17 Mar 2010

Genentech submits ACTEMRA sBLA to FDA

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).

17 Mar 2010

Hypersensitivity News and Research

TachoSil blood-clotting patch receives FDA approval for cardiovascular surgery

Schering-Plough HealthCare Products commences promotion of ZEGERID OTC in North America

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Erbitux can now be used in Japan as 1st-line treatment for mCRC: Merck Serono

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Biogen Idec and Elan begin comparative trial of MS treatments

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Pfizer to supply pneumococcal conjugate vaccines for infants and children

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

AMAG Pharmaceuticals' abstract on ferumoxytol for CKD accepted for presentation at NKF 2010

FDA approves Somaxon Pharmaceuticals' Silenor for treatment of insomnia

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Pathway Genomics' personal Genetic Health Report now available

Genentech submits ACTEMRA sBLA to FDA

Achieving and maintaining ISO/IEC 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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