Hypersensitivity News and Research

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

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Ethicon launches OMNEX Surgical synthetic sealant

Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON™ OMNEX™ Surgical Sealant, ETHICON™ Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON™ OMNEX™ Surgical Sealant.

8 Jul 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

European Commission approves new indication for ORENCIA in combination with MTX for RA

Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.

7 Jul 2010

US WorldMeds launches Revonto for malignant hyperthermia

US WorldMeds is proud to announce the launch of Revonto™ (dantrolene sodium for injection), the first patented scientific advancement in the treatment of malignant hyperthermia (MH). The time to reconstitute dantrolene sodium for injection has been dramatically reduced to approximately 20 seconds or until the solution is clear. Revonto™ retains the cost-savings of the original dantrolene sodium for injection product while offering a significant improvement in pharmacotherapy.

7 Jul 2010

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Fera Pharmaceuticals is pleased to announce the launch of Neptazane (Methazolamide) 25 mg and 50 mg tablets. Both strengths are available in 90 count bottles.

3 Jul 2010

Strativa receives FDA approval for Zuplenz oral soluble film

Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

3 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.

2 Jul 2010

Survey: 66% of patients with metastatic colorectal cancer are now tested for KRAS

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has revealed new results from a global survey demonstrating that 66% of patients with metastatic colorectal cancer (mCRC) are now tested for KRAS to determine if they could benefit from a personalized therapy, such as Erbitux® (cetuximab). This represents a 50% increase in levels of KRAS testing in just one year.

1 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Bortezomib may offer hope for treating inflammatory diseases: New research

Those looking for a new treatment for a range of inflammatory diseases like arthritis, multiple sclerosis, inflammatory bowel disease, and lupus may need to look no further than a drug already available for treating cancer. In a research report published in the July 2010 print issue of the Journal of Leukocyte Biology, Japanese scientists use mice to show that bortezomib, currently used to treat cancers that affect white blood cells, induces cell death only in harmful (active and proliferating) T cells, leaving the rest unharmed.

1 Jul 2010

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

New long term data showed that Vimpat- (lacosamide) C-V provided sustained reduction in seizure frequency for up to five years when used as an add-on treatment for uncontrolled partial onset seizures in adults with epilepsy. In addition post-hoc exploratory analyses showed that adjunctive lacosamide treatment reduced partial-onset seizure frequency and improved responder rates when added to a broad range of antiepileptic drugs (AEDs) including both traditional sodium channel-blocking agents and those that act on non-sodium channel-targets.

30 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

28 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

28 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV (velaglucerase alfa), the company's enzyme replacement therapy for the treatment of type 1 Gaucher disease.

28 Jun 2010

Bayer signs agreement to supply Adalat XL product to Teva Canada

Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat XL (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat XL exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat XL product.

28 Jun 2010

Hypersensitivity News and Research

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Ethicon launches OMNEX Surgical synthetic sealant

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

European Commission approves new indication for ORENCIA in combination with MTX for RA

US WorldMeds launches Revonto for malignant hyperthermia

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Strativa receives FDA approval for Zuplenz oral soluble film

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Survey: 66% of patients with metastatic colorectal cancer are now tested for KRAS

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Bortezomib may offer hope for treating inflammatory diseases: New research

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck challenges New York jury decision in federal FOSAMAX retrial

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Bayer signs agreement to supply Adalat XL product to Teva Canada

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