Hypersensitivity News and Research

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

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.

3 Feb 2011

Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL in males were published in the February 3 issue of the New England Journal of Medicine.

3 Feb 2011

DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011

The Company announced that the University of Rochester in concert with ADEPT has selected the study results from the KRN5500 Phase 2 study to be presented at its March 25-26, 2011 conference. The presentation is entitled, "Management of Placebo Response in a Randomized Trial of KRN5500 in Patients with Neuropathic Pain and Cancer."

2 Feb 2011

AVANIR's NUEDEXTA for pseudobulbar affect now available by prescription

AVANIR Pharmaceuticals, Inc. today announced that NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) is now available by prescription in the United States. NUEDEXTA is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for pseudobulbar affect (PBA).

1 Feb 2011

Histamine can be an important molecule to develop new treatments for MS

If you think histamines are your nemesis during allergy season, here's something that might change your perspective. New research published in the Journal of Leukocyte Biology shows that histamine could be an important molecule to developing new treatments for multiple sclerosis.

1 Feb 2011

FDA approves GRALISE Tablets for treatment of PHN

Depomed, Inc. today announced that US FDA has approved GRALISE (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia, which is pain following healing of the rash associated with shingles.

29 Jan 2011

Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients. A Phase III study published in the peer-reviewed journal Pain Practice concluded that IV ibuprofen significantly reduced both morphine use and self-reported pain intensity in patients recovering from abdominal hysterectomy compared to morphine alone.

27 Jan 2011

PediatRx announces first-ever revenues and successful launch of GRANISOL

PediatRx Inc.is pleased to provide an update on activities for the fiscal third quarter. Among its achievements, the hospital specialty pharmaceutical company reported its first-ever revenues and successfully launched GRANISOL™, the company's first commercial entry.

24 Jan 2011

Novation, Lantheus Medical to distribute ABLAVAR and DEFINITY diagnostic imaging agents

Lantheus Medical Imaging, a worldwide leader in diagnostic medical imaging, today announced a national contract with Novation for ABLAVAR and DEFINITY Vial For Injectable Suspension, providing increased access to these important diagnostic imaging agents for health care providers served by Novation.

23 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

FDA approves Cumberland's Acetadote Injection

Cumberland Pharmaceuticals today announced that it has received approval from the U.S. Food and Drug Administration for a new formulation of Acetadote Injection, the Company's product used to treat acetaminophen poisoning.

13 Jan 2011

Adjunctive lacosamide reduces seizures and improves responder rates

Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for patients with partial-onset seizures, regardless of the type of concomitant AED used, have been published in the drug evaluation journal, CNS Drugs.

13 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

DAPT shows positive outcomes following treatment with OrbusNeich's Genous Stent

Data from patients who are considered high-risk due to underlying clinical conditions and who cannot be treated with drug eluting stents and the accompanying requirement of long-term dual antiplatelet therapy showed positive safety and short- and long-term clinical outcomes following treatment with OrbusNeich's Genous Stent, according to a study published online in EuroIntervention.

11 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

EUSA receives FDA Priority Review status for ERWINAZE BLA

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that its Biologics License Application for ERWINAZE(R) has been accepted for filing and awarded Priority Review status by the U.S. Food and Drug Administration.

5 Jan 2011