Hypersensitivity News and Research

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

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Xeomin receives FDA approval for treatment of cervical dystonia

Merz Pharmaceuticals today announced that the United States Food and Drug Administration has approved Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm. According to an epidemiology study conducted in Rochester, Minnesota, the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the U.S.

2 Aug 2010

VBDS secondary to nevirapine use in HIV-positive, pregnant female: Report

Vanishing bile duct syndrome refers to a group of disorders characterized by destruction and disappearance of intrahepatic (inside the liver) bile ducts. Multiple causes have been identified including infections, malignancies, autoimmune conditions and adverse effects of medications. The usual course of this condition is variable and many patients with VBDS respond to treatment of the underlying condition and/ or removal of the offending agent. However, others progress to cirrhosis and end stage liver disease requiring liver transplantation.

31 Jul 2010

GSK anticipates to supply over 30 million doses of FLULAVAL, FLUARIX for 2010-2011 flu season

GlaxoSmithKline announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released the first lots of FluLaval® [Influenza Virus Vaccine] allowing distribution in the U.S. to begin for the 2010-2011 flu season. GSK anticipates distribution of Fluarix® [Influenza Virus Vaccine] to follow in the next several weeks.

30 Jul 2010

$Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released$

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.

30 Jul 2010

Researchers discover enzyme crucial for DNA repair

Researchers have discovered an enzyme crucial to a type of DNA repair that also causes resistance to a class of cancer drugs most commonly used against ovarian cancer.Scientists from The University of Texas MD Anderson Cancer Center and the Life Sciences Institute of Zhejiang University in China report the discovery of the enzyme and its role in repairing DNA damage called cross-linking in the Science Express advance online publication of Science.

30 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Rotigotine provides clinically relevant improvements in RLS symptoms: Study

UCB today announced the results of a 6-month, randomized, double-blind, placebo-controlled clinical study, published in the journal Movement Disorders, showing that Neupro® (rotigotine transdermal system, 2 and 3 mg/24 hours) provided sustained, clinically relevant improvements in symptoms of Restless Legs Syndrome (RLS). The study also showed high rates of complete remission seen with rotigotine 2 mg or 3 mg/24 hours.

29 Jul 2010

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2010. For the second quarter, AMAG reported total revenue of $18.8 million, including $16.0 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues.

29 Jul 2010

Dyax second-quarter total revenues increase to $15.1 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Dyax Corp. today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

20 Jul 2010

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL).

19 Jul 2010

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

GTC Biotherapeutics, Inc. announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark.

17 Jul 2010

First-of-its-kind patient, healthcare provider support program for management of HE

Concentric Pharma Advertising, an independent healthcare advertising and marketing agency, announces the creation of Salix Pharmaceuticals' Hepatic Encephalopathy Living Program. H.E.L.P. launched May 24, 2010, and coincides with the launch of Xifaxan550 (rifaximin) for the management of patients 18 or older at risk for overt hepatic encephalopathy recurrence.

16 Jul 2010

Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the launch of its ultrasound contrast imaging agent, DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India. The company has signed a multi-year agreement with Mumbai-based J.B. Chemicals & Pharmaceuticals, Ltd. for the distribution and marketing of DEFINITY® in the Indian marketplace.

15 Jul 2010

New REMESENSE TOOTH DESENSITIZER for treating tooth hypersensitivity

Nuline Pharmaceuticals, LLC announces the introduction of REMESENSE (dipotassium oxalate 3%) TOOTH DESENSITIZER, an Rx Class II medical device now available in the U.S. REMESENSE was introduced globally in 2008. It is presently sold in 16 countries, ranging from England and the European Union to Asia and Africa. Nuline expects to launch REMESENSE in Canada and other countries later this year or by early 2011.

15 Jul 2010

Hypersensitivity News and Research

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Xeomin receives FDA approval for treatment of cervical dystonia

VBDS secondary to nevirapine use in HIV-positive, pregnant female: Report

GSK anticipates to supply over 30 million doses of FLULAVAL, FLUARIX for 2010-2011 flu season

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Researchers discover enzyme crucial for DNA repair

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Rotigotine provides clinically relevant improvements in RLS symptoms: Study

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

Dyax second-quarter total revenues increase to $15.1 million

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

First-of-its-kind patient, healthcare provider support program for management of HE

Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

New REMESENSE TOOTH DESENSITIZER for treating tooth hypersensitivity

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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