Hypersensitivity News and Research

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

Merck announces FDA approval of ISENTRESS for oral suspension

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration recently approved ISENTRESS for oral suspension, a new pediatric formulation of Merck's integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

9 Jan 2014

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today it has entered into a distribution agreement for Lymphoseek (technetium Tc 99m tilmanocept) Injection in Taiwan with Global Medical Solutions Taiwan, Ltd., a leading in-country distributor of nuclear medicine and diagnostic imaging products.

7 Jan 2014

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014

Amneal launches generic Esomeprazole strontium delayed-release capsules 49.3 mg

Amneal Pharmaceuticals LLC today announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. This new esomeprazole therapy is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium (esomeprazole magnesium) and presents a potentially more affordable treatment option for GERD in adult patients.

6 Jan 2014

Scientists discover new class of cells expressing olfactory receptors in human airways

Your nose is not the only organ in your body that can sense cigarette smoke wafting through the air. Scientists at Washington University in St. Louis and the University of Iowa have showed that your lungs have odor receptors as well.

3 Jan 2014

European Commission approves update of Erbitux to treat patients with RAS wild-type mCRC

Merck Serono, the biopharmaceutical division of Merck, today announced that the European Commission has approved the Type II variation to amend the Erbitux(cetuximab) product information, updating the indication for Erbitux to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC).

23 Dec 2013

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

From Baxter International Inc. 20 Dec 2013

Shades of gray in QoL measures after dental whitening

A complex picture has emerged of changes in oral-health-related quality of life after at-home dental bleaching, with some measures improving and others deteriorating after the treatment, a Brazilian double-blind randomized clinical trial has shown.

19 Dec 2013

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted for standard review the Company's supplemental Biologics License Application for EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema.

18 Dec 2013

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has submitted a Supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for the marketing and sale of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month.

17 Dec 2013

Amneal's Esomeprazole Strontium 49.3 mg delayed-release capsules now available for GERD patients

Amneal Pharmaceuticals LLC today announced the launch of its branded Esomeprazole Strontium 49.3 mg delayed-release capsules. Esomeprazole Strontium contains the same active moiety (esomeprazole) in a different salt form as found in the branded proton-pump inhibitor Nexium (esomeprazole magnesium) and is a new option for adult patients for the short term treatment of gastroesophageal reflux disease.

17 Dec 2013

Ipsen reports positive initial results from Dysport phase III study in Adult Upper Limb spasticity

Ipsen today announced positive initial results from the double-blind phase III study of Dysport (abobotulinumtoxinA) in Adult Upper Limb spasticity. Regarding the primary endpoints, treatment with Dysport showed statistically significant response versus placebo in the improvement of muscle tone, as measured by the Modified Ashworth Scale.

17 Dec 2013

Research findings could provide better understanding of anxiety disorders

In a new study published today in Science, John McGann, associate professor of behavioral and systems neuroscience in the Department of Psychology, and his colleagues, report that neurons in the noses of laboratory animals reacted more strongly to threatening odors before the odor message was sent to the brain.

13 Dec 2013

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

EMA expands administration options for Hizentra

CSL Behring UK Ltd announced today that the European Medicines Agency (EMA) has expanded the administration options for Hizentra®▼, human normal immunoglobulin, SCIg, 20% liquid, to include dosing once every two weeks (fortnightly).

5 Dec 2013

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.

3 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

Regeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion from the Japanese Ministry of Health, Labour and Welfare.

22 Nov 2013

Hypersensitivity News and Research

Merck announces FDA approval of ISENTRESS for oral suspension

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Amneal launches generic Esomeprazole strontium delayed-release capsules 49.3 mg

Scientists discover new class of cells expressing olfactory receptors in human airways

European Commission approves update of Erbitux to treat patients with RAS wild-type mCRC

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Shades of gray in QoL measures after dental whitening

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Amneal's Esomeprazole Strontium 49.3 mg delayed-release capsules now available for GERD patients

Ipsen reports positive initial results from Dysport phase III study in Adult Upper Limb spasticity

Research findings could provide better understanding of anxiety disorders

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Navidea receives Fast Track designation for Lymphoseek injection

EMA expands administration options for Hizentra

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Merck announces approval of NOXAFIL delayed-release tablets by FDA

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

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