Hypersensitivity News and Research

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

Mallinckrodt's subsidiary to acquire all outstanding shares of Cadence Pharmaceuticals

Mallinckrodt plc, a leading global specialty pharmaceuticals company, and Cadence Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt plc will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals, Inc. for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis, which represents a 32% premium to the trailing 30-trading-day volume weighted average price (VWAP) of $10.62 per share for Cadence Pharmaceuticals, Inc.

11 Feb 2014

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees.

10 Feb 2014

University of Liverpool receives funding to continue reducing impact of adverse reactions to medicinal drugs

The Medical Research Council (MRC) Centre for Drug Safety Science at the University of Liverpool has received three million pounds of new funding from MRC to allow it to continue reducing the impact of adverse reactions to medicinal drugs.

30 Jan 2014

Mylan Pharmaceuticals launches Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg. This product is the generic version of Novo Nordisk's Prandin, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

24 Jan 2014

European Commission approves ViiV Healthcare's Tivicay for treatment of HIV infected adults

ViiV Healthcare today announced that the European Commission has approved Tivicay (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.

21 Jan 2014

Gilead Sciences gets marketing authorization from European Commission for Sovaldi 400 mg tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C infection in adults, in combination with other antiviral agents (ribavirin and pegylated interferon alpha (peg-IFN)).

18 Jan 2014

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s).

17 Jan 2014

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

15 Jan 2014

FDA approves Farxiga tablets to improve glycemic control in adults with type 2 diabetes mellitus

AstraZeneca and Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

13 Jan 2014

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.