Hypersensitivity News and Research

RSS

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

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

16 Mar 2014

AbbVie's PEARL-III study meets primary, secondary endpoints in patients with chronic GT1b HCV infection

The first detailed results from AbbVie's pivotal phase III study, PEARL-III, were presented today as part of the 21st Conference on Retroviruses and Opportunistic Infections (CROI) press conference and will also be presented as a late-breaker at the conference on March 4.

4 Mar 2014

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare.

3 Mar 2014

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

26 Feb 2014

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

25 Feb 2014

Onset Dermatologics launches 75mg strength of MINOCIN pellet-filled capsules to treat bacterial infections

Onset Dermatologics, a leader in developing and commercializing prescription products for improving skin health, today announced the launch of a 75mg strength of MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules.

25 Feb 2014

Researchers find new drug compound that treats laboratory mice with congenital heart disease

Congenital heart disease is the most common form of birth defect, affecting one out of every 125 babies, according to the National Institutes of Health. Researchers from the University of Missouri recently found success using a drug to treat laboratory mice with one form of congenital heart disease, hypertrophic cardiomyopathy - a weakening of the heart caused by abnormally thick muscle.

23 Feb 2014

Guerbet: FDA approves manufacturing plant for Lipiodol (ethiodized oil) Injection

Guerbet (GBT), the contrast agent specialist for medical imaging, today announced that it had received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol® (ethiodized oil) Injection, in Montreal, Canada.

20 Feb 2014

Forest Laboratories plans to discontinue sale of NAMENDA 5 mg and 10 mg tablets

Forest Laboratories, Inc., a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, today announced that it plans to discontinue the sale of NAMENDA (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014.

16 Feb 2014

Jazz Pharmaceuticals' Versacloz now commercially available in the U.S. for schizophrenia

Jazz Pharmaceuticals plc today announced U.S. commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.

11 Feb 2014

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