Hypersensitivity News and Research

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

SYNERA can help prevent needle stick pain associated with superficial IVs

Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows SYNERA® (lidocaine and tetracaine) topical patch to be used at home.

4 Jun 2014

New antibody appears to block sensations of pain, itching in mouse model

Duke University researchers have found an antibody that simultaneously blocks the sensations of pain and itching in studies with mice.

23 May 2014

FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., has announced that the United States (U.S.) Food and Drug Administration (FDA) simultaneously approved a new biologic therapy, Entyvio™ (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).

21 May 2014

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

GlaxoSmithKline plc today presented data at the American Thoracic Society (ATS) from a late-stage clinical study.

20 May 2014

Innate immune response may warn of chronic multisite musculoskeletal pain

An enhanced innate immune response may be an indicator of the onset or prolongation of chronic, multisite musculoskeletal pain, cross-sectional study findings suggest.

19 May 2014

Endo acquires worldwide rights to Zogenix' sumatriptan injection

Endo International plc announced today that affiliates of the company have completed the acquisition of worldwide rights to Sumavel® DosePro® (sumatriptan injection), a needle-free delivery system for subcutaneous use, from Zogenix, Inc, for $85 million in cash and rights to additional cash payments based on the achievement of certain commercial milestones.

19 May 2014

Convenient new treatment option for rheumatoid arthritis sufferers offers patient freedom and control of disease

A new subcutaneous formulation of RoActemra® (tocilizumab) has today been launched providing thousands of UK rheumatoid arthritis (RA) patients with a potentially life-changing treatment option.1

19 May 2014

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer's Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

12 May 2014

Cumberland launches new Vaprisol product

Cumberland Pharmaceuticals Inc. today announced the launch of its active promotional campaign to support its new Vaprisol® product.

7 May 2014

AstraZeneca’s EPANOVA receives FDA approval for treatment of adults with hypertriglyceridemia

AstraZeneca today announced the US Food and Drug Administration (FDA) approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

7 May 2014

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

GE Healthcare announces commercial availability of new Alzheimer’s diagnostic tool

GE Healthcare today announced the first seven markets where Vizamyl (Flutemetamol F18 injection), a radioactive diagnostic agent approved by the FDA will be available. Late in the second quarter of 2014, Vizamyl will be available to imaging centers near East Rutherford, NJ, Woburn, MA, Beltsville, MD, East Lansing, MI, Dallas, TX, Phoenix, AZ and Colton, CA.

29 Apr 2014

GSK, Theravance announce availability of Anoro Ellipta in the US for COPD treatment

GlaxoSmithKline plc and Theravance, Inc. today announced that Anoro Ellipta (umeclidinium and vilanterol inhalation powder), the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD), is now available to retail pharmacies in the US.

28 Apr 2014

Researchers identify genetic factors that contribute to ADHD in humans

The 60 trillion cells that comprise our bodies communicate constantly. Information travels when chemical compounds released by some cells are received by receptors in the membrane of another cell.

26 Apr 2014

FDA approves GSK's Tanzeum as once-weekly treatment for type 2 diabetes

GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

16 Apr 2014

Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus.

8 Apr 2014

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).

8 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment.

31 Mar 2014

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy".

18 Mar 2014

Hypersensitivity News and Research

SYNERA can help prevent needle stick pain associated with superficial IVs

New antibody appears to block sensations of pain, itching in mouse model

FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

GSK reports positive results from Incruse Ellipta and Advair Diskus combination therapy in COPD patients

Innate immune response may warn of chronic multisite musculoskeletal pain

Endo acquires worldwide rights to Zogenix' sumatriptan injection

Convenient new treatment option for rheumatoid arthritis sufferers offers patient freedom and control of disease

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Cumberland launches new Vaprisol product

AstraZeneca’s EPANOVA receives FDA approval for treatment of adults with hypertriglyceridemia

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

GE Healthcare announces commercial availability of new Alzheimer’s diagnostic tool

GSK, Theravance announce availability of Anoro Ellipta in the US for COPD treatment

Researchers identify genetic factors that contribute to ADHD in humans

FDA approves GSK's Tanzeum as once-weekly treatment for type 2 diabetes

Access provides update on new formulation of anti-inflammatory drug amlexanox

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

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