Hypersensitivity News and Research

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

Lilly, Boehringer Ingelheim to present latest data from diabetes portfolio at 47th EASD meeting

Boehringer Ingelheim and Eli Lilly and Company will present the latest data from their diabetes portfolio at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal, September 12-16.

8 Sep 2011

Researchers discover mechanism of low-dose LDN on cell proliferative-related disorders

Researchers at The Pennsylvania State University College of Medicine, Hershey, Pennsylvania have discovered the mechanism by which a low dose of the opioid antagonist naltrexone (LDN), an agent used clinically to treat cancer and autoimmune diseases, exerts a profound inhibitory effect on cell proliferation.

3 Sep 2011

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011

BIPI to launch dabigatran etexilate Phase II trial in patients with mechanical heart valves

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced plans to launch RE-ALIGN, a global, Phase II trial evaluating the safety and pharmacokinetics of dabigatran etexilate in 400 patients who have mechanical heart valves.

26 Aug 2011

Spinifex secures AU$6.25 million in expanded Series B funding

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

23 Aug 2011

Santarus, Depomed enter new commercialization agreement for GLUMETZA

Santarus, Inc. and Depomed, Inc. today announced that they have entered into a new commercialization agreement for GLUMETZA (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008.

23 Aug 2011

Mercury and autism link strengthened

The researchers from Swinburne University in Melbourne surveyed 522 Australian survivors of Pink disease - a form of mercury poisoning common in the early 20th century - found one in 25 of their 398 grandchildren aged six to 12 had an autism spectrum disorder.

10 Aug 2011

Research shows six-fold risk of autism in grandchildren of acrodynia survivors

Researchers from Australia have identified an ancestry of Pink Disease (Infantile Acrodynia) as a risk factor for Autism Spectrum Disorders.

10 Aug 2011

FDA approves Covidien's morphine sulfate oral solution for chronic pain in opioid-tolerant patients

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) recently granted approval to the company's Mallinckrodt business for morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients. The solution will be available as a generic in 100 milligrams per 5 mL (20 milligrams per 1 mL).

1 Aug 2011

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.

30 Jul 2011

Cadence confirms FDA dosing recommendations for OFIRMEV

Cadence Pharmaceuticals, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) approved dosing recommendations for OFIRMEV (acetaminophen) injection remains 4,000 mg per day for adults and adolescents weighing at least 50 kg.

29 Jul 2011

Merck secures worldwide rights to vernakalant i.v.

Merck, known as MSD outside the United States and Canada, and Astellas US LLC, the U.S. subsidiary of Astellas Pharma Inc. today announced that they have entered into an agreement under which Merck, through a subsidiary, will acquire the exclusive rights to develop and commercialize the investigational intravenous formulation of vernakalant (vernakalant i.v.) in Canada, Mexico and the United States from Astellas.

27 Jul 2011

Baxter GAMMAGARD LIQUID for PI receives FDA approval for subcutaneous administration

Baxter International Inc. announced today that the U.S. Food and Drug Administration has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency.

From Baxter International Inc. 25 Jul 2011

FDA approves Merz Aesthetics' XEOMIN for temporary improvement of glabellar lines

Merz Aesthetics today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved XEOMIN for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.

22 Jul 2011

FDA approves Cephalon's REMS for FENTORA, ACTIQ

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA and ACTIQ.

22 Jul 2011

AMAG enters definitive merger agreement with Allos Therapeutics

AMAG Pharmaceuticals, Inc. and Allos Therapeutics, Inc. today announced that they have entered into a definitive merger agreement under which the companies will combine in an all-stock merger with a total equity value of approximately $686 million.

21 Jul 2011

New corticosteroid with cream-like base

Upsher-Smith Laboratories, Inc. announced the launch of Trianex 0.05% (Triamcinolone Acetonide Ointment), a prescription topical corticosteroid offering the feel of a cream with the strength of an ointment.

11 Jul 2011

FDA approves BOOSTRIX to prevent tetanus, diphtheria and pertussis in older people

The U.S. Food and Drug Administration (FDA) has approved BOOSTRIX for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria and pertussis.

11 Jul 2011

PENNSAID Viscous Solution Phase 2 clinical trial for osteoarthritis pain meets primary endpoint

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the treatment of pain, today announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of top-line results from a Phase 2 study conducted by Covidien, of twice-daily administration of PENNSAID Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel.

30 Jun 2011

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

In a new post-hoc analysis based on the American Association of Clinical Endocrinologists (AACE/ACE) diabetes algorithm presented at the American Diabetes Association (ADA) 71st Annual Scientific Sessions, significantly more patients with type 2 diabetes treated with JANUMET-tablets achieved blood sugar goals after 18 weeks compared to metformin as initial therapy.

27 Jun 2011