Hypersensitivity News and Research

RSS

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

FDA: New drug Tivicay approved to treat HIV-1 infection

The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply.

13 Aug 2013

Cancer-linked mitosis: an interview with Professor Scott Kern, Johns Hopkins University School of Medicine

Mitosis is the process by which a cell gives rise to two daughter cells. It’s the basis behind the growth of the human body, the renewal of the human body as it ages, and unfortunately, the growth of cancers.

7 Aug 2013

Lupin acquires exclusive license to promote, distribute Romark's Alinia for Oral Suspension in US

Romark Laboratories announced that it has entered into a strategic agreement with Lupin Limited and its subsidiaries (collectively Lupin) designed to expand promotion and distribution efforts related to its Alinia (nitazoxanide) for Oral Suspension, 100 mg/5 mL. Under the agreement, Lupin acquired an exclusive license to promote and distribute Alinia for Oral Suspension in the United States.

7 Aug 2013

Regeneron, Bayer report positive results from Phase 3 VIVID-DME and VISTA-DME trials of EYLEA for DME

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that in the Phase 3 VIVID-DME and VISTA-DME trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks.

6 Aug 2013

Forest Laboratories, Pierre Fabre Laboratories announce that FETZIMA gets FDA approval for MDD

Forest Laboratories, Inc. and Pierre Fabre Laboratories announced today that FETZIMA (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor, discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the U.S. Food and Drug Administration for the treatment of Major Depressive Disorder in adults.

26 Jul 2013

Study finds that higher-frequency electric current stimulation of the spinal cord reduces pain faster

An animal study in the August issue of Anesthesiology suggests that higher-frequency electric current stimulation of the spinal cord reduced pain quicker and better reached nerves not affected by traditionally used frequencies. A higher frequency and intensity controlled pain faster and more effectively, the study found.

25 Jul 2013

Par Pharmaceutical receives final ANDA approval for generic version of Trilipix

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid EQ 45 mg and EQ 135 mg delayed-release capsules.

19 Jul 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

Spectrum Pharmaceuticals enters into agreement to acquire Talon Therapeutics

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.

17 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

Bristol-Myers Squibb, Pfizer announce FDA acceptance of Eliquis sNDA for review

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

11 Jul 2013

Children with SPD have quantifiable differences in brain structure, reveals study

In a groundbreaking new study from UC San Francisco, researchers have found that children affected with sensory processing disorders (SPD) have quantifiable differences in brain structure, showing a biological basis for the disease that sets it apart from other neurodevelopmental disorders.

10 Jul 2013

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

From Baxter International Inc. 5 Jul 2013

Genentech's Perjeta regimen gets FDA Priority Review for HER2-positive early stage breast cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application for the use of a Perjeta (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.

2 Jul 2013

Patients with type2 diabetes, renal impairment have less hypoglycemia with JANUVIA compared to sulfonylurea

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a post-hoc pooled analysis showing patients with type 2 diabetes and mild renal impairment treated with JANUVIA- (sitagliptin) 100 mg once-daily achieved similar blood sugar reductions as those treated with the sulfonylureas glipizide or glimepiride, with significantly fewer events of hypoglycemia (low blood sugar), and with weight loss instead of weight gain.

24 Jun 2013

Bristol-Myers Squibb and AstraZeneca announce top line results of Phase 4 SAVOR-TIMI-53 clinical trial of Onglyza

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin).

20 Jun 2013

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

23 May 2013

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire plc, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association 166th Annual Meeting in San Francisco, May 18-22.

20 May 2013

Neupro reduces PLMS and total NSBP elevations in patients with RLS, study finds

UCB today announced data from a double-blind, placebo-controlled study that found that Neupro (Rotigotine Transdermal System) reduced total nocturnal systolic blood pressure elevations associated with periodic limb movements during sleep and total PLMS in patients with idiopathic moderate-to-severe Restless Legs Syndrome/Willis-Ekbom disease.

18 May 2013