Hypersensitivity News and Research

RSS

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

FDA approves Novartis’ Exelon Patch to treat mild to moderate AD

The US Food and Drug Administration has approved a higher dose of Exelon Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease.

4 Sep 2012

Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet strength of EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

Healthcare announces important changes to the U.S. product label for Optison

GE Healthcare today announced important changes to the U.S. product label for Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to diagnose certain heart diseases such as hypertrophic cardiomyopathy.

22 Aug 2012

Social phobia prevalent in OCD patients

Social phobia is common among patients with obsessive compulsive disorder and frequently co-occurs with other related disorders, researchers report.

21 Aug 2012

Common antibiotics may risk liver injury in elderly

Regulatory warnings should be considered for the antibiotics moxifloxacin and levofloxacin because of a potential risk for liver injuries in the elderly, Canadian researchers suggest.

14 Aug 2012

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

12 Aug 2012

FDA approves Mylan's ANDA for generic Provigil

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg.

10 Aug 2012

Alfa Wassermann, Salix enter license agreement for EIR formulation of rifaximin

Salix Pharmaceuticals, Ltd. and Alfa Wassermann S.p.A. today announced that they have entered into an exclusive agreement by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin for gastrointestinal and respiratory indications, including Crohn's disease.

9 Aug 2012

Cardionovum to introduce PROLIMUS Biograde system in Europe

Cardionovum GmbH announced today that it expects to launch in Europe in Q4 2012 a next-generation Sirolimus-eluting coronary stent system—PROLIMUS Biograde—which is designed to optimize long-term patient results. Unlike many state-of-the-art DES that are currently being marketed, PROLIMUS Biograde provides multiple pro-healing product features to promote early re-endothelialization.

9 Aug 2012

Elimination diet may help manage cow's milk protein allergy in infants

Cow's milk protein allergy (CMPA), although difficult to diagnose in young children, shows a causative relationship to otolaryngic symptoms. A new study in the August journal, Otolaryngology-Head and Neck Surgery suggests an elimination diet may help manage such conditions in children under two and reduce the need for more serious upper airway tests and interventions.

8 Aug 2012

Australia's top medical researchers for 2012 announced

Finalists for one of Australia’s longest running and most prestigious awards for medical research were announced today. This year’s winner will join a list of alumni winners that includes many of the country’s most respected scientists.

31 Jul 2012

Positive results from XIAFLEX phase IIIb multicord trial for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company enrolled 60 patients at eight sites throughout the U.S. and Australia.

30 Jul 2012

EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

28 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

FDA approves Forest Laboratories’ Tudorza Pressair to treat COPD

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

24 Jul 2012

Once-daily Gralise significantly reduces pain intensity in PHN patients

Depomed, Inc. today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).

23 Jul 2012

Top-line results in Pfizer's Lyrica long term safety study for Generalized Anxiety Disorder

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules Study A0081147 - Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) - demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients.

23 Jul 2012

Regeneron, Sanofi initiate enrollment in SAR236553/REGN727 Phase 3 program

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that several trials within ODYSSEY, the Phase 3 clinical program of SAR236553/REGN727, have initiated patient enrollment.

21 Jul 2012

Delaware district court upholds Pfizer's patents for LYRICA to treat pain and seizures

Pfizer Inc. announced today that the United States District Court for the District of Delaware upheld its composition of matter patent and pain and seizure use patents covering LYRICA (pregabalin) capsules CV. With this decision, Pfizer will exclusively provide pregabalin as LYRICA to patients through December 30, 2018 in the U.S., pending generic company appeal and further litigation.

20 Jul 2012