Hypersensitivity News and Research

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

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

Impax sells U.S. rights to Daraprim brand for $55 million to Turing Pharmaceuticals

Impax Laboratories, Inc. today announced that it has sold its U.S. rights to the Daraprim brand to Turing Pharmaceuticals AG for approximately $55 million.

10 Aug 2015

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the U.S. from Impax Laboratories, Inc. The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis.

10 Aug 2015

Study reveals new gene that plays crucial role in ASD

A study carried out by the Laboratoire Neurobiologie des Interactions Cellulaires et Neurophysiopathologie (CNRS/Aix-Marseille Université), in collaboration with clinicians from Marseilles Public Hospitals (AP-HM) and scientists from the Salk Institute in San Diego (US), has revealed a new gene that plays a crucial role during early development in humans and whose under-expression may induce certain autistic traits.

4 Aug 2015

Novel 3D human skin tissue model could help detect presence of known skin sensitizers in medical device extracts

New research shows that exposing a 3D human skin tissue model to extracts of medical device materials can detect the presence of sensitizers known to cause an allergic response on contact in some individuals. Conventional skin sensitization testing of medical devices relies on animal testing, whereas human skin models could replace animal methods, according to an article in the new journal Applied In Vitro Toxicology, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.

30 Jul 2015

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

New article examines nutritional needs of individuals with autism spectrum disorder

About 1 in 88 children has an autism spectrum disorder. This represents a 78% increase in the incidence of autism spectrum disorder since 2002 (although some of the increase may be due to improved diagnostic capabilities). Individuals with an autism spectrum disorder may have poor nutrition because they often exhibit selective eating patterns as well as sensory sensitivity that predispose them to restrict their diets.

16 Jul 2015

Hiroshima University researchers reveal molecular mechanisms involved in neuropathic pain

A research group from Hiroshima University demonstrated that the downregulation of spinal astrocyte connexin43 (Cx43) expression causes sustained neuropathic pain following peripheral nerve injury. Controlling the Cx43 expression using pharmacological approaches or gene therapy might serve as novel therapeutic strategies ameliorate neurological disorders in general and neuropathic pain in particular.

14 Jul 2015

Envarsus XR receives FDA approval for treatment of kidney transplant recipients

Veloxis Pharmaceuticals A/S today announced U.S. Food and Drug Administration approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.

11 Jul 2015

Vanderbilt receives $12.8 million federal grant to develop better ways to predict effects of drugs in patients

Vanderbilt University Medical Center has received a five-year, $12.8 million grant from the federal government to develop better ways to predict how patients will respond to the drugs they're given.

10 Jul 2015

New research reveals that male and female mice use different cells to process pain

New research released today in Nature Neuroscience reveals for the first time that pain is processed in male and female mice using different cells. These findings have far-reaching implications for our basic understanding of pain, how we develop the next generation of medications for chronic pain—which is by far the most prevalent human health condition—and the way we execute basic biomedical research using mice.

30 Jun 2015

MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) today announced that on 22 June the European Commission approved SIMPONI (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA).

26 Jun 2015

Basilea announces UK launch of broad-spectrum Cephalosporin Zevtera for first-line treatment of pneumonia

Basilea Pharmaceutica AG today announces the UK launch of its broad-spectrum Cephalosporin Zevtera (Ceftobiprole medocaril) for the first-line treatment of serious bacterial pneumonia.

25 Jun 2015

GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GlaxoSmithKline announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18).

25 Jun 2015

Findings could lead to treatments for chronic pain caused by nerve damage

Non-narcotic treatments for chronic pain that work well in people, not just mice, are sorely needed. Drawing from human pain genetics, an international team led by Boston Children's Hospital demonstrates a way to break the cycle of pain hypersensitivity without the development of addiction, tolerance or side effects.

18 Jun 2015

Research: Interaction between cortical and subcortical brain regions highlights role of hypersensitivity in ASD

The increased interaction between cortical and subcortical brain regions highlights the central role of hypersensitivity and other sensory symptoms in defining Autism Spectrum Disorder (ASD).

12 Jun 2015

Switching from Remicade to Inflectra benefits patients with rheumatic diseases

Hospira, Inc., a global leader in biosimilars, today announced the results of an independent clinical study, showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Remicade™ to Inflectra.

10 Jun 2015

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza 0.9 mg after 52 weeks of treatment. Eli Lilly and Company will present these data at the 75th American Diabetes Association Scientific Sessions in Boston.

7 Jun 2015

New study reports that poor sleep habits increase pain in knee OA

A new study reports that patients with knee osteoarthritis (OA) who have poor sleep habits display greater central sensitization--an amplification of clinical pain. Findings published in Arthritis Care & Research, a journal of the American College of Rheumatology, further show OA patients who catastrophize--consumed by thoughts of pain--had increased central sensitization that was associated with greater clinical pain.

4 Jun 2015

Helsinn's Akynzeo for CINV prevention receives EC approval

Helsinn, the Swiss Group focused on building quality cancer care, announces today that on 27th May 2015, the European Commission (EC) approved Akynzeo® (netupitant-palonosetron) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in the European Union.

2 Jun 2015