Hypersensitivity News and Research

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

Vernalis Therapeutics announces availability of codeine-based cough and cold syrup in the U.S.

Vernalis Therapeutics Inc., a subsidiary of Vernalis plc, today announced that Tuzistra XR (codeine polistirex and chlorpheniramine polistirex), extended-release oral suspension, CIII (DEA Schedule III) is now available to adult patients and physicians in the United States.

8 Sep 2015

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

Allergan plc. today announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis.

2 Sep 2015

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Allergan plc today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

2 Sep 2015

Egalet to present scientific data on SPRIX Nasal Spray at Painweek 2015

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on discovering, developing, and commercializing innovative pain treatments, today announced that researchers will be presenting scientific data on SPRIX (ketorolac tromethamine) Nasal Spray, Egalet-001, an abuse-deterrent, extended-release, oral morphine product candidate, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone product in development, at PainWeek 2015 to be held September 8 to 12 in Las Vegas, Nevada.

1 Sep 2015

Scientists elucidate chemical process behind eosinophilic esophagitis

Scientists from the D'Or Institute of Research and Education, the Federal University of Rio de Janeiro and the Yale University School of Medicine have elucidated the chemical process behind a mysterious gastrointestinal disease that is becoming more frequent every day: the eosinophilic esophagitis (EoE), also known as the "asthma of the esophagus".

1 Sep 2015

Passport Health participates in clinical study to test effects of oral typhoid vaccination

Passport Health, in partnership with vaccine manufacturer PaxVax, Inc. is participating in a clinical study to test the effects of the oral typhoid vaccination, Vivotif (Typhoid Vaccine Live Oral Ty21a). The study will look at the side effects that could occur when taking Vivotif across the range of approved potencies.

28 Aug 2015

Amgen to present data on Repatha (evolocumab) and observational studies at ESC Congress 2015

Amgen today announced that it will present six abstracts at the upcoming ESC Congress 2015, organized by the European Society of Cardiology, being held Aug. 29 – Sept. 2 in London.

26 Aug 2015

Shire enters into agreement with Sanquin for CINRYZE

Shire plc announced today it has entered into an agreement with Sanquin Blood Supply, the manufacturer of CINRYZE (C1 esterase inhibitor [human]), providing Shire access to its manufacturing technology and allowing Shire to source additional manufacturers to meet the growing demand for CINRYZE.

25 Aug 2015

Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira today announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS).

20 Aug 2015

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).

17 Aug 2015

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Veloxis Pharmaceuticals A/S, today announced that Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorization from the FDA on July 10, 2015.

14 Aug 2015

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