Hypersensitivity News and Research

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

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

Salix Pharmaceuticals and Pharming Group NV announced today that the U.S. Food and Drug Administration has granted 12 years of exclusivity to RUCONEST (C1 esterase inhibitor [recombinant]) 50 IU/kg.

8 Oct 2015

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan plc today announced that its infectious disease portfolio will be featured in 13 abstracts highlighting data at IDWeek 2015, which takes place from October 7-11, 2015, in San Diego.

8 Oct 2015

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Biogen (NASDAQ: BIIB) will, this week, present data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, demonstrating the efficacy and safety of TECFIDERA® (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS).

7 Oct 2015

Occupational exposure to metalworking fluid associated with irreversible lung disease

Occupational exposure to fluid commonly used in metal machining operations may be related to a rare, irreversible lung disease, according to research presented at the European Respiratory Society's (ERS) International Congress today (28 September, 2015).

28 Sep 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration approved the new drug application for Tresiba (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba provides a long duration of action beyond 42 hours.

From Novo Nordisk 26 Sep 2015

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

25 Sep 2015

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.

16 Sep 2015

Allergan settles patent litigation with Amneal related to NAMENDA XR extended release capsules

Allergan plc, today announced that its subsidiaries Forest Laboratories, LLC and Forest Laboratories Holdings, Ltd., along with Adamas Pharmaceuticals, Inc., have entered into a settlement agreement with Amneal Pharmaceuticals LLC and related companies and subsidiaries.

10 Sep 2015

Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO (oxycodone HCI, USP) tablets -CII in the United States.

9 Sep 2015

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