Hypersensitivity News and Research

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

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

29 May 2015

New clinical data demonstrating treatment options in Lilly's diabetes portfolio to be presented at ADA Scientific Sessions

New clinical data demonstrating the range of treatment options represented in Lilly's diabetes portfolio will be presented in 79 abstracts on June 5-9, at the 75th American Diabetes Association (ADA)® Scientific Sessions in Boston.

29 May 2015

Lilly Diabetes Alliance, Boehringer Ingelheim to present study results at ADA’s Scientific Sessions

The presentation of 35 abstracts will demonstrate the breadth and depth of the Boehringer Ingelheim and Eli Lilly and Company Diabetes alliance portfolio at the 75th American Diabetes Association's (ADA) Scientific Sessions® in Boston, June 5-9.

29 May 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015.

28 May 2015

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration for Xifaxan 550 mg for the treatment of IBS-D in adults.

28 May 2015

Canadian researchers shed light on molecular dynamics of chronic pain

Chronic pain affects hundreds of millions of people worldwide and is a major cause of disability, causing more disability than cancer and heart disease. Canadian researchers, including Michael Salter at SickKids are shedding light on the molecular dynamics of chronic pain. They have uncovered a critical role for a class of cells present in the brain and spinal cord, called microglia, in pain.

27 May 2015

Researchers make important breakthrough in identifying major drivers of excessive coughing

Cough treatments could change dramatically after the herpes virus helped researchers discover that the respiratory tract links to two different parts of the nervous system.

27 May 2015

Scientists uncover role of HTRA3 protease in Cockayne syndrome

Scientists from the Institut Pasteur and CNRS, in collaboration with scientists from the Institut Gustave Roussy and CEA, have succeeded in restoring normal activity in cells isolated from patients with the premature aging disease Cockayne syndrome. They have uncovered the role played in these cells by an enzyme, the HTRA3 protease.

22 May 2015

UCB sponsoring several presentations on Cimzia for Crohn's disease at DDW 2015

UCB, a global biopharmaceutical company focusing on immunology and neurology treatment and research, is sponsoring several data presentations on Cimzia (certolizumab pegol) at Digestive Disease Week 2015, taking place in Washington, DC from May 16-19.

17 May 2015

Orexigen Therapeutics provides update on business and financial results for Q1 2015

Orexigen Therapeutics, Inc. today announced business and financial results for the first quarter ended March 31, 2015.

8 May 2015

STA, Helsinn announce approval of AKYNZEO for prevention of chemotherapy-induced CINV

Australian biopharmaceutical company Specialised Therapeutics Australia and Helsinn, a Swiss group focused on building quality cancer care, announce that the Therapeutic Goods Administration has approved AKYNZEO for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

8 May 2015

ViiV Healthcare initiates Phase III trial to evaluate dolutegravir and rilpivirine in HIV patients

ViiV Healthcare today announced the start of a Phase III clinical trial programme to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV.

6 May 2015

Special issue of Gastroenterology highlights how food impacts health and disease

Patients are always interested in understanding what they should eat and how it will impact their health. Physicians are just as interested in advancing their understanding of the major health effects of foods and food-related diseases.

28 Apr 2015

AbbVie's all-oral, interferon-free therapy granted FDA priority review for treatment of GT4 HCV infection

AbbVie has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).

25 Apr 2015

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A.

From Baxter International Inc. 16 Apr 2015

Nielsen BioSciences launches skin test that helps physicians manage Valley Fever infections

Nielsen BioSciences announced today the launch of SPHERUSOL (Coccidioides immitis Spherule-Derived Skin Test Antigen), a skin test that provides valuable data to physicians managing Valley Fever infections. SPHERUSOL has been approved by the U.S. Food and Drug Administration as the only skin test to detect an immune response to the fungus called Coccidioides, or "cocci," in patients with history of the disease.

9 Apr 2015

Combined therapy boosts growth in short children with low IGF-1

Children with short stature benefit from receiving combined treatment with growth hormone and insulin-like growth factor-1, if they have low endogenous levels of the latter, a study shows.

1 Apr 2015

Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck, known as MSD outside the United States and Canada, announced today that GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck's 9-valent human papillomavirus (HPV) vaccine, is now available in Canada.

1 Apr 2015

MOVANTIK (naloxegol) now available in U.S. for treatment of OIC in adult patients with non-cancer pain

Nektar Therapeutics reported that partner AstraZeneca announced today that MOVANTIK (naloxegol) has launched in the United States. On September 16, 2014, the US Food and Drug Administration (FDA) approved MOVANTIK as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.

31 Mar 2015

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy.

30 Mar 2015

Hypersensitivity News and Research

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

New clinical data demonstrating treatment options in Lilly's diabetes portfolio to be presented at ADA Scientific Sessions

Lilly Diabetes Alliance, Boehringer Ingelheim to present study results at ADA’s Scientific Sessions

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Canadian researchers shed light on molecular dynamics of chronic pain

Researchers make important breakthrough in identifying major drivers of excessive coughing

Scientists uncover role of HTRA3 protease in Cockayne syndrome

UCB sponsoring several presentations on Cimzia for Crohn's disease at DDW 2015

Orexigen Therapeutics provides update on business and financial results for Q1 2015

STA, Helsinn announce approval of AKYNZEO for prevention of chemotherapy-induced CINV

ViiV Healthcare initiates Phase III trial to evaluate dolutegravir and rilpivirine in HIV patients

Special issue of Gastroenterology highlights how food impacts health and disease

AbbVie's all-oral, interferon-free therapy granted FDA priority review for treatment of GT4 HCV infection

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nielsen BioSciences launches skin test that helps physicians manage Valley Fever infections

Combined therapy boosts growth in short children with low IGF-1

Merck announces availability of GARDASIL 9 HPV vaccine in Canada

MOVANTIK (naloxegol) now available in U.S. for treatment of OIC in adult patients with non-cancer pain

Hospira announces availability of INFLECTRA (infliximab) in Canada

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