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Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Tioga Pharmaceuticals announces commencement of asimadoline Phase 2 study for treatment of pruritus

Tioga Pharmaceuticals announces commencement of asimadoline Phase 2 study for treatment of pruritus

Tioga Pharmaceuticals, a clinical stage biotechnology company, today announced the initiation of a Phase 2 clinical study of asimadoline, a novel, well-studied kappa-opioid receptor specific agonist, for the treatment of pruritus or itching. The double-blind, placebo-controlled clinical study is designed to evaluate the safety, tolerability, and clinical efficacy of asimadoline in patients with pruritus due to atopic dermatitis and is being conducted at 20 clinical study centers in the United States. [More]
LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. [More]
FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent (alirocumab) Injection. [More]
Merck Canada announces conditional approval of KEYTRUDA (pembrolizumab) for melanoma treatment

Merck Canada announces conditional approval of KEYTRUDA (pembrolizumab) for melanoma treatment

Merck Canada Inc. announced today that KEYTRUDATM (pembrolizumab) was authorized for sale with conditions by Health Canada on May 19, 2015. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to fight advanced melanoma, the most serious form of skin cancer. It is the first of a new class of therapies called anti-PD-1s approved in Canada. [More]
Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted for filing and review its Biologics License Application for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Amgen and Merck expand collaboration for Talimogene laherparepvec-KEYTRUDA combination study

Amgen and Merck expand collaboration for Talimogene laherparepvec-KEYTRUDA combination study

Amgen and Merck, known as MSD outside the U.S. and Canada, today announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 1, open-label trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). [More]
Pembrolizumab (Keytruda) effective in patients with recurrent or metastatic head and neck cancer

Pembrolizumab (Keytruda) effective in patients with recurrent or metastatic head and neck cancer

Immunotherapy with the anti-PD-1 antibody pembrolizumab (Keytruda) was effective in one out of four patients with recurrent or metastatic head and neck cancer, according to results presented at the 2015 meeting of the American Society for Clinical Oncology. [More]
FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

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. [More]
Monoclonal antibody nivolumab improves survival rates of melanoma patients

Monoclonal antibody nivolumab improves survival rates of melanoma patients

The monoclonal antibody nivolumab has shown promise as a therapeutic agent, particularly by improving the survival rates of melanoma patients. Jeffrey S. Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center will be presenting data from a retrospective analysis of the safety of nivolumab in 4 ongoing phase I-III studies in melanoma patients at the 2015 American Society of Clinical Oncology Annual Meeting in Chicago. [More]
Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

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. [More]
Phase 2 IMAGO trial of SHP625 fails to meet primary endpoints in pediatric patients with ALGS

Phase 2 IMAGO trial of SHP625 fails to meet primary endpoints in pediatric patients with ALGS

Shire plc today announced that the 13-week Phase 2 IMAGO trial of its investigational compound SHP625 (LUM001) did not meet the primary or secondary endpoints in the study of 20 pediatric patients with Alagille syndrome (ALGS), a rare, life-threatening genetic disorder that presents with chronic cholestasis (accumulation of bile acids in the liver) and severe pruritus (itching). [More]
New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26. [More]
Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). [More]
Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII. [More]
Egalet announces net revenues of $1.9 million for 2014

Egalet announces net revenues of $1.9 million for 2014

Egalet Corporation today reported financial results for the year ended December 31, 2014. [More]
Results of pacritinib Phase 2 study in myelofibrosis patients published in journal 'Blood'

Results of pacritinib Phase 2 study in myelofibrosis patients published in journal 'Blood'

CTI BioPharma Corp. today announced that results of a Phase 2 study of pacritinib, in patients with myelofibrosis were published in the journal Blood. Pacritinib is a next-generation oral JAK2/FLT3 multikinase inhibitor currently in Phase 3 development in the PERSIST program. [More]
Good news for patients suffering from shingles

Good news for patients suffering from shingles

The Journal of Drugs in Dermatology is delighted to present new findings from the Mayo Clinic's Department of Dermatology showing possible relief from the complications and pain secondary to Herpes Zoster, commonly known as shingles. [More]

Cipher acquires worldwide rights to three products from Astion

Cipher Pharmaceuticals Inc. today announced it has strengthened its product pipeline by acquiring the worldwide rights to three products from Astion Pharma, a Denmark-based specialty pharmaceutical company. [More]
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