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FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

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). [More]
Risk of hepatobiliary cancer higher in women with intrahepatic cholestasis of pregnancy

Risk of hepatobiliary cancer higher in women with intrahepatic cholestasis of pregnancy

In a new study of more than 125,000 pregnant women in Sweden, researchers at the Sahlgrenska Academy found that the risk of hepatobiliary cancer and immune-mediated and cardiovascular diseases later in life is higher in women with intrahepatic cholestasis of pregnancy (ICP) than in women without this condition. [More]
Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher Pharmaceuticals Inc. today announced that it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin to the U.S. Food & Drug Administration. [More]
Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis today announced the US Food and Drug Administration has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. [More]
EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. [More]
Acupuncture can be more effective in treatment of dermatologic conditions

Acupuncture can be more effective in treatment of dermatologic conditions

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, "placebo acupuncture," or no treatment, according to a review of the medical literature published in the Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. [More]
Risk of hepatobiliary cancer, cardiovascular diseases later in life is higher in women with ICP

Risk of hepatobiliary cancer, cardiovascular diseases later in life is higher in women with ICP

In a new study of more than 125,000 pregnant women in Sweden, researchers found that the risk of hepatobiliary cancer and immune-mediated and cardiovascular diseases later in life is higher in women with intrahepatic cholestasis of pregnancy (ICP) than in women without this condition. [More]
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]
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