Pharma News

AVEO Oncology announced that the European Commission (EC) has approved FOTIVDA® (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.i EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

Boehringer Ingelheim and pharmaceutical company Pharmaxis announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1, and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

Zealand Pharma A/S ("Zealand") reports that Boehringer Ingelheim has announced the initiation of two Phase 1 trials, the first with a glucagon/GLP-1 agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes and the second with a novel differentiated long-acting amylin analog for the treatment of obesity and/or diabetes.

Zydus Cadila has received the final approval from the USFDA to market Candesartan Cilexetil Tablets USP and Ziprasidone Hydrochloride Capsules

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors. Nearly one in three people with hemophilia A develop inhibitors to standard factor VIII replacement therapies, which limits treatment options and increases the risk of life-threatening bleeds and repeated bleeds, particularly in joints, that cause long-term damage.

Organovo Holdings, Inc announced it has awarded the 2017 ExVive 3D Tissue Application Award to researchers at Amgen, Inc and Medikine, Inc.  The program is designed to explore new applications using Organovo’s ExVive Liver and Kidney Tissues in collaboration with biopharmaceutical partners.  The Company had many applicants for its awards, with the winners submitting the two most creative and novel proposals with the aim of bridging preclinical and clinical research.  The projects will be performed by Organovo and include comprehensive studies and data analysis.

A first ever breakthrough in the area of osteoarthritis, a most common chronic condition of the joints that afflicts mainly the weight-bearing joints such as hips and knees, and causes physical disabilities. At present there is no viable treatment available for osteoarthritis. CDRI(Central Drug Research Institute) Scientists has developed a standardized nano-formulation from Spinaceaoleracea commonly known as Palak for treatment of osteoarthritis. And it is patented for formulation of Spinaceaoleracea for the prevention  and /or treatment of bone related disorders by CDRI

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Licorice roots have a diverse and flavorful history, having been used in ancient Egyptian times as a tea and in traditional Chinese medicines, all the way to a flavoring agent and as an ingredient in some licorice candies. Some women now take licorice extracts as supplements to treat hot flashes and other menopausal symptoms. But scientists caution that the substance could pose a health risk by interacting with medications.

The parasite Cystoisospora suis causes diarrhea in pigs, especially in newborn piglets, and is capable of quickly spreading across farms. For this reason, pig farmers in Europe preventively use toltrazuril to control parasite development. In contrast to congeneric parasites in chicken, no resistance to this pharmaceutical compound was described in pig parasites until recently. In an article in Parasites & Vectors, researchers of the University of Veterinary Medicine, Vienna, have now for the first time confirmed that toltrazuril is ineffective against a Dutch isolate of the parasite. Even though antiparasitic resistance in pig parasites is developing slowly, monitoring of resistance should be intensified due to the lack of alternative treatment options, and increased hygiene measures should be taken to prevent pathogen spread.When newborn piglets suffer from diarrhea, this is frequently caused by the intestinal parasite Cystoisospora suis.

The settlement resolves claims relating to the classification of EpiPen® Auto-Injector and EpiPen Jr® Auto-Injector for purposes of the Medicaid Drug Rebate Program. The question in the underlying matter was whether the EpiPen products were properly classified with the Centers for Medicare and Medicaid Services ("CMS") as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.