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Roche’s new tablet for fatal lung disease cleared in EU
June 28, 2017 Off

Roche’s new tablet for fatal lung disease cleared in EU

By Dino Mustafić

Roche’s new tablet for treating certain types of idiopathic pulmonary fibrosis (IPF) was approved by the European Commission, the Swiss drugmaker announced on Tuesday.

“Pharma bro’ Martin Skreli’s notoriety slows New York jury selection
June 28, 2017 Off

“Pharma bro’ Martin Skreli’s notoriety slows New York jury selection

By Dino Mustafić

Jury selection in the New York trial of former drug company executive Martin Shkreli will enter its third day Wednesday, after some potential jurors said they could not be fair to a man who gained notoriety by raising the price of a life-saving drug more than 5,000 percent.

Novartis’s Erelzi cleared in Europe
June 28, 2017 Off

Novartis’s Erelzi cleared in Europe

By Dino Mustafić

Novartis ahs won European clerance for Erelzi, as the European Commission approved it for Novartis’s division Sandoz.

Survey: importance of standardized label management in pharmaceutical industry
June 28, 2017 Off

Survey: importance of standardized label management in pharmaceutical industry

By Dino Mustafić

A recent survey on the state of label management in the pharmaceutical industry undertaken by NiceLabel in cooperation with Pharmaceutical Manufacturing reveals the challenges facing pharmaceutical manufacturers as they try to produce accurate, compliant labels, and highlights the increasing importance of a single, integrated label management system.

June 28, 2017 Off

Mitra, Fuji Pharma ink women’s health product deal in Japan

By Dino Mustafić

An exclusive License and Supply Agreement (LSA) has been signed between Fuji Pharma, the leader in women’s health in Japan, and Mithra, a Euronext -listed company specialized in women’s health, for the commercialization of Donesta in Japan and ASEAN territories.

The FDA grants approval of orphan drug Haegarda to Behring
June 23, 2017 Off

The FDA grants approval of orphan drug Haegarda to Behring

By Dino Mustafić

CSL Behring LLC, has gotten the FDA’s approval of Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

June 23, 2017 Off

LEADER trial data included in Novo Nordisks Saxenda in Europe

By Dino Mustafić

Novo Nordisk got the right from the European Medicines Agency’s committee (EMA) to include data from the LEADER trial to Saxenda to the results from the trial showed the long-term effects of Victoza for type 2 diabetes and established cardiovascular disease patients.

Novartis’s certain cancer combination approved by FDA; fourth actionable genomic biomaker in metastatic NSCLC
June 22, 2017 Off

Novartis’s certain cancer combination approved by FDA; fourth actionable genomic biomaker in metastatic NSCLC

By Dino Mustafić

Novartis was cleared on Thursday by the US Food and Drug Administration (FDA) for combination of Tafinlar (dabrafenib) with Mekinist (trametinib) for treating metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express the BRAF V600E mutation, which is fourth actionable genomic biomaker in metastatic NSCLC

Novartis’s large heart attack realted study meets endpoints
June 22, 2017 Off

Novartis’s large heart attack realted study meets endpoints

By Dino Mustafić

Novartis’s Phase III Cantos study of ACZ885 (canakinumab), one of the largest in the company’s history, combined with standard of care in people with a prior heart attack and inflammatory atherosclerosis has met the primary endpoint.

ValiRx forms advisory board
June 22, 2017 Off

ValiRx forms advisory board

By Dino Mustafić

ValiRx’s has formed an Advisory Board to support its main board in new strategic guidance and technical advice.

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