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13

Sanofi gets rights to Tamiflu in the US market

The French group Sanofi has signed an agreement with Roche on the transfer of rights to the antiviral drug Tamiflu (oseltamivir) in the United States. Sanofi will receive exclusive rights to Tamiflu over-the-counter in the United States.  This drug is intended for the prevention and treatment of influenza. Alan Main, executive vice president of consumer…

14

Trastuzumab and bevacizumab biosimilars enter the US market

For a long time, Roche’s three drugs, Rituxan, Herceptin and Avastin, dominated the global market. However, on July 18, their competitors appeared – Amgen and Allergan introduced the biosimilars of Herceptin preparations for the treatment of HER2-positive breast cancer and Avastin for the treatment of colorectal cancer to the USA, which threatened the total sales…

15

FDA Approved Bayer Gadavist Contrast Agent Contrast Agent

Bayer Gadavist (gadobutrol) is the first and only contrast agent for use in cardiac magnetic resonance imaging (CMRT) in adult patients with diagnosed or suspected coronary heart disease (CHD) and has been approved by the FDA. This decision is based on the data of two prospective multicenter open phase non-randomized blind clinical trials of the…

16

A historic mutual recognition agreement between FDA and EMA was signed

The FDA and EMA have confirmed the inclusion of Slovakia in the mutual recognition agreement. The activities of this country’s GMP inspectorate received a positive assessment. The authorities announced this on Friday, July 12, before the deadline (July 15), which was set aside for all parties to sign the contract. Now, the FDA has recognized…

17

R-Pharm will bring technology for the early diagnosis of lung cancer to the Russian market

The R-Pharm group of companies, together with the British developer Oncimmune Holdings, have signed an exclusive agreement to introduce the EarlyCDT Lung product for early detection of lung cancer to the Russian and Eurasian Customs Union countries. The development of Oncimmune is a specific blood test technology that facilitates the early detection of lung cancer…

18

GEROPHARM registered the first Russian insulin bioanalogue

GEROPHARM received a registration certificate for two-phase insulin lispro under the trade name RinLiz®. These are the first Russian bioanalogues of ultrashort and medium duration insulin in the GEROPHARM portfolio. The company plans to produce them on a full cycle basis – from substance to finished dosage form. Now on the Russian market insulin lispro…