07 February 2018
Russian pharmaceutical company NovaMedica (investment project of Rusnano) announces start of its cooperation in the area of transfer of knowledge and technologies between the R&D Center of NovaMedica Innotech and the German company Evonik – one of the leading companies in the international market of excipients manufacturing for the pharmaceutical industry. This partnership will result into creation of a training facility for transfer of competences in the area of pharmaceutical technologies at the premises of NovaMedica Innotech in Russia.
26 December 2017
Russian pharmaceutical company NovaMedica, investment project of Rusnano, informed about receipt of conclusion of the Ministry of Industry and Trade of the Russian Federation over compliance of the facility of the R&D Center of NovaMedica Innotech (subsidiary of NovaMedica) with the Russian standards of the Good Manufacturing Practice (GMP). The certificate issued basing on the integrated audit of the MIT RF commission, proves that the processes of development, manufacturing and quality control at NovaMedica Innotech are organized in accordance with the high standards of quality and manufacturing of tablets, soft and hard gelatin capsules and pellets at its manufacturing facilities meet the Russian GMP requirements.
22 December 2017
Russian pharmaceutical company NovaMedica (investment project of Rusnano) informed that it received approval of the Interdepartmental Committee (IDC) to conclude the Special Investment Contract (SPIC) within the investment project devoted to creation of a pharmaceutical plant for manufacturing of sterile injectable drug products in the Kaluga region. This is the first SPIC in the industry which is aimed at support of creation of a greenfield pharmaceutical facility.
23 October 2018
Genomic Health, Inc. (Nasdaq: GHDX) today announced results from multiple studies of its Oncotype DX® tests highlighting their value in optimizing treatment for patients with various stages of breast and prostate cancer. The findings, presented at the ESMO 2018 Congress in Munich, Germany, demonstrated that the Oncotype DX tests identify patients who will or will not benefit from a specific treatment.
23 October 2018
Siberian scientists have brought to the final stage of preclinical testing the only Russian therapeutic cancer drug. This part of the study is expected to be completed by the end of 2019, according to Sergei Netesov, Chairman of the Board of the Association for the Development of the Innovative Territorial Cluster of the Novosibirsk Region in the Sphere of Biopharmaceutical Technologies (‘Biopharm’).
22 October 2018
Pfizer has long been a player in kidney cancer, but it’s looking to take things up a notch—and challenge next-gen rival Bristol-Myers Squibb—with its latest data. Sunday at the European Society for Medical Oncology annual meeting, the New York drugmaker and partner Merck KGaA said their immuno-oncology agent Bavencio, in tandem with Pfizer’s Inlyta, had staved off cancer progression in previously untreated patients by a median 13.8 months, compared with 8.4 months for standard-of-care Sutent, another Pfizer drug.
19 October 2018
FDA published draft guidance on October 15, 2018 to assist sponsors developing treatments for rare diseases plan for pre-investigational new drug application (pre-IND) meetings with FDA. In the guidance, the agency describes topics that should be considered in early drug development and pre-IND meetings.