Industry news

• Education and strategy are key to nurturing biosimilars for success

  15 January 2020 FiercePharma

  Heralded as the next great chapter in pharmaceutical history, biosimilars are expected to trim healthcare costs while giving patients more access at lower prices. Adopted with open arms in the European market, the move to biosimilars in the U.S. has been a slog.

• More control over the antibiotics in the Russian agricultural sector

  14 January 2020 GMP News

  “Federal Service for Veterinary and Phytosanitary Surveillance (FSVPS) has developed and sent to the Ministry of Agriculture a package of amendments to the law ‘On Veterinary Medicine’, which regulates the use of antibiotics in livestock and poultry farming,” said Sergey Dankvert, the head of the department.

• Announced the launch of the Unified Website for Biotechnology Regulation

  14 January 2020 GMP News

  The U.S. Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

• Biotech With 45 new drug approvals in 2019, ‘friendly’ FDA is here to stay

  13 January 2020 Amirah Al Idrus / FiercePharma

  It looks like drug approvals have well and truly bounced back. 2019’s total of 45 approvals may not have hit the record high posted in 2018, but it fits into a general upward trend since 2016, when the FDA approved just 22 drugs.

• Mendeleev Valley Innovation Scientific and Technological Center is being created in Moscow

  10 January 2020 GMP News

  According to the documents signed by Russian Prime Minister Dmitry Medvedev on December 24, the Innovative Scientific and Technological Center Mendeleev Valley is being created, in order to implement the priorities of scientific and technological development of Russia and increase the investment attractiveness of research and development.

• Cancer immunotherapy market will reach $115 billion by 2023

  10 January 2020 GMP News

  Immunotherapy is forecast to become the oncology treatment of choice with an estimated 60 percent of previously treated cancer patients likely to adopt immunotherapy. This is according to explains that fast growth in this market is likely to be accelerated by multiple treatment lines, combination therapy and the opportunity for repeat treatment.

• Lots of cash and tasty targets signal deals to come—and it may be now or never: analyst

  09 January 2020 Angus Liu / FiercePharma

  Brace yourselves, pharma watchers. With the annual J.P. Morgan Healthcare Conference around the corner, some major biopharma deal announcements could hit the headlines, just as Bristol-Myers Squibb unveiled its $74 billion Celgene buyout and Eli Lilly its $8 billion Loxo Oncology takeover last year. 

• Pharma's gene and cell therapy ambitions will kick into high gear in 2020—despite some major hurdles

  09 January 2020 Arlene Weintraub / FiercePharma

  In January 2019, then-FDA commissioner Scott Gottlieb ushered in the new year with a bold prediction: The agency, he said, would be approving between 10 and 20 gene and cell therapies per year by 2025. At the time, there were a whopping 800 such therapies in the biopharma pipeline and the FDA was aiming to hire 50 new clinical reviewers to handle the development of the products.

• Investments in Pharmaceutical Industry. Focus on Moscow Region

  30 December 2019 GMP News

  The 2019 pharmaceutical sector indicators attest to an uptrend in the market. According to the analytical report by RNC Pharma, Russian pharmaceutical companies increased the volumes of drugs shipped over the first eight months this year. Output added 4.5% in physical terms and 20.2% – in money terms, reaching 2.83 billion packs and RUB 255 billion respectively. 

• Will we see the world's first approved NASH drug in 2020?

  24 December 2019 Nick Paul Taylor / FierceBiotech

  Nonalcoholic steatohepatitis (NASH) has been among the closely watched indications in biotech since January 2014, when Intercept Pharmaceuticals lit a fire under the field with midphase data that sent its share price up 500%. Now, Intercept is on the cusp of delivering on the promise that caused investors to pile into the stock.