Industry news

• FDA Modernizes Inspection of Sterile Products

  16 November 2018 BioPharm International

  FDA announced on Nov. 9,  2018  that it has developed a New Inspection Protocol Project (NIPP) to modernize the collection of data from surveillance and preapproval inspections of sterile drugs. FDA is applying NIPP, which uses standardized electronic inspection protocols, to its inspections of sterile injectable drugs. The agency hopes NIPP will “ensure a more streamlined and consistent coverage and reporting of our inspectional activities,” according to FDA Commissioner Scott Gottlieb, MD. Full implementation of the new protocols is expected within the next two years.

• Marketing Seniors want drug prices in ads. Young people? Eh, whatever: survey

  16 November 2018 Beth Snyder Bulik / FiercePharma

  Who wants drug prices in ads? Older people, that’s who. A recent survey by Wells Fargo Securities found that 77% of people 65 and older think pharma companies should be required to disclose prices in ads. That compares with just 40% of people 18 to 24 who think the price should be included.

• 13,000 drugs have already passed through the tracking system in Russia

  15 November 2018 GMP News

  On November 1, 2018, the functions of the operator of the information system for monitoring the movement of drugs (IS MDLP) were transferred from the Federal Tax Service of Russia to the Center for the Development of Advanced Technologies (CDAT). The IS MDLP became part of the Unified National System for Goods Labeling and Tracking. Its website contains new section with relevant information and support service.

• Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

  15 November 2018 BioPharm International

  On Nov. 6, 2018, Rentschler Biopharma, a Laupheim, Germany-based contract development and manufacturing organization, and LEUKOCARE, a Munich, Germany-based provider of biopharmaceutical formulation platforms, reported results from their joint survey, “Formulation in the Drug Product Development Process,” based on research from Informa Pharma Intelligence. 

• New Life Science Park to be created in St Petersburg

  14 November 2018 GMP News

  St. Petersburg Technopark will receive a grant under the cooperation program “South-Eastern Finland – Russia 2014 – 2020” for the implementation of the Life Science Park project. According to the head of the Regional Engineering Centre for microreactor synthesis of active pharmaceutical ingredients (REC API), Elena Petrova, the University of Kotka will be a participant from the Finnish side.

• Russian scientists started trials for new ankylosing spondylitis drug

  14 November 2018 GMP News

  According to Alexey Sitalo, president of the Society for Mutual Assistance in Ankylosing Spondylitis, scientists of the N.I. Pirogov Russian National Research Medical University (RNRMU) began trials of the world’s first drug without any side effects for the treatment of an incurable joint disease (Bekhterev’s disease), which affects up to half a million people in the Russian Federation.

• Japanese pharma industry energized by the next wave of growth

  13 November 2018 GMP News

  Japan’s pharmaceutical industry is the third largest worldwide after the US and China with a share of approximately ten percent of the world market and a value expected to reach $109 billion by 2026. Both the Japanese market and industry however, have proved difficult for international companies to access due to a complex regulatory system and pricing process – yet this is set to change.

• Machine learning for pharma marketers: The time is now to budget, experiment and adjust, expert says

  13 November 2018 Beth Snyder Bulik / FiercePharma

  When does CMI/Compas executive Paul Kallukaran think pharma companies should start looking at using machine learning in their marketing strategies? "Yesterday," he said at a recent digital conference. The good news, however, is that it’s not too late.

• US scientists reports of promising studies on peptide-based cancer vaccine

  12 November 2018 GMP News

  A team of researchers from the Dr. Rath Research Institute (USA) has developed a cancer vaccine effective in reducing tumor growth. The study was published in the online Journal of Cellular Medicine and Natural Health. The peptide-based vaccine targets specific enzymes called metalloproteinases (MMPs) that are necessary for any cancer to grow tumors, metastasize, and form blood vessels in tumors (angiogenesis).

• Emerging UK collaboration will help to promote biomedical research

  12 November 2018 GMP News

  Medicines Discovery Catapult and the Medical Research Council (MRC) Centre for Drug Safety Science (CDSS) have agreed a memorandum of understanding to combine their academic and industry expertise developing next generation 3D human cell models and creating robust cellular platforms.