Industry news

• OTC drugmakers face an uphill battle on Amazon. But they should still be there, expert says

  20 November 2018 Beth Snyder Bulik / FiercePharma

  Amazon is now the third-largest digital ad platform, but pharma marketers are mostly shut out. That’s because most of Amazon’s ads are for products sold by retailers, and of course, prescription drugs can't be purchased that way.

• New insight into why malaria drugs work against some cancers could boost drug development

  20 November 2018 Arlene Weintraub / FiercePharma

  There are currently about 20 clinical trials underway evaluating a class of malaria drugs known as chloroquines in several  tumor  types, including breast cancer, lung cancer and multiple solid  tumors , according to ClinicalTrials.gov. Anti-malarial drugs, in fact, have long been of interest in the oncology community because of their ability to shrink some cancers.

• New CRO-focused report indicates shift towards modernization of clinical trials

  19 November 2018 GMP News

  Contract research organizations (CROs) are driving industrywide momentum to unify clinical systems and streamline trial processes, according to a new global industry survey from Veeva Systems, a cloud-computing company focused on pharmaceutical and life sciences industry applications.

• EMA published new guidance on paediatric medications

  19 November 2018 GMP News

  The European Medicines Agency (EMA) has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.

• 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.