Industry news

• Specialty Pharma’s Move to Mainstream

  21 September 2018 Michelle Maskaly / Pharmaceutical Executive

  While definitions and classifications of what constitutes a specialty drug vary—and pricing and reimbursement factors remain thorny—there is little argument that this once-niche treatment market may be poised to steer the future of prescription medicine and patient care.

• Russia and South Korea will jointly develop biotechnology R&D

  21 September 2018 GMP News

  The Russian Direct Investment Fund (RDIF), the sovereign fund of the Russian Federation, JSFC Sistema, Russian publicly traded diversified holding company, the Medsi Group of Companies, a part of JSFC Sistema, have agreed with the South Korean company Green Cross Cell to develop jointly biotechnology in Russian Federation.

• Specialty Product Launch Insights

  20 September 2018 Lisa Henderson / Pharmaceutical Executive

  At the Veeva Systems Commercial Summit, held in May in Philadelphia, Veeva President Matt Wallach interviewed two biopharma CEOs on stage about their strategies for recent first-in-class approvals. Dr. Bill Carson, president and CEO of Otsuka Pharmaceutical Development & Commercialization Inc., took his turn with Abilify MyCite, the first FDA-approved digital medicine. Jeff Marrazzo, CEO and co-founder of Spark Therapeutics, discussed Luxturna, the first-ever gene therapy cleared by the FDA

• Russia prepares legislation changes to combat ‘ever greening’ patents

  20 September 2018 GMP News

  The Russian Federal Service for Intellectual Property (Rospatent) published a document on amendments to the Rules for drawing up, filing and reviewing documents that are the basis for committing legally significant actions for the state registration of inventions and their forms and Requirements to the documents for an application for grant of a patent for an invention approved by Order of the Ministry of Economic Development of the Russian Federation of 25 May 2016 No. 316.

• Patient groups rebuke CVS on ICER, saying cost-effectiveness reviews discriminate

  19 September 2018 Eric Sagonowsky / FiercePharma

  CVS last month made waves in pharma with a plan to allow clients to exclude drugs based on guidance from drug cost watchdog ICER. Now, patient advocacy groups are hitting back at the decision, urging CVS to reconsider and saying the cost-effectiveness calculations at ICER discriminate against the chronically ill, the elderly and others.

• Beyond Big Data: Meeting the Specialty Marketing Challenge

  19 September 2018 Julian Upton / Pharmaceutical Executive

  As we advance to an age where almost every new drug entering the market will be a specialty drug, the word “specialty” itself may eventually become redundant. The theory and practice of pharmaceutical marketing, however, is being strongly guided and shaped by the tactical and technological advancements brought about by the challenges of communicating and commercializing specialty treatments. 

• SID&GP presented results of manufacturers survey

  18 September 2018 GMP News

  On September 10 at the BIOTECHMED-2018 forum, Vladislav Shestakov – Director of the State Institute of Drugs and Good Practices – took part in the meeting dedicated to labeling of pharmaceutical products where he discussed prospects of pharmaceutical labeling and presented results of a survey of drug manufacturers’ preparedness for implementation of the labeling system.

• Russia approves new state strategy for pharmaceutical industry

  18 September 2018 Remedium

  A new state strategy for the development of the domestic pharmaceutical industry, known as "Strategy for the development of the pharmaceutical industry of Russia until 2030," has been recently approved by the Russian Ministry of Industry and Trade, with the aim to bring the Russian pharmaceutical production to a new level.

• GlobalData published new report on the Top 25 pharma companies

  17 September 2018 GMP News

  The performance highlights of the Top 25 publicly traded global pharmaceutical companies by Market Cap (Mcap) for the quarter ended June 30, 2018 (Q2), compared to the quarter ended March 31, 2018 (Q1), have been analyzed in the latest research from GlobalData, a leading data and analytics company.

• The Ministry of Health of the Russian Federation improves patent protection law

  17 September 2018 GMP News

  The Ministry of Health of Russia has published a notification on the development of amendments to Federal Law No. 61 of 12.04.2010 “On circulation of medicinal products”, designed to synchronize it with regulatory acts of the Eurasian Economic Union. The procedure for registration of the medicinal product will be corrected.