Industry news

• The top AI lighthouse projects to watch in biopharma

  22 October 2019 Conor Hale / FierceBiotech

  So-called lighthouse projects are typically defined as small efforts focused on deliverables in a narrow area, designed to establish a pathway for larger enterprises down the line. But as the biopharma industry’s digital transformation continues apace, with the rapid acceptance of tools such as artificial intelligence and machine learning, certain projects promise to yield impacts on a much wider scale.

• Driving Improved Access to Biosimilars

  22 October 2019 Agnes Shanley / BioPharm International

  As public opinion of the pharmaceutical and biopharmaceutical industry continues to worsen in Gallup polls (1) in the United States, drug prices remain a hot button political issue. This is particularly true for insulin. In a formal statement in December 2018 (2), former FDA commissioner Scott Gottlieb referred to insulin prices, which have increased nearly 600% between 2001 and 2015, with the average US list price rising by 15% per year between 2012 and 2016. He suggested that biosimilar versions of insulin would be likely to reach the market over the next few years.

• Representatives of Russian and Belarus Pharma Inspectorates Met in Minsk

  21 October 2019 GMP News

  The working meeting between pharmaceutical inspectorates’ representatives of Russia and Republic of Belarus took place in Minsk city last week, initiated by the Ministry of Health of the Republic of Belarus, in terms of which representatives of authorized entities of the two EAEU member countries exchanged opinions about organizational structures and current quality systems of medicines.

• EMA Recommended Seven New Medicines for Approval

  21 October 2019 GMP News

  The Committee recommended granting conditional marketing authorisation for Ervebo (Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. “This is an important step towards relieving the burden of this deadly disease. The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola,” said Guido Rasi, EMA’s Executive Director.

• European Countries Continue to Reduce Use of Antibiotics in Animals

  17 October 2019 GMP News

  A report published by EMA shows that European countries continue to reduce the use of antibiotics in animals. The overall sales of veterinary antibiotics across Europe dropped by more than 32% between 2011 and 2017.

• EMA Requests Risk Evaluation for Drugs Containing Chemically Synthesised APIs

  17 October 2019 GMP News

  EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)”. This document addresses all marketing authorisations holders for drugs containing chemically synthesised active substances in the EU. It requests that all marketing authorisation holders, who are ultimately responsible for the quality, safety and efficacy of a medicinal product, conduct a risk evaluation regarding potential nitrosamine contamination.

• Want to win over investors with your M&A deals, pharma? Here's how: analyst

  16 October 2019 Angus Liu / FiercePharma

  Biopharma deals have really taken off recently, featuring such megamergers as those between Takeda and Shire, Bristol-Myers Squibb and Celgene, and AbbVie and Allergan. But these humongous transactions aren’t necessarily healthy for short-term shareholder returns, one group of analysts has found.

• Regulatory Process Innovation & The Dangers of Over-Promising with AI

  15 October 2019 Alan White / Pharmaceutical Exacutive

  Never previously at the forefront of technology innovation, the life sciences industry now accepts that it needs to transform its agility, responsiveness and cost-efficiency, and that advanced digital tools are likely to form an important part of that strategy. Yet more modest-sized pharma companies and smaller biotech firms, who need an edge every bit as much as their larger peers, need to take a guarded approach to overhyped, generic AI solutions and vendors and service providers who promise the earth as a result of their use of the latest technology. AI has huge potential, certainly, but the key to ROI is in the application. 

• Developing new antibiotics – essential research should not be a question of money

  14 October 2019 Johannes Suciu / European Pharmaceutical Review

  Every year about 700,000 people worldwide die as a direct consequence of an infection due to multi-resistant pathogens. Even in Europe where medical standards are high, the death toll has risen from 25,000 to 33,000 over the last decade. The healing capability is likely to continue to deteriorate and antibiotic resistance will become an increasing threat.

• Global Pharmaceutical Excipients Market Projected to Reach $9.79bn by 2025

  13 October 2019 GMP News

  The “Pharmaceutical Excipients Market by Product (Organic Chemicals, Inorganic chemicals), Functionality (Fillers, Diluents, Coatings, Disintegrants), Formulation (Tablet, Capsule, Topical, Parenteral) – Global Forecast to 2025” report analyzes the pharmaceutical excipients market and aims at estimating the market size and future growth potential of this market based on various segments such as product, formulation, functionality, and region. The report also provides a competitive analysis of the key players in this market, along with their company profiles, product offerings, recent developments, and key market strategies.