Industry news

• Pfizer’s Rare Disease Drug to Be Approved Soon

  18 January 2019 GMP News

  Pfizer is finally closing on approval of its rare disease therapy tafamidis in the US, several years after it first reached the market in Europe. The FDA has accepted two separate marketing applications for the drug – both for cardiomyopathy associated with the rare disease ATTR amyloidosis – and awarded a priority review for one of them. Pfizer has said it thinks tafamidis has the potential to become a blockbuster.

• Environmentally-Friendly Methods in Pharma Industry

  18 January 2019 GMP News

  Researchers have developed a method using environmentally-friendly water and stable bonding between carbon and manganese instead of highly reactive metals. Drug production is a hugely cost-intensive process that can generate large amounts of waste product. Researchers at the University of Göttingen have now succeeded in developing a resource-saving “green” alternative.

• As Brexit nears, EMA improves staff retention forecast, commits to uninterrupted drug evaluations

  17 January 2019 Nick Paul Taylor / FierceBiotech

  The European Medicines Agency has increased its forecast of the proportion of staff that will relocate with it to Amsterdam. Buoyed by the improved outlook, the agency has predicted its core drug evaluation activities will be unaffected by the Brexit-enforced move.

• FDA planning new guidance, hires in cell and gene therapies for 2019

  17 January 2019 Conor Hale / FierceBiotech

  The FDA plans to hire at least 50 new clinical reviewers tasked with assessing cell and gene therapies to prepare for what the agency describes as a surge of cutting-edge products currently entering early development.

• FDA’s Plans for Digital Therapeutics

  16 January 2019 GMP News

  Pear Therapeutics in 2017 became the first company to get a “digital therapeutic” approved by the FDA, for patients trying to fight addiction to opioid drugs. The regulator is hoping to encourage further development of digital therapies and apps by using a framework based around pre-certification. This allows for fast development of apps from manufacturers whose software has been reviewed and approved by the FDA.

• 84 Positive Opinions from EMA in 2018

  15 January 2019 GMP News

  EMA has published an overview of its  recommendations of 2018 on the authorisation and safety monitoring of medicines for human use. New medicines are essential for public health as they can improve the treatment of diseases. In 2018, EMA recommended 84 medicines for marketing authorisation. Of these, 42 had a new active substance which has never been authorised in the EU before. 

• Collaboration of Japanese Companies in AI Drug R&D

  15 January 2019 GMP News

  Artificial intelligence and machine learning company InveniAI has joined with Kyowa Hakko Kirin to harness the power of technology for drug discovery. The companies are the latest to use AI and machine learning to make the drug development process more effective. In this case Kyowa Hakko Kirin will use InveniAi’s technology, dubbed AlphaMeld, to find new uses for drugs already in the pipeline at the Japanese pharma. 

• Russia Signed Implementation Drug Labeling System Document

  14 January 2019 GMP News

  Dmitry Medvedev, The Chairman of the Government of the Russian Federation on 14 December 2018 signed the Orders about implementation in the territory of the Russian Federation the system of monitoring drugs movement with the use of means of identification.

• Rewiring R&D: The FierceBiotech JPM 2019 breakfast debate

  14 January 2019 Ben Adams / FiercePharma

  We certainly like to offer a full breakfast here at FierceBiotech, especially at the J.P Morgan Healthcare Conference, where attendees have probably had to take out a second mortgage for a three-day hotel stay. So, we packed in as much as we could over a few hours early on Tuesday morning, the second day of JPM 2019, with a panel discussing what we see as the one of the biggest and potentially most complex issues for 2019: "Rewiring R&D: The Promises of Digital, AI, & Machine Learning for Biotech Research."

• At the end of a bumper year for approvals, FDA hit by government shutdown

  11 January 2019 Ben Adams / FiercePharma

  We saw a major milestone in FDA approvals in 2018, but a political deadlock that led to a partial government shutdown before Christmas could take some of the shine off a golden year.