Industry news

• EMA Predicts Pharmacovigilance Contours in 2030

  13 December 2019 GMP News

  Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030. These predictions are made in an article from Guido Rasi, EMA’s Executive Director, Sabine Straus, the chair of EMA’s safety committee (PRAC) and Peter Arlett, the Agency’s Head of Pharmacovigilance and Epidemiology, published in Clinical Pharmacology and Therapeutics.

• Targeting a cell-death regulator to treat autoimmune diseases

  13 December 2019 Angus Liu / FiercePharma

  A research team led by scientists at the Walter and Eliza Hall Institute of Medical Research in Australia and the National Institute of Health’s (NIH's) National Human Genome Research Institute identified three families whose members suffered from similar autoimmune symptoms and discovered that they all had irregularities in RIPK1, a gene that makes a key protein in the mediation of cell death and inflammation. By examining the patients’ exomes, which are the protein-encoding regions of the genome, the team found the seven patients showed different mutations but at the exact same location of RIPK1, according to one of the Nature studies.

• Can you hear me, pharma? Voice-enabled apps are on the rise—and please don't freak out about privacy

  12 December 2019 Beth Snyder Bulik / FiercePharma

  The potential for voice-enabled apps in pharma is just beginning to be realized. Think drug adherence and symptom tracking, or injection tutorials and direct reports to healthcare providers.

• Results of EMA CVMP 3-5 December 2019 Meeting

  11 December 2019 GMP News

  The Committee adopted by consensus a positive opinion for a grouped type II variation application for Onsior to add a new therapeutic indication for the treatment of pain and inflammation associated with soft tissue surgery in dogs and to amend the product information due to new clinical data.

• 8 programs to watch in NASH: Four letters and a multibillion-dollar opportunity

  11 December 2019 Amirah Al Idrus / FiercePharma

  From Big Pharmas like Novartis and Gilead to liver specialists and one-asset biotechs, it seems like everyone in biopharma has some skin in the NASH game. It makes sense, said Tarek Hassanein, M.D., a professor of medicine and director of outreach services for liver transplantation at the University of California San Diego School of Medicine. With the rise of obesity not just in the U.S. but all over the world, the number of people with NASH (nonalcoholic steatohepatitis) will only grow. 

• What’s New in Manufacturing: Upstream Technologies

  10 December 2019 Lauren Lavelle / BioPharm International

  Various pieces of equipment to advance upstream bioprocess have been introduced within recent months. The following products showcase a select few of those advancements

• US Maintains Lead in Pharma Innovation

  10 December 2019 BioPharm International

  A recent survey of pharma industry experts revealed the US pharmaceutical industry continues to lead global peers in innovation and competitiveness; however, the United States trails China, India, and Germany in overall market growth potential. The survey, CPhI Pharma Industry Rankings, which polled 350 top pharma experts on the strength of major pharmaceutical markets and global performance in 2019, was released in November 2019.

• US Senate Committee Advanced Nomination of Stephen Hahn to Lead FDA

  09 December 2019 GMP News

  Dr. Hahn, a chief medical executive at the University of Texas M.D. Anderson Cancer Center, was nominated by President Trump last month to replace Dr. Scott Gottlieb, who left the job in April.

• FDA Finalized Guidance on Adaptive Clinical Trial Designs for Drugs and Biologics

  09 December 2019 GMP News

  The 33-page guidance, which finalizes a draft version released for comment in September 2018 and replaces an earlier guidance from 2010, sets out FDA’s recommendations on adaptive trial design principles and the information FDA will review from adaptive studies submitted as part of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and supplemental applications.

• Investment and Skills Demand in UK Cell and Gene Therapy Industry Rising, According to Data

  06 December 2019 BioPharm International

  Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.