Regulatory
MagForce AG, a leading medical device company in the field of nanomedicine focused on oncology, published today its financial results as of and for the year ended December 31, 2018 as well as operative highlights.
The U.S. Food and Drug Administration (FDA)’s Circulatory System Devices Panel is in the middle of two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). The discussions are noting missing data and conflicting analysis.
Trade tensions between Washington, D.C. and Beijing continue, but have not yet impacted the pharmaceutical products traded between the two countries. However, if the punitive tariffs continue and pharma is impacted, a third global player could step in to fill the void in both countries.
Transparency in clinical trials has been a concern and the new study highlights the continued issue.
In light of the Center for Disease Control and Prevention’s guidelines for safe cold chain vaccine storage, pharmacies have an increasing need for electronic temperature monitoring and alarming.
The lawsuit was joined by Merck, Eli Lilly and Amgen. The companies claim the Department of Health and Human Services does not have the legal authority to force the companies to comply with the new rule.
KB105 is a new gene therapy candidate engineered with a Transglutaminase-1 (TGM1) gene construct to treat TGM1 deficient autosomal recessive congenital ichthyosis
Amarantus Bioscience Holdings, Inc. announced that subsidiary MANF Therapeutics was issued U.S. Patent No. 10,195,251 entitled ‘Methods of Treatment for Retinal Diseases Using MANF and CDNF’ that covers the use of mesencephalic astrocyte-derived neurotrophic factor or cerebral dopamine neurotrophic factor as a treatment for various ophthalmic disorders, including inherited retinal disorders, age-related macular degeneration and glaucoma.
The International Biofilm Summit, addressing the main threat to food contamination, seizes the opportunity of its third edition on 23-24 October to take it to the next level.
BIO’s Jim Greenwood hailed the executive order as an important decision to foster biology-driven solutions to nutrition and improving crop yield.
PRESS RELEASES