BioPharm News

Oct 19, 2018
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.
Oct 19, 2018
By BioPharm International Editors
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.
Oct 19, 2018
By BioPharm International Editors
The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.
Oct 18, 2018
By BioPharm International Editors
The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.
Oct 18, 2018
By BioPharm International Editors
Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.
Oct 18, 2018
By BioPharm International Editors
The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.
Oct 18, 2018
The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.
Oct 16, 2018
By BioPharm International Editors
The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
Oct 16, 2018
By BioPharm International Editors
The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
Oct 16, 2018
By BioPharm International Editors
The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.
native1_300x100
lorem ipsum