Industry 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 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.
Oct 16, 2018
By BioPharm International Editors
According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.
Oct 12, 2018
By BioPharm International Editors
A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.
Oct 10, 2018
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
Oct 05, 2018
By BioPharm International Editors
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
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