Top News

Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 21, 2017
By BioPharm International Editors
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
Oct 31, 2017
By BioPharm International Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
Oct 26, 2017
By BioPharm International Editors
The new BioLive event, which will be a global hub for biopharmaceutical manufacturing, will launch alongside CPhI Worldwide 2018 in Madrid.
Oct 25, 2017
By BioPharm International Editors
Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.
Oct 25, 2017
By BioPharm International Editors
Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.
Oct 20, 2017
By BioPharm International Editors
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
Oct 13, 2017
By BioPharm International Editors
Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
Sep 28, 2017
By BioPharm International Editors
AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
Sep 19, 2017
By BioPharm International Editors
The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
native1_300x100
lorem ipsum