Industry News

Oct 11, 2017
By BioPharm International Editors
FDA published guidance on the format and content of REMS documents.
Oct 11, 2017
By BioPharm International Editors
The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.
Oct 11, 2017
By BioPharm International Editors
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
Oct 11, 2017
By BioPharm International Editors
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Oct 11, 2017
By BioPharm International Editors
Europe updates the guideline on excipients information in labeling and packaging.
Oct 11, 2017
By BioPharm International Editors
BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.
Oct 05, 2017
By BioPharm International Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Oct 05, 2017
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
Oct 04, 2017
By BioPharm International Editors
Genentech, AmerisourceBergen, and McKesson are providing pharma user requirements for a new project that will evaluate blockchain‘s potential in meeting requirements of the Drug Supply Chain Security Act, and preventing pharmaceutical counterfeiting.
Oct 04, 2017
By BioPharm International Editors
Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.
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