ADVERTISEMENT
 |
|
|
Top Stories
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.
/ read more /
World Health Organization's Ebola ring vaccination uses Merck & Co.'s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.
/ read more /
|
|
SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
subscription offers
|
|
|
|
ADVERTISEMENT
 |
|
|
Industry News
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
/ read more /
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
/ read more /
More Industry News
|
|
|
|
ADVERTISEMENT
 |
|
|
Biopharma News
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
/ read more /
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson's blockbuster Remicade (infliximab).
/ read more /
More Biopharma News
|
|
|
Supplier News
FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.
/ read more /
Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.
/ read more /
More Supplier News
|
|
|
Regulatory News
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
/ read more /
|
|
|
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
/ read more /
More Regulatory News
|
|
|
|
ADVERTISEMENT
IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
 Read more
|
|
|
|
FEATURED TOPICS
|
|
STANDARDS & REGULATIONS
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
/ read more /
|
|
|
|
|
MANUFACTURING
The development of emerging therapies poses unique manufacturing and formulation challenges for drug developers as candidates like cell and gene therapies advance through the pipeline.
/ read more /
|
|
|
|
ADVERTISEMENT
Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, "hands-on" training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.
 Read more
|
|
|
|
Events
June 4–7, 2018
June 7–8, 2018
June 14–15, 2018
more events
|
|
|
eBook
|
How are contract development and manufacturing contract service organizations meeting the development and manufacturing needs of innovator biopharmaceuticals and biosimilars companies? In this BioPharm International ebook, the editors examine trends, partnerships, manufacturing capacity, regulatory, supply chain, and technical expertise issues.
|
|
|
|
|
|
