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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Complicated biomolecules call for alternative drug delivery strategies.
Data management strategy is important for generating successful analytical studies.
Early control architecture decisions impact a facility’s long-term capabilities.
Bioassay studies for biosimilars enables regulatory pathway.
Large-scale SUBs prove successful as limits are tested.
AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint
October 22, 2021
Spectrum Chemical scientists give a shout-out to 10 chemicals impacting quality of life in conjunction with National Chemistry Week.
Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.
The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.
A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.
Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.
EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.
EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.
EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.
UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.
October 21, 2021
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.