SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.

The planned expansion will expand the capacity of the Charles River Accelerator and Development Lab (CRADL).

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.

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.

The silver-medal ranking is given to companies who demonstrate sustainability practices that place them in the top 20% of companies rated by EcoVadis.

The $19 million contract will expand production capacity of Aptar’s Activ-Film technology, which is used in COVID-19 testing kits.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

ANGUS’ planned expansion will double its tromethamine buffer production capacity.

The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.

The Pharmaceutical Technology and BioPharm International editors host industry experts in serialization and aseptic processing.

Evonik’s LIPEX Flow extruder is a new version of its high-pressure equipment for manufacturing liposomal drug products.

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

Advanced powder testing is a useful tool to differentiate materials and optimize the supply chain.

Aceto will acquire A&C Bio Buffer, including the company’s custom buffer and chemical blend portfolio.