News

Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.

EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.

MilliporeSigma’s newly launched Millicell DCI Digital Cell Imager quickly and objectively assesses common cell culture parameters and growth trends for more consistent cell cultures.

The $691 million deal will see Vertex use Mammoth’s systems to discover and develop in-vivo gene-editing therapies.

Global CDMO, ten23 health, has acquired filling technology and drug product manufacturing expert, swissfillon, enhancing its integrated offering.

The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.

Merck’s agreement with the Medicines Patent Pool (MPP) aims to facilitate affordable global access for molnupiravir.

The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.

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

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

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

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.

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.

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.