Pharmaceutical Technology Editors

Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.

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.

The second part of the CPhI Annual Report has predicted an accelerated rate of change in pharma manufacturing and supply over the coming five years.

MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

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.

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.

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

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.

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.

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.

Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.

Ferrer and Treeway, have entered into a license agreement for the development and commercialization of an oral formulation of edaravone (TW001/FNP122).

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.

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 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.

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