Articles

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

NIH and FDA Lead Coalition to Accelerate Gene Therapy Development for Rare Diseases

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.

CPhI Report Predicts Accelerated Rate of Change in Pharma Manufacturing and Supply Over Next 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.

MHRA Grants License to Gedeon Richter for Combination Therapy to Treat Uterine Fibroids

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.



Partnership Aims to Accelerate and Improve Smart Bioprocess Development Solutions

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 Advisory Committee Votes in Favor of EUA for Pfizer-BioNTech COVID-19 Vaccine in Children 

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

Merck and MPP Enter Into License Agreement for Investigational Oral Antiviral COVID-19 Medicine

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.

SGS Opens New Clinical Research Site in Belgium and Expands Biosafety Testing Capacity in UK

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

FDA Acknowledges Hurdles in Utilizing Real-World Data

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

Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children 

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

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