
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

Takeda’s acquisition of GammaDelta Therapeutics expands their immuno-oncology and innate immune cell therapy portfolio.

Aceragen’s acquisition of Arrevus adds key treatment candidates to its rare disease pipeline.

Novartis’ scemblix (asciminib) is designed to provide a single treatment option to patients struggling with chronic myeloid leukemia.

Following the acquisition, Avantor will have access to Masterflex’s various bioproduction operations.



Manufacturing capacity expansion is high on the agenda for many bio/pharma companies and service providers in Europe.

Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

The research collaboration between Sartorius and Matica Biotechnology will aim to optimize PAT technologies, automation software, and single-use platforms for large-scale viral vector production.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

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

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

Becton, Dickinson, and Company and partner Aptar’s new plunger stopper will support the injection of biologics into subcutaneous tissue.

Bio-Rad will be launching two new real-time PCR detection tools to be used for in-vitro diagnostic testing.

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.

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.

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).