News

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

The partnership between Waters and Sartorius aims to accelerate speed and increase accuracy in bioprocessing analysis.

TCR² Therapeutics will add a second clean room to their manufacturing operations.

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021.

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.

Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

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

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

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

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

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.

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.

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.