Biopharma News

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.

Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.

CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.

Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.

Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.

MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.

Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.

Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.

Thermo Fisher Scientific’s new 300,000 ft² facility, located in Plainville, Mass., will specialize in manufacturing viral vectors.

Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.