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Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Trial

Astellas Pharma Inc. and Seagen Inc. announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating the antibody-drug conjugate PADCEVยฎ (enfortumab vedotin-ejfv) for patients...

Merck Licenses CRISPR Genome-Editing Technology to PanCELLa and Takara Bio USA

Merck, a leading science and technology company,ย  announced that it has signed agreements licensing its CRISPR technology to two companies โ€” PanCELLa, a cell therapy firm based in Toronto, Canada and Takara Bio USA, Inc., a biotechnology company based...

Direct Biologics Granted Expanded Access by FDA for ExoFlo in the Treatment of COVID-19

Direct Biologics, LLC, announced that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated acute respiratory distress syndrome (ARDS). While Direct Biologics is already enrolling patients in EXIT COVID-19, its national multi-center, Phase...

Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

AstraZenecaโ€™s long-acting antibody (LAAB) combination, AZD7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are due to begin in the next weeks. The LAABs have been...

Gilead Sciences signs joint procurement agreement with the European Commission for Veklury (remdesivir)

Gilead Sciences and the EC signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Vekluryยฎ (remdesivir), the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union (EU)....

Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients

Regeneron Pharmaceuticals, Inc. announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19....

BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1

BryoLogyx, Inc., announced that it has completed the synthesis of bryostatin-1 molecule, pursuant to FDAโ€™s Good Manufacturing Practice (GMP) regulations. Bryostatin-1 is the companyโ€™s lead compound being developed to improve patient outcomes by amplifying the response and increasing the...

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