BioPharm International Editors

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

ANGUS’ planned expansion will double its tromethamine buffer production capacity.

The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.

The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future.

Aceto will acquire A&C Bio Buffer, including the company’s custom buffer and chemical blend portfolio.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.

This acquisition grants Bionano access to BioDiscovery’s clinical software solution for variant analysis.

Pharmalex has launched the Biopharma Excellence brand, a new service line that combines the expertise of PharmaLex, ERA Consulting, and Biopharma Excellence.

SGS is investing in a new E&L lab in Navi Mumbai, India, that will provide testing services.

AION Labs will be a first-of-its-kind AI/pharma and computational biology innovation lab aimed at spearheading the adoption of AI technologies and computational science.

Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.

Element’s acquisition of Nanosyn is the latest in a series of moves made to strengthen the company’s North American presence.

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

Pacira’s acquisition grants them access to Flexion’s pain management portfolio.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.

MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, signed an agreement with Cellecta to license its genome-editing tool.

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.