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Swedish biologics site a factor in Q1 margin decline, says AZ

AstraZeneca says the build-up of biologics manufacturing capacity at its yet-to-launch facility in Sweden has contributed to a reduced core gross margin this quarter.

US FDA green light for Samsung BioLogics’ mAb production

The US FDA has granted Samsung BioLogics’ second manufacturing plant another approval for monoclonal antibody production.

Sandoz wins EU approval for Remicade biosimilar

The European Commission has approved Sandoz’ Zessly (infliximab), a biosimilar version of J&J’s Remicade.

WuXi Biologics expands manufacturing to Singapore with $60m facility

WuXi Biologics is expanding its manufacturing site network to Singapore with the construction of a $60m facility for clinical and small volume commercial production.

Cellectis submits IND to US FDA for ‘off-the-shelf’ UCART22

Cellectis has submitted an IND for off-the-shelf T-cell candidate UCART22, an allogeneic investigational therapy designed to treat leukemia.

Stem cell clinic to ‘vigorously defend’ US FDA lawsuit

The US Department of Justice has filed a lawsuit to stop US Stem Cell Clinic from performing autologous stem cell procedures at the request of the US Food and Drug Administration (FDA).