Research & Development

J&J’s Rybrevant Faspro gains FDA approval for new dosing in NSCLC

Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for a new monthly dosing schedule for the combination therapy Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) to treat patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Teijin and Aska Pharmaceutical agree for gynaecological drug development

Teijin Pharma has signed a joint research agreement with Tokyo-based Aska Pharmaceutical to develop small-molecule drug candidates for gynaecological diseases.

ExCellThera secures German NUB Status 1 listing for Zemcelpro

ExCellThera and its wholly owned subsidiary Cordex Biologics have received a Status 1 listing from the Neue Untersuchungs- und Behandlungsmethoden (NUB) programme in Germany for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.

FDA issues complete response letter to Disc Medicine’s bitopertin NDA

Disc Medicine has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its new drug application (NDA) for bitopertin for erythropoietic protoporphyria (EPP).

Immunic secures $400m fund to support commercial-stage development

Immunic has announced an oversubscribed private placement of up to $400m, strengthening its move from an R&D-focused organisation into a commercial-stage entity.

Ampersand Capital acquires Purna Pharmaceuticals

Ampersand Capital Partners has acquired Purna Pharmaceuticals, a Belgium-based provider of development and manufacturing services for liquid and semi-solid dosage forms in the pharmaceutical sector.

MSD receives FDA approval for Keytruda combo to treat ovarian cancer

MSD has received the US Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), along with paclitaxel, with or without bevacizumab, for ovarian cancer.

THX Pharma and Biocodex sign licensing deal for Batten-1 and TX01 drugs

THX Pharma (Theranexus) and Biocodex have entered a strategic licensing agreement to further the development of two drug candidates, Batten-1 and TX01, targeted at the Batten, Gaucher, and Niemann-Pick type C rare diseases.

Insilico and CMS launch drug discovery collaborations for CNS diseases

Insilico Medicine has announced several AI drug discovery collaborations with China Medical System (CMS) across several projects in central nervous system (CNS) and autoimmune diseases.