Drug Manufacturing

Assembly Bio and Gilead collaborate to advance antiviral therapeutic programmes

Assembly Biosciences has received an investment from Gilead Sciences, comprising a $20.1m equity investment and $10m in accelerated funding, to propel the clinical development of new antiviral therapies targeting herpesviruses, hepatitis B virus (HBV), and hepatitis D virus (HDV).

Agios announces EC’s positive decision for sickle cell disease therapy designation

The European Commission (EC) has adopted a positive decision for designating Agios Pharmaceuticals’ oral, small molecule pyruvate kinase (PK) activator, mitapivat, as an orphan medicinal product (OMP) for treating sickle cell disease.

Akamis secures funds to advance cancer therapy through study

Akamis Bio has secured $60m in funding, marking the close of a Series A Prime financing round, which will propel the development of its clinical candidate, NG-350A, for treating locally advanced rectal cancer (LARC), through study.

Candid partners with EpimAb to develop T-cell engager candidates

Candid Therapeutics has entered into a strategic research partnership with EpimAb Biotherapeutics to discover and develop new T-cell engagers (TCEs) for different types of autoimmune diseases.

Sanofi’s multiple sclerosis therapy gains breakthrough therapy status from FDA

Sanofi’s oral bioactive Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib has gained breakthrough therapy designation from the US Food and Drug Administration (FDA) for treating the adult population with non-relapsing secondary progressive multiple sclerosis (nrSPMS).

Tanner-Agenus partner for expanded access to immunotherapies for cancer patients

Tanner Pharma has partnered with Agenus to offer expanded access to investigational immunotherapies, botensilimab (BOT) and balstilimab (BAL), for individuals with microsatellite stable colorectal cancer (MSS CRC) and other advanced solid tumours.

ProQR expands partnership with RSRT to advance Rett Syndrome therapy

ProQR Therapeutics has expanded its partnership with the Rett Syndrome Research Trust (RSRT), receiving an additional $8.1m in funding to support the advancement of Rett Syndrome therapy, AX-2402 into clinical trials.

Orthogon secures funding to boost BK virus treatments for transplant patients

Orthogon Therapeutics has closed an oversubscribed $5.2m in funding to expedite the development of new treatments for handling the reactivation of BK virus in transplant patients.

FDA accepts Crinetics Pharmaceuticals’ NDA for acromegaly treatment therapy

The US Food and Drug Administration (FDA) has accepted Crinetics Pharmaceuticals' paltusotine new drug application (NDA) as a long-term maintenance and potential treatment for acromegaly in the adult population.