Drug Manufacturing

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.

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

Torii Pharmaceutical has submitted a new drug application (NDA) for TO-208 in Japan, targeting the treatment of molluscum contagiosum, a common and highly contagious skin disease.

MindMed receives innovation passport for GAD therapy from UK MHRA

Mind Medicine (MindMed) has received the innovation passport designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its MM120 Orally Disintegrating Tablet (ODT) as a potential treatment for generalised anxiety disorder (GAD).

Theratechnologies to license Ionis’ RNA-targeted therapies in Canada

Theratechnologies has entered into a licensing agreement with Ionis Pharmaceuticals to acquire exclusive Canadian rights for two investigational RNA-targeted medicines, olezarsen and donidalorsen.

Gilead and Tubulis sign ADC development deal for cancer treatment

Gilead Sciences has entered into an exclusive option and license agreement with German biotechnology company Tubulis to develop an antibody-drug conjugate (ADC) aimed at treating solid tumours.