Drug Manufacturing December 19, 2024 Agios announces EC’s positive decision for sickle cell disease therapy designation By PBR Staff Writer This follows orphan drug status granted by the US Food and Drug Administration (FDA) in November 2020. Currently, mitapivat is approved in the US under the brand name
Drug ManufacturingOncology December 18, 2024 Akamis secures funds to advance cancer therapy through study By PBR Staff Writer The investment will specifically support the development of NG-350A through a Phase Ib clinical proof-of-concept study, FORTRESS which will assess the clinical complete response rates of the therapy
Drug Manufacturing December 17, 2024 Candid partners with EpimAb to develop T-cell engager candidates By PBR Staff Writer Under the agreement terms, EpimAb is set to receive an upfront payment, along with development and sales milestones that could exceed $1bn, provided multiple drug candidates reach commercialisation.
OncologyDrug ManufacturingCentral Nervous System December 16, 2024 Sanofi’s multiple sclerosis therapy gains breakthrough therapy status from FDA By PBR Staff Writer The designation is supported by the positive outcomes from the double-blind Phase III HERCULES trial, where the therapy showed a 31% delay in the time to onset of
Drug ManufacturingOncology December 13, 2024 Tanner-Agenus partner for expanded access to immunotherapies for cancer patients By PBR Staff Writer This initiative is facilitated through a Named Patient Program (NPP), allowing patients to access these treatments based on clinical evidence and medical needs prior to regulatory approval. The
NeurologyDrug Manufacturing December 12, 2024 ProQR expands partnership with RSRT to advance Rett Syndrome therapy By PBR Staff Writer The total funding is set to amount to $9.1m and the initial research grant of $1m was announced in January this year. The additional funding from RSRT will
Drug Manufacturing December 11, 2024 Orthogon secures funding to boost BK virus treatments for transplant patients By PBR Staff Writer With this financing round, the company’s total funding reached more than $25m. Small molecule drugs developed by the company specifically target viral proteins crucial to the polyomavirus life
Drug ManufacturingOncology December 10, 2024 FDA accepts Crinetics Pharmaceuticals’ NDA for acromegaly treatment therapy By PBR Staff Writer Acromegaly is a serious disease which is generally caused by a benign pituitary adenoma. Paltusotine would be the first, once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist
DermatologyDrug FilingDrug Manufacturing December 9, 2024 Torii submits NDA for molluscum contagiosum treatment therapy in Japan By PBR Staff Writer TO-208, known as VP-102 in the US and marketed under the brand name YCANTH, contains cantharidin as its active ingredient. A Phase III clinical trial was conducted in
Drug ManufacturingCentral Nervous System December 6, 2024 MindMed receives innovation passport for GAD therapy from UK MHRA By PBR Staff Writer This designation marks the beginning of the UK Innovative Licensing and Access Pathway (ILAP), which is designed to expedite the development and access of new medicines in the