DS-8201 meets primary endpoint in phase 2 DESTINY-Gastric01 trial

DS-8201 is trastuzumab deruxtecan in Japan and other regions of world barring the US where it is fam-trastuzumab deruxtecan-nxki. The mid-stage trial for the ADC was held in The post DS-8201 meets primary endpoint in phase 2 DESTINY-Gastric01 trial appeared first on Pharmaceutical Business review.

Lexicon Pharmaceuticals announces real-world data on telotristat ethyl’s antiproliferative effects in patients with carcinoid syndrome

XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently The post Lexicon Pharmaceuticals announces real-world data on telotristat ethyl’s antiproliferative effects in patients with carcinoid syndrome appeared first on Pharmaceutical Business review.

HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated lab of future

The integration of a multi-system robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large molecule therapeutics The post HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated lab of future appeared first on Pharmaceutical Business review.

Roche’s Tecentriq fails to meet primary endpoint in MIUC trial

The phase III IMvigor010 study assessing Tecentriq as an adjuvant (after surgery) monotherapy treatment has not achieved its primary endpoint of disease-free survival (DFS) compared against observation in The post Roche’s Tecentriq fails to meet primary endpoint in MIUC trial appeared first on Pharmaceutical Business review.

Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

Tazverik, a methyltransferase inhibitor, has been approved to treat adults and paediatric patients aged between 16 years and older with metastatic or locally advanced epithelioid sarcoma sarcoma not The post Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma appeared first on Pharmaceutical Business review.

LB Pharmaceuticals initiates patient dosing in phase 1 study of LB-102 for treatment of schizophrenia

LB-102 is a novel benzamide designed to be an improved version of amisulpride, a drug successfully used in Europe but unavailable in the United States. The ongoing study The post LB Pharmaceuticals initiates patient dosing in phase 1 study of LB-102 for treatment of schizophrenia appeared first on Pharmaceutical Business review.

Jazz Pharmaceuticals submits NDA for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy

The company redeemed its priority review voucher for the NDA submission. JZP-258 is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or The post Jazz Pharmaceuticals submits NDA for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy appeared first on Pharmaceutical Business review.

Roche’s risdiplam achieves primary endpoint in infant-related spinal muscular atrophy trial

The company has reported positive topline results from the pivotal part 2 of the FIREFISH study, which is assessing risdiplam in infants aged between one and seven months The post Roche’s risdiplam achieves primary endpoint in infant-related spinal muscular atrophy trial appeared first on Pharmaceutical Business review.

FDA approves TEPEZZA for the treatment of thyroid eye disease

TEPEZZA is the first and only FDA-approved medicine for the treatment of TED, a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), The post FDA approves TEPEZZA for the treatment of thyroid eye disease appeared first on Pharmaceutical Business review.

Calidi Biotherapeutics secures series A investments to advance manufacturing

The investment efforts were led by Heehyoung Lee, Ph.D., co-founder and managing partner of LumeBio, advisor to Calidi Biotherapeutics and a fifteen-year veteran in the biopharmaceutical space. Dr. The post Calidi Biotherapeutics secures series A investments to advance manufacturing appeared first on Pharmaceutical Business review.