InnoCare presented data on their drug pipeline at the European Hematology Association (EHA) 2023 Hybrid Congress. The company's orelabrutinib, an inhibitor of Bruton’s Tyrosine Kinase, was evaluated in a study to treat Primary Immune Thrombocytopenia. Results showed that both doses of orelabrutinib were safe for patients with ITP, and those who had previously responded to glucocorticoids or intr..
China Medical System Holdings Limited has announced that the first Diazepam Nasal Spray has been approved for marketing in China, making it the first drug approved in China for the treatment of seizure clusters. The product is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients w..
Precision oncology company Parthenon Therapeutics has had an article published in the Journal for ImmunoTherapy of Cancer (JITC) that identified key characteristics and issues relevant to the role immune exclusion plays in resistance to checkpoint therapy. The work was performed in collaboration with multiple US and international academic institutions. Parthenon recently initiated a Phase 1 tria..
Ferring Pharmaceuticals has been granted approval by the US Food and Drug Administration (FDA) for its ADSTILADRIN intravesical gene therapy manufacturing process. The drug is used to treat non-muscle invasive bladder cancer in adult patients with high-risk Bacillus Calmette-Guérin-unresponsive carcinoma in situ with or without papillary tumors. Ferring intends to make ADSTILADRIN available as p..
Ironwood Pharmaceuticals has announced that LINZESS has been approved by the US Food and Drug Administration (FDA) as a once-daily treatment for functional constipation in pediatric patients aged six to 17 years old. Functional constipation is a chronic condition characterized by hard, infrequent bowel movements that are often difficult or painful to pass, affecting an estimated six million chil..
BIOTRONIK, a global medical technology company specializing in cardiovascular, endovascular and neuromodulation solutions, has announced the first implantation of its BIOMONITOR IV implantable cardiac monitor (ICM) with artificial intelligence (AI). The device pairs SmartECG technology with AI to reduce false positive detections by 86%, while preserving 98% of true episodes. It is also capable o..
The FDA is preparing for a surge in cell and gene therapy submissions, with up to 10 regulatory decisions expected this year alone. The establishment of the Office of Therapeutic Products (OTP) is part of the FDA's response to the growing demand for regulatory review of these therapies. However, experts have warned that modernization of both the regulatory and access and reimbursement frameworks..
The FDA has four target action dates this week, including approvals for drugs to treat functional constipation, Alagille syndrome, myelofibrosis and symptomatic obstructive hypertrophic cardiomyopathy. Ironwood Pharmaceuticals' Linzess is set to be approved as a treatment for functional constipation in children aged 6-17 years on June 14th. Albireo's Bylvay may also receive approval on June 15th..
The U.S. Chamber of Commerce has filed a lawsuit against the Department of Health and Human Services and Centers for Medicare & Medicaid Services in federal court, challenging the constitutionality of the Inflation Reduction Act’s drug price negotiation program. The lawsuit claims that the IRA violates the Constitution's "requirements of limited government, property rights, the rule of law, and ..
