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 ..
Illumina CEO Francis deSouza has resigned from his position, effective immediately. The announcement comes after activist investor Carl Icahn attempted to place three representatives on Illumina's board ahead of the annual shareholder meeting last month. Icahn criticized deSouza's leadership and the incumbent board's failure to maximize value for shareholders, specifically pointing to the 2020 a..
Pharmaceutical companies and pharmacies have agreed to pay $19 billion in an opioid settlement with state and local governments, settling lawsuits alleging that Allergan, Teva Pharmaceuticals, CVS, Walgreens, and Walmart drove the opioid epidemic. The settlement comes after AbbVie (through Allergan) and Teva were set to pay some $5 billion to settle about 3,500 opioid lawsuits more than a year a..
Swiss pharmaceutical company Novartis has announced its acquisition of kidney player Chinook Therapeutics for $3.5 billion, in a bid to expand its renal drug portfolio. The deal includes an upfront cash payment of $3.2 billion and up to $300 million in contingent value rights, payable once certain regulatory milestones are achieved. The acquisition will give Novartis access to Chinook's two late..
Gene editing companies Editas Medicine, Vertex Pharmaceuticals and CRISPR Therapeutics are all racing to develop treatments for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Editas recently unveiled early data from its RUBY and EdiTHAL trials, demonstrating the potential of its gene editor EDIT-301 in treating these diseases. However, Vertex and CRISPR also released posit..
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has voted 6-0 in favor of granting full approval to Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. The decision is expected to result in full FDA approval on or before July 6th, as the agency usually follows its advisory committees' recommendations. The FDA released briefing documents that ..
