Archive for June 2024

The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine), the first inhaled maintenance chronic obstructive pulmonary disease (COPD) drug in more than two decades, and granted marketing authorization of a novel in-office hepatitis C virus (HCV) test that will allow clinicians to receive rapid results and address the issue in one visit. Source: Drug Industry Daily

Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Source: Drug Industry Daily

This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list of recognized standards and is seeking comments on its IT and customer experience strategies. Source: Drug Industry Daily

This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s purchase of Silk Road Medical. Source: Drug Industry Daily

Several Philips BiPAP devices and certain Baxter Life2000 ventilator systems are under FDA Class I recalls, the most serious type of recall, as use of the devices can result in serious injury or death. Source: Drug Industry Daily

Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday. Source: Drug Industry Daily

Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them to report adverse events directly to the FDA’s MedWatch reporting system. Source: Drug Industry Daily

This month Takeda struggles to find the bright side of disappointing phase 3 data, Pfizer touts “unprecedented” lung cancer success, NS Pharma’s Duchenne muscular dystrophy drug fails in phase 3, and GLP1-agonists are not only reducing mortality, but getting a subdermal device makeover. Source: Drug Industry Daily

Merck and Daiichi Sankyo’s non-small cell lung cancer drug suffered a setback with the companies’ receipt of an FDA complete response letter (CRL) identifying third party manufacturer inspection issues as the reason for rejecting the drug application. Source: Drug Industry Daily

The ongoing effort by the FTC to remove what it labels improper and inaccurate — or “junk” — listings of drug patents in the FDA’s Orange Book continues, with all cited drugmakers refusing to delist the 300 patents called out by the commission on April 30. Source: Drug Industry Daily