Pulmonary-Allergy Drugs Advisory Committee votes in favor of what could become the first-approved LAMA/LABA combo for COPD but wants postmarket safety study in patients with more severe cardiovascular disease.
FDA advisors voted 11-2 in favor of approval of GlaxoSmithKline PLC’s Anoro Ellipta for chronic obstructive pulmonary disease Sept. 10, but said the novel combination treatment needs a post-market requirement to better characterize cardiac safety concerns in patients who are more severely ill than those evaluated in clinical trials.
Despite favoring the drug’s approval, many members of the Pulmonary-Allergy Drugs Advisory Committee also said the drug should come with...
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.
Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.
Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.
