In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.

Pink Sheet reporters and editors discuss Viatris receiving the first interchangeable biosimilar designation, CMS hearing from stakeholders about Aduhelm and other Alzheimer’s drugs, and concerns about expanding pediatric coronavirus vaccine trials to look for rare adverse events.

ICER discussion on the health benefit of several upcoming drugs for atopic dermatitis, including several JAK inhibitors, touches on safety concerns and the likelihood that increased competition will open the door to higher list prices and rebating in the class.

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

ICER discussion on the health benefit of several upcoming drugs for atopic dermatitis, including several JAK inhibitors, touches on safety concerns and the likelihood that increased competition will open the door to higher list prices and rebating in the class.

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

The Netherlands calls for multi-country price negotiations for gene therapy Zynteglo.

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.

The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.

Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

The European Medicines Agency has updated its reflection paper on methodologies for comparative quality assessment. The paper clarifies expectations on the assessment of similarity for manufacturing changes and for generic and biosimilar development by introducing the concept of “similarity condition.”

BARDA and Development Financing Corp. officials provide insights into window of opportunity for partnering on manufacturing scale-up.

Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.