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

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

New supply arrangements with the two firms are expected to offer greater protection to people in Europe as the autumn/winter season approaches. The EU’s health crisis preparedness body HERA has also identified its “top three health threats.”

Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.

The company has filed its first drug in the UK and initiated a US-based Phase III trial; US drug pricing legislation underscores the company's value proposition, CEO argues, since payers will still be under pressure.

China's largest physician portal DXY has been banned from posting on a major social media platform after naming a new zoonotic virus after the place where it originated.

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.

A special podcast looks at the implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps, of the US Supreme Court’s historic overturning of Roe v. Wade.

Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.

A coordinated effort will be needed if Africa is to increase its manufacturing capacity and ensure a market for domestically produced vaccines.

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.