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

Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation. 

Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

The new appointments to the top jobs at NICE may bring continuity at a challenging time for the institute, but perhaps not the real change that some in the industry say is needed. 

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.

In a bid to ensure long-term medicines security, the Indian government has earmarked $1.32bn to promote domestic production of 53 APIs, including lopinavir and ritonavir currently being evaluated to treat COVID-19 cases, as well as antibiotics, for which India is highly dependent on China.

What's in – and what fell out of – the massive US stimulus package.

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

The European Medicines Agency’s first management board meeting of 2020 was held virtually and was shortened but covered a number of topics including COVID-19.

US FDA has granted about 250 COVID-19 patients expanded access to Gilead’s investigational antiviral; the adaptive trial now underway in US aims for 400 patients.

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

A joint meeting of the US FDA and the FTC on biosimilar competition may have delivered a symbolic message about the need for a ‘level playing field’ in the biologics market – but it did not deliver much in the way of an actionable agenda for antitrust regulators.

Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage. 

Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.