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Medicare Price ‘Negotiation’ : Manufacturer Compliance Gets Tougher Enforcement Provision

As legislation authorizing Medicare price 'negotiation' clears the Senate and appears on its way toward enactment after years of efforts by US congressional Democrats, and opposition by Republicans and the pharmaceutical industry, the bill continues to be tweaked.

Pricing Debate Medicare

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

US FDA Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’

Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.

FDA Leadership

Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx

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.

United States Clinical Trials

Lilly Needs Updated FDA Authorization To Sell COVID Antibody On Commercial Market

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.

United States Biologics

Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos

Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.

Vaccines Review Pathway

US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time

Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.

User Fees Review Pathway

New COVID Therapeutic Development Hitting Regulatory Wall At US FDA

FDA trial design criteria pose challenges for new COVID therapeutic development, frustrating companies and NIH and prompting a tense meeting earlier this summer, according to audio obtained by the Pink Sheet.

Coronavirus COVID-19 Clinical Trials

Global Pharma Guidance Tracker – July 2022

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All

Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.

United States Clinical Trials

Don’t Look Up? Congress Can’t Ignore Risk To Small Molecule Drugs In Pricing Bill, Investors Warn

A budget-neutral fix that would extend the time before small molecule drugs are subject negotiations but increase the minimum discounts for the products is floated as the pricing legislation moves toward a Senate floor vote.

Pricing Debate Medicare

Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Approvals Biosimilars
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