Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.

While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.

The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.

An updated National Pharmaceutical Policy aimed at enhancing India’s self-reliance and global competitiveness is on the cards. A focus on private-public partnering and academia-industry linkages means much of its success will depend on the ability of various parties to deliver within the constraints they operate in

After years of discussions, Japan has revised legislation relating to the use of medicines containing cannabinoids, while also officially criminalizing the non-medical use of marijuana. The move may pave the way for easier use of medicines such as Epidiolex, for which a local Phase III trial started in 2022.

Research takes deep dive into the implications around exempting certain orphan drugs that may qualify for the Inflation Reduction Act’s Medicare price negotiation program, including the effect of the exemption on Medicare spending and the revenue potential of those drugs.

Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

John Crowley will take the reins at BIO in March, about a year and a half after the departure of former CEO Michelle McMurry-Heath was announced.

Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.

The scheme still includes high rebate rates, but a controversial life cycle adjustment mechanism has been dropped.

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

With the only FDA-approved treatment off the market, the FDA is looking for ideas for development of new preterm birth treatments.