A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.

Vertex’s fertility preservation assistance program would provide up to $70,000 in financial support for in vitro fertilization and other services to patients prescribed Casgevy.

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

But the overall impact of the Supreme Court decision may not seem as “immediate” in 340B compared to other federal programs.

US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

In long-running litigation over perindopril ‘pay for delay’ settlements, appeals have been refused and certain earlier findings by Europe’s general court have been set aside in a fresh ruling by the Court of Justice of the EU.

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

In a 5-4 decision, the high court says a Chapter 11 bankruptcy plan provision releasing the Sackler family from future liability is not allowed, a decision that could spur a bolus of personal injury trials if another reorganization plan settling thousands of claims cannot be reached.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

Drug maker pursuing novel approach to establishing that contract pharmacies are improperly taking ‘title’ to 340B-discounted drugs, leading to diversion, which is prohibited by law.

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

In long-running litigation over perindopril ‘pay for delay’ settlements, appeals have been refused and certain earlier findings by Europe’s general court have been set aside in a fresh ruling by the Court of Justice of the EU.

The R&D-based pharma industry has welcomed the “more careful and considered approach” taken by EU ministers to the European Commission’s proposed compulsory licensing system, but says there is room for further improvement.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.

A bill that would prevent product hopping was estimated to save US taxpayers $3bn by the US Congressional Budget Office, increasing the likelihood it could be enacted to help pay for other congressional priorities.

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).