The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that the class risks are being added to its label for their rival drug, which will now be relegated to second-line use.

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A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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CANNES – When Olympic gold medalist Tianna Bartoletta went to the hospital to deliver her son last year, she packed signed advanced directives and her will in her bag. Why? Her past experience with the healthcare system while training for the 2020 Tokyo Olympics.

She was training in sprint and long jump — after winning two golds in 2016 and one in 2012 — when she began to notice changes in her period. While Bartoletta initially rationalized it as stress or training too hard, it kept getting worse — to the point where she had dizzy spells and episodes of passing out. So she went to the doctor.

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CANNES —  As a young scientist, Sommer Bazuro was looking at oncology data when she realized that the patient population was not at all representative of the demographics most likely to suffer and die from cancer.

Thinking it must be an isolated incident, she turned to peer-reviewed publications and began talking to oncologists, only to discover that a lack of diversity in clinical trials was par for the course. Black and Hispanic patients typically don’t even reach levels of representation consistent with the general population.

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While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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