To treat corneal endothelial dysfunction, a condition that causes the outer layer of the eye to swell and go hazy, doctors generally rely on cell transplants.

A highly-trained surgeon rolls out an incredibly thin scroll of cells — around the width of a single strand of hair — from a donor into the patient’s eye, holding it in place with a tiny air bubble.

Each donor can only help one patient, and the patient then has to lie still for at least a day after surgery so as to not disturb the air bubble holding their new corneal endothelium in place.

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As its Covid-19 vaccine application founders at the FDA, Novavax attempted to excite investors Wednesday with its experimental combo Covid/flu shot. But the data remain early, and comments from the FDA reportedly paint a tough road to authorization.

The biotech revealed the first results from its Phase I/II study looking at the two-pronged vaccine, saying the observed immune responses were similar to those produced by each of its standalone shots. As such, Novavax says it plans to launch a “Phase II confirmation trial” by the end of the year.

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For a second year in a row, we’ve launched a 20 under 40 project and arrived, months later, with a list of 21 names.

The reason for that is simple: No matter how much we valorize the lone genius, science is ultimately and always a team sport. Like last year, we set out to honor individuals and found, when we looked, that it was really a team — or in this case a duo — that deserved the recognition.

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Updated results from AstraZeneca’s prevention trial for its long-acting Covid-19 antibody combo Evusheld suggest that the drug is even more effective at the six-month mark, supporting the case for its use to protect those for whom a vaccine may be insufficient.

Whereas the primary analysis on which FDA and EMA regulators granted emergency use authorization had a median follow-up of 83 days, the extended analysis traced them through six months.

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During the Trump administration, FDA and CDC employees said that they did not report political interference in their scientific work because they feared retaliation, among other reasons, according to a new Government Accountability Office report released Wednesday.

The report was released as the FDA’s FOIA office also provided a peek behind the scenes of some of the FDA political appointees’ wheeling and dealing from the last administration, and as former President Trump sought a vaccine authorization prior to the election, and pushed for the controversial hydroxychloroquine EUA decision (later revoked).

In the latest Endpoints MarketingRx advertising matchup, Otsuka and Lundbeck’s Rexulti goes toe to toe with Takeda’s Trintellix with consumers weighing in on the two drugs’ TV commercials for depression.

While the style and tone of the commercials are quite different — Rexulti’s long-running campaign focuses on one person with a sad mask while Trintellix’s work features young people feeling “blah” and “not OK” — the ads still ended up in a close outcome.

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As the war in Ukraine continues to intensify, pharma giant Novartis has detailed its campaign to offer humanitarian relief while sticking to a hard line against Russia.

Since the beginning of the invasion, Novartis has delivered more than 1 million packs of antibiotics, painkillers, cardiovascular and oncology treatments to Ukraine, which amounts to more than $25 million in medical aid, the company said in a statement.

This time last year, Sanofi announced it would spend $476 million on a new vaccine manufacturing site in Singapore, in a move that it said would create 200 new jobs and provide for flexibility in manufacturing multiple vaccines at once. The French pharma giant broke ground on the site Wednesday, and added another $162 million to the price tag.

The site in Singapore is part of Sanofi’s mission to spend $1.3 billion over the next five years to create two sites for pandemic preparedness. The other site will be in its native France. The two will be able to produce between three and four vaccines at once, while current manufacturing sites only allow for the production of a single vaccine.

Another chapter in the PCSK9 battle of Amgen vs. Sanofi and Regeneron is afoot, with the Supreme Court calling on the federal government’s top lawyer to weigh in.

On Monday, SCOTUS invited the solicitor general to file a brief expressing the views of the US on the patent case involving Amgen’s cholesterol drug Repatha as the court considers whether to hear the appeal of a ruling that invalidated Amgen’s patents for the drug.

When the pandemic first hit US shores in early 2020, there was pressure to act quickly, particularly among top biopharma companies like Gilead, Roche and Regeneron. They expeditiously repurposed and developed new Covid-19 treatments, reaping billions along the way.

Thanks to the latest dump of former FDA commissioner Stephen Hahn’s emails and text messages, released via the FDA’s FOIA office, the agency offers a peek behind the curtain on who exactly was reaching out to Hahn and other former Trump political figures, what they were requesting and, thanks to hindsight, how those early efforts paid off.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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