April 14, 2023

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Biotech Correspondent

A malaria vaccine developed at the University of Oxford gets approval in Ghana for small children, Lilly's ulcerative colitis drug does not get an approval, and how bear blood could be the key to understanding blood clots.

global health
Oxford's malaria vaccine approved in Ghana
Ghana has become the first country to approve a new malaria vaccine, made by University of Oxford, for small children.

Though a timeline for the vaccine's rollout hasn't been set, Ghana's FDA has sanctioned it for children aged 5 months to 36 months, which is when children are most susceptible to the malaria parasite. Although final trial results still haven't been published, data so far suggest the vaccine is extremely effective — much more so than a GSK malaria vaccine already approved by the WHO.

An earlier trial in Burkina Faso showed that the vaccine was up to 80% effective in preventing malaria in kids, depending on how strong the dosage was. The GSK vaccine, Mosquirix, seems to be about 30% effective. The Serum Institute said it could potentially manufacture more than 200 million doses per year, at a relatively low price point, in a factory based in Ghana.

The WHO is still reviewing the new University of Oxford inoculation.

podcast

Is pharma facing an existential threat?

How do you follow inventing a Covid-19 vaccine? And what did we learn from biotech's unicorn era? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

Jeremy Levin, CEO of Ovid Therapeutics, joins us to discuss a judge's decision to overturn the FDA approval of an abortion pill and why he believes it's the biggest threat to the biopharma industry in 50 years. We also cover the biggest news in the week of biopharma, including an update from Moderna, dispatches from a trip to FDA headquarters, and who Sen. Bernie Sanders has in his sights next.

Listen here.

RESEARCH

Bears... beat... blood clots

When humans are immobilized, be it by coma or paralysis or debilitating infection, they can develop blood clots that are potentially fatal. Yet when hibernating bears lay in repose for months on end, their blood doesn't congeal. Scientists have been studying this phenomenon, and think that bear blood could hold a key to help prevent venous thromboembolisms in people.

A platelet protein called HSP47 helps with wound healing — but in bears, the molecule all but disappears during the hibernation months. Researchers want to develop drugs that block HSP47, and though it's early days for this work, they say potential could be vast.

"The bear has solved most of the health challenges faced by humans," said Swedish cardiologist Ole Robert, who has long studied why hibernating animals don't suffer from stasis the way humans do. "They barely lose muscle or bone mass, they don't develop bed sores, kidney failure and what have you… Bears avoid all the conditions that our present sedentary life is associated with."

FDA DECISIONS
A roadblock for Lilly's ulcerative colitis drug

The FDA yesterday declined to approve Eli Lilly's experimental ulcerative colitis drug, mirikizumab — issuing a complete response letter that cites issues with the drug's proposed manufacturing process. Regulators didn't have any concerns with the clinical data that back the antibody drug, nor did they have concerns with safety or labeling, the company said. Still, it's a blow to the pharma giant, which has been gearing up for an approval in recent months — and still expects to get one.

Mirikizumab did receive approval recently in Japan and it seems likely the European Medicines Agency will follow suit.

Despite Lilly's best efforts, investors haven't been particularly bullish about the drug. Johnson & Johnson, AbbVie, and AstraZeneca all have their own antibody drugs that are being tested in ulcerative colitis, creating stiff competition for mirikizumab, if and when it's approved.

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