InnovationRx: A Bird Flu Emergency

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For the first time, a patient in the United States has presented with a severe case of avian flu. A man in Louisiana is currently hospitalized with the disease, which he contracted from sick and dead birds from a flock he kept on his property. The virus he was infected with is similar to strains of H5N1 found infecting poultry in the United States, as well as a severe case in another person in British Columbia a few weeks ago. This variety has differences from the strain currently circulating among dairy cattle.

In the meantime, California has declared a state of emergency over the spread of H5N1, which has currently been found in over 640 dairies in the state. “This proclamation is a targeted action to ensure government agencies have the resources and flexibility they need to respond quickly to this outbreak,” Governor Newsom said in a statement.

On the bright side, there still haven’t been any documented cases of avian flu spreading from person to person. Additionally, the federal government has doses of H5N1 vaccines stockpiled, and Moderna entered into a contract with HHS last for development of a bird flu vaccine, which is currently in clinical trials.

P.S. Quick housekeeping note: this will be the last edition of InnovationRx of 2024. We’ll be back on January 8 with a new co-author and a new format. Happy holidays!

This Next Generation IVF Startup Facilitated The Birth Of A Baby For The First Time

Many founders joke that their companies are like their “baby.” But for Dina Radenkovic, that took on a whole new meaning on December 7 when the first baby conceived using her company’s in-vitro fertilization product, Fertilo, was born in Peru.

“Something that came from a very primitive deck in my first New York rented apartment, to an actual baby, it’s certainly a huge emotional journey,” Radenkovic says of the milestone.

Since 1978, millions of babies have been born using in-vitro fertilization (IVF). Last year in the United States, over 2% of all births utilized the procedure. It works, but it’s also lengthy, costly and unpleasant. What’s more, successful egg extractions only work on the first cycle about half of the time for patients under 35 years old (with success rates decreasing to less than 10% for those over 40), which means that many patients have to undergo multiple physically demanding—and expensive—attempts to complete a successful egg retrieval.

These challenges are what inspired Radenkovic to cofound Gameto with Martin Varsavsky in 2021. Both had a background in fertility health. Radenkovic, a physician by trade, had worked in clinical and research roles at places like the National Health Services’ Barts Health and St Thomas’. Varsavsky was a multi-time founder—including of Prelude Fertility, North America’s largest chain of fertility clinics.

Read the whole story here.

Pipeline & Deal Updates

Worm Secretions: Biotech startup Holoclara, which is developing treatments for diseases that are derived from worm secretions, announced that it’s entering into phase 1 clinical trials with its first drug, a potential treatment for the inflammatory disorder eosinophilic esophagitis.

Obesity: AI drug development company Verge Genomics announced it plans to bring a new obesity management pill into clinical trials later this year. The drug is aimed at helping patients who have lost weight with GLP-1s keep the excess weight off.

Gerontology: BioAge Labs has entered into a research partnership with Novartis with a goal of discovering potential targets for age-related diseases. Novartis will pay BioAge Labs $20 million upfront, and the deal calls for up to $530 million in potential milestone payments plus tiered royalties.

Graft vs Host: The FDA has approved remestemcel-L-rknd, marketed by Mesoblast as Ryoncil, for the treatment of pediatric patients with graft-versus-host disease who aren’t responding to steroids.

Non-Opioid Pain Relief: SiteOne Therapeutics, which is developing non-opioid painkillers, announced that it has raised a $100 million series C led by Novo Holdings.

Skin Cancer: The FDA has approved cosibelimab-ipdl, marketed by Checkpoint Therapeutics as Unloxcyt, for aggressive skin cancers that can’t be treated with radiation or surgery.

Brain-Computer Implants: Precision Neuroscience, which is developing an AI-powered brain implant that enables patients with paralysis to operate smartphones, computers and other devices, has raised a $102 million series C funding round.

Third-Ever Pig Kidney Transplant Is A Success

An Alabama woman is in “extraordinary” health after becoming the third living person to receive a pig kidney transplant, NYU Langone Health announced Tuesday, as doctors say the increasingly studied procedure could aid thousands of people waiting for organ donors. The patient was discharged 11 days after the transplant and is evaluated daily at the hospital. So far her renal levels—a measurement of kidney function—appear to be “absolutely normal,” according to the lead surgeon.

The kidney, which was genetically modified to make the organ more receptive to the human body and reduce the likelihood of rejection, was provided by Virginia-based Revivicor, a United Therapeutics subsidiary. It’s one of two companies that have provided pig kidneys for human transplant, the other being Boston-based eGenesis.

Read the whole story.

Other Healthcare News

The FDA is weighing a ban on the artificial food coloring Red No. 3, which has been linked to thyroid cancer in animals and behavioral health issues in children.

Luigi Mangione, the suspect in the fatal shooting of UnitedHealthcare CEO Brian Thompson, has been indicted for first-degree murder and second-degree murder as an act of terrorism.

Infections from dengue viruses have been dramatically increasing over the past two years, but public health officials are concerned about limited options available to treat patients.

Legislation in Congress to regulate pharmacy benefit managers might be good news for pharmacies owned by Walgreens, Walmart, Rite Aid and thousands of independent drugstores.

Across Forbes

What Else We are Reading

Polio vax petition could preview more challenges (Axios)

Truth-teller or reflexive contrarian: Which Marty Makary would run the FDA? (Stat)

Controversial COVID study that promoted unproven treatment retracted after four-year saga (Nature)

Read the full article here

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