From WisPolitics.com/WisBusiness.com …
— A Madison-based drug company called Arkayli Biopharma has gotten FDA clearance to proceed with a trial of its lead therapeutic candidate, as well as nearly $3 million in federal research funding.
The business recently announced it has received an approval letter from the federal agency in response to its investigational new drug filing, seeking to conduct a Phase 1b trial of its therapy for infantile hemangioma.
This skin condition is caused by blood vessels forming incorrectly and multiplying early in a baby’s life, often showing up at birth or within the first few weeks after birth. Appearing as a discolored patch of skin, they typically grow quickly in the first five months of life and then stop or start to shrink by one year of age.
While most shrinking happens by the time the child is around 4 years old, nearly half of those with infantile hemangioma retain scar tissue or extra blood vessels on the skin, according to an overview from Johns Hopkins.
Katie MacFarlane, CEO of Arkayli Biopharma, says getting the go-ahead from the FDA for its AKR001 drug candidate “represents a key regulatory milestone for Arkayli and a significant step forward” for babies with this condition and their families.
“ARK001 is designed to address critical unmet needs in this vulnerable patient population, potentially offering a topical approach to treatment of this rare pediatric disease,” MacFarlane said in a statement.
The company has also landed a $2.98 million Small Business Innovative Research grant from the National Heart, Lung and Blood Institute, within the National Institutes of Health. Company leaders are actively raising a Series A financing round.
See more at Madison Startups.
See the release below.
For more of the latest news on the state economy and Wisconsin businesses from startups to industry leaders, sign up today for a free two-week trial of the daily morning news report from WisBusiness.com.
— 1st CD Dem candidate Mitchell Berman criticizes U.S. Rep. Bryan Steil’s healthcare record in a new hospital-set ad.
A Democratic Congressional Campaign Committee spokesperson said the group is putting six figures behind the spot, which first ran yesterday.
AdImpact has tracked $721,557 in reservations by the DCCC for Berman from the primary through Election Day.
“In the ER, I don’t ask you how you vote, I ask where it hurts,” Berman, clad in scrubs and an American flag kerchief, says in the 30-second spot. “And after 16 years as a nurse, I know healthcare costs too damn much.”
Berman tells listeners Steil has taken over $1 million from the drug and insurance industries, and voted to gut healthcare “all to give massive tax breaks to his billionaire donors.”
“I approve this message, because healthcare shouldn’t cost you an arm and a leg,” Berman closes.
Top Stories
– Medical Debt Is Crushing Hospital Patients in Los Angeles. Health Officials May Have a Fix.
– US states label abortion drugs a ‘public nuisance’ in bid to curb access
– Kennedy Plans Federal Vaccine Injury Initiative, Drawing Wary Eye From Experts
– New York governor plans to seek federal help to tackle measles outbreak
– H.I.V. Research Networks Face Uncertain Future Amid Funding Delays
Press Releases
