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While Baseline Therapeutics declined to disclose its starting capital, the startup said it will use the funds to push its GLP-1 asset BT-001 into late-stage development, with two trials planned this year.
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Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.
The contract manufacturer plans to expand its U.S. footprint with a former Roche facility in Vacaville, California, which Lonza contends is one of the largest biologics manufacturing facilities in the world by volume.
A string of rejections prompt some to look beyond research roles in the biopharma industry as they seek to launch a career.
Bristol Myers Squibb secured another late-phase immuno-oncology victory Wednesday, showing that the combination of Opdivo and Yervoy improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche.
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
Under the European Union’s proposed regulations, companies will have data protection for at least seven-and-a-half years preventing competitors from accessing their product data.
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand.
Takeda on Tuesday secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
President Joe Biden has made drug pricing a cornerstone of his campaign, but former President Donald Trump also plans to target drugmakers if he reenters the White House.
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.