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Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
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FDA
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
ALS
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
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Cell therapy biotech Artiva Biotherapeutics plans to use the funds raised to support the development of its AlloNK therapy for systemic lupus erythematosus.
GRO Biosciences will use the Series B funds to launch a Phase I trial for ProGly-Uricase, its investigational therapy for gout.
In a bid to take advantage of Humira’s slow loss of market share, Boehringer Ingelheim is offering its biosimilar at a 92% discount exclusively to patients who buy the product on GoodRx.
While its investigational regimen fell short of the primary efficacy endpoint, AVEO dug into data from its control group and touted a “clinically meaningful” improvement in progression-free survival in patients receiving Fotivda monotherapy.
FDA
Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.
Novartis’ second-quarter earnings, announced Thursday, show strong performance of its blockbuster drugs, prompting the company to raise its year-end guidance.
This is the third episode of Denatured’s discussion on diversity, equity and inclusion. Here, our guests discuss imperatives around access and accountability.
Agenus is now looking for alternative pathways to initiate a Phase III trial for BOT/BAL, including potential partnerships.
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future.
As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company.