News
Expansion across its network will mean hundreds of new employees in Cincinnati, increased ability to get complex medicines to patients and more.
FEATURED STORIES
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
Job Trends
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
BioSpace spoke with representatives of the two top-place finishers in our Best Places to Work list about their approaches to fostering an engaging workplace.
While Regeneron Pharmaceuticals reported better-than-expected third-quarter results, sales of the company’s lead drug Eylea declined amid increased competition.
The New York-based genetic medicine company, which expects gross proceeds of approximately $100 million, joins a small group of biotechs that have launched initial public offerings this year.
The U.S. government has requested that a Delaware federal judge deny an AstraZeneca motion for summary judgement in its Inflation Reduction Act case, arguing that the company’s core claims are meritless.
In a late-stage study, most Huntington’s disease patients reported that their symptoms of chorea were “much improved” or “very much improved” following treatment with Neurocrine Biosciences’ VMAT2 inhibitor Ingrezza.
While Moderna’s total revenue for the third quarter beat analyst expectations, the company Thursday reported a loss as demand for its COVID vaccines declined.
A recent report by Tufts Medical Center reveals impressive approval rates for durable cell and gene therapies, but experts urge caution over persistent safety and accessibility concerns.
Sales of type 2 diabetes treatment Mounjaro brought in $1.4 billion in the third quarter. However, the company cut its full-year profit guidance due to charges mainly related to recent acquisitions.
Riding a wave of skyrocketing Wegovy and Ozempic sales, the company on Thursday raised its sales and operating profit outlook for the rest of the year as part of its third-quarter earnings announcement.
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.