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The global contract development and manufacturing organization is investing $1.2 billion to boost production capabilities at its Holly Springs, North Carolina, site including mammalian cell culture bioreactors.
FDA
The FDA on Thursday approved the label expansion of AstraZeneca’s Fasenra as an add-on maintenance treatment for severe eosinophilic asthma in patients six to 11 years of age.
Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide.
Data presented at the American Association for Cancer Research’s annual meeting sparked hope that we could be getting closer to treating pancreatic cancer, glioblastoma and other particularly difficult tumors.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.
Moderna Thursday said it paused plans to build an mRNA manufacturing facility in Kenya to buy time to assess vaccine demand after being hit with $1 billion in losses and write-downs due to canceled orders.
Novartis on Thursday announced that it is making $150 million in upfront payments to protein degradation biotech Arvinas, while separately revealing that its tender offer for MorphoSys has begun.
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
On the heels of withdrawing Relyvrio from the U.S. and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035.
Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.
The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.
While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, we discuss the many areas where trials can be improved, such as human and historical diagnosis and screening biases, accessibility, data capturing, and more
Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first,” but there are more mid- to late-stage therapies showing promising results.
Bristol Myers Squibb-backed TORL BioTherapeutics announced Wednesday it will use proceeds from the Series B-2 financing round to advance its pipeline of antibody-drug conjugate therapies.
Less than half of cancer drugs approved via the FDA’s accelerated approval pathway between 2013 and 2017 showed clinical benefit in confirmatory trials in terms of overall survival or quality of life, according to the paper.
Merck and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.
Late-stage study results released Tuesday show YS Biopharma’s rabies vaccine candidate can induce twice the seroconversion rate at seven days versus a standard, globally marketed comparator.
A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
Plus, how the geopolitical tensions with China will affect U.S. biopharma