BioSpace News Archive

Policy

FDA Adcomm Backs Neuroblastoma Treatment, Even Without RCT Data

Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.

October 5, 2023
·
2 min read
·
Tristan Manalac
Employer Resources

Report: Recruitment Market Update, 2023 Q3

This labor market report examines Q3 life science job market trends and the recruitment outlook for Q4 and beyond.

October 5, 2023
·
1 min read
·
BioSpace Insights
FDA

6 Drugs Approved Despite Failed Trials or Minimal Data

Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.

October 5, 2023
·
6 min read
·
Heather McKenzie
Deals

Kyowa Kirin Buys Orchard for Potential $478M as FDA Decision Looms

The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.

October 5, 2023
·
2 min read
·
Kate Goodwin
Drug Development

Small Percentage of Adults with Early Alzheimer’s Eligible for Leqembi: Study

Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.

October 5, 2023
·
3 min read
·
Katie Brown
Policy

FDA Puts Innate’s Lymphoma Trials on Partial Hold After Patient Death

Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.

October 5, 2023
·
2 min read
·
Tristan Manalac
Drug Development

J&J’s Spravato Bests Quetiapine in Phase III Head-to-Head Depression Study

Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.

October 5, 2023
·
2 min read
·
Tristan Manalac
GLP-1 Agonists, Like Ozempic and Wegovy, Have Risk of Gut Issues: Study

The class of drugs, which includes Novo Nordisk’s Ozempic and Wegovy, are associated with the risk of gastrointestinal adverse events when used for weight loss, finds a study published Thursday in JAMA.

October 5, 2023
·
3 min read
·
Connor Lynch
Job Trends

2023 Q3 Job Market Report: Tension While Recruitment Slows

In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.

October 5, 2023
·
1 min read
·
Chantal Dresner
BioUtah’s 2023 Utah Life Sciences Summit Presented by Mayer Brown Coming November 9 to Salt Lake City

BioUtah, Utah’s trade association dedicated to the life sciences community, today announced its 2023 Utah Life Sciences Summit presented by Mayer Brown

October 5, 2023
·
1 min read