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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
139 Results
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FDA
EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)
Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
June 26, 2024
·
17 min read
Policy
Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer
The U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologics License Application seeking accelerated approval of Daiichi Sankyo and Merck’s patritumab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies.
June 26, 2024
·
12 min read
Drug Development
Wave Clears Phase Ib/IIa Study in Huntington’s Disease, Eyes Accelerated Approval
After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.
June 26, 2024
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2 min read
·
Tristan Manalac
Business
Lilly Teams With OpenAI to Tackle Threat of Drug-Resistant Bacteria
Following in the footsteps of Sanofi and Moderna, Eli Lilly on Tuesday inked a collaboration agreement with OpenAI to develop novel antimicrobial agents against drug-resistant pathogens.
June 26, 2024
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2 min read
·
Tristan Manalac
Policy
Teva Pays $750M to Resolve Israeli Tax Issues Going Back More Than a Decade
Teva Pharmaceuticals has settled years of tax litigation with the Israel Tax Authority for $750 million, which the company will pay in installments starting in 2024 to 2029.
June 26, 2024
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2 min read
·
Tristan Manalac
Drug Development
Lyell Reports Patient Death in Early-Stage CAR T Trial, Shows Otherwise Strong Response Rate
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
June 26, 2024
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2 min read
·
Tristan Manalac
Business
Curie.Bio Adds $380M Series A Fund to Move Biotech Startups to Clinic
The biotech incubator said Wednesday the majority of the fund will be for clinical proof-of-concept studies, bringing the total funds raised by Curie.Bio to nearly $1 billion.
June 26, 2024
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1 min read
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Kate Goodwin
Drug Development
Zealand to Raise $1B in Public Offering to Fund Obesity Candidates
Zealand Pharma is looking to build on last week’s positive Phase Ib trial results by raising around $1 billion in a public offering, with the proceeds being used to advance its obesity candidates.
June 26, 2024
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1 min read
·
Tyler Patchen
Job Trends
5 Top Companies Hiring in the Washington, D.C., Area
Looking for a biopharma job in or near Washington, D.C.? Check out these five top companies hiring life sciences professionals like you.
June 26, 2024
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1 min read
·
Angela Gabriel
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