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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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Stada CEO Confirms Buyout Rumors, Sale Could Potentially Fetch $11B
Amid strong performance in the first half of 2023, Stada Arzneimittel’s private equity owners are considering a potential sale, though there are still no definite plans, according to CEO Peter Goldschmidt.
August 16, 2023
·
2 min read
·
Tristan Manalac
Drug Development
Seagen Touts Phase III Data for Breast Cancer Combo Therapy
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
August 16, 2023
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2 min read
·
Connor Lynch
Policy
Bluebird’s Lovo-Cel Gene Therapy for SCD Will Not Face FDA Adcomm
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
August 16, 2023
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2 min read
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Tristan Manalac
FDA
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
August 16, 2023
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2 min read
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Tristan Manalac
Business
Bioretec unveils its revitalized Scientific Advisory Board (SAB), focusing on driving innovations in orthopedic implants
Bioretec Ltd, a pioneering company dedicated to advancing orthopedic biodegradable implants, has refined and expanded its esteemed Scientific Advisory Board.
August 16, 2023
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6 min read
Drug Development
IDEAYA Announces First-Patient-In for Company-Sponsored Phase 2 Clinical Trial Evaluating Darovasertib in (Neo)Adjuvant Uveal Melanoma
IDEAYA Biosciences, Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the achievement of First-Patient-In for the company-sponsored Phase 2 clinical trial evaluating darovasertib as neoadjuvant and adjuvant therapy in primary uveal melanoma patients.
August 16, 2023
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6 min read
Pharm Country
FesariusTherapeutics receives NIH Commercial Readiness grant for DermiSphere™ dermal regeneration template in preparation for market release
FesariusTherapeutics, Inc. today announced they have been awarded an $800,000 SBIR CRP grant to advance the development of their novel DermiSphere™ dermal regenerative template to treat full thickness skin loss.
August 16, 2023
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3 min read
Genetown
bluebird bio Confirms That FDA Has Communicated That Advisory Committee Meeting Will Not Be Scheduled for lovo-cel Gene Therapy for Sickle Cell Disease
bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel).
August 16, 2023
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8 min read
Business
Silence Therapeutics Reports Second Quarter 2023 Results
Silence Therapeutics plc today reported its financial results for the second quarter ended June 30, 2023 and reviewed recent business highlights.
August 16, 2023
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9 min read
Business
Covalon Announces Third Quarter Fiscal 2023 Results
Covalon Technologies Ltd. (the “Company” or “Covalon”) (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, today announced its third quarter fiscal 2023 results.
August 16, 2023
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18 min read
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