BioSpace News Archive

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
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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
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
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
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Connor Lynch
Policy

Biophytis Announces Next Regulatory Steps in Europe and the United States for its COVA Project

Biophytis SA announced that it has received feedback from the European Medicines Agency and the Food and Drug Administration enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos for severe forms of Covid-19.

August 16, 2023
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4 min read
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
Tetra Pharm Technologies inaugurates new R&D, manufacturing and production facility

The Danish biotech company, Tetra Pharm Technologies, announces completion of its new purpose-built headquarters facility to support long-term growth plans.

August 16, 2023
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2 min read
Promore Pharma Engages Erik Penser Bank as Liquidity Provider

Promore Pharma AB announced that the company has entered into an agreement with Erik Penser Bank to act as liquidity provider for the Promore Pharma share starting 21 August 2023.

August 16, 2023
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1 min read
Deals

Eyenovia Acquires U.S. Commercial Rights to APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension, 0.05%) from Formosa Pharmaceuticals

Eyenovia, Inc. announced that it has entered into an agreement with Taiwan-based Formosa Pharmaceuticals whereby Eyenovia has acquired the exclusive U.S. Food and Drug Administration,

August 16, 2023
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6 min read
Formosa Pharmaceuticals Announces Licensing Agreement with Eyenovia, Inc., for the Commercialization of APP13007 for the Treatment of Inflammation and Pain Following Ocular Surgery

Taiwan-based Formosa Pharmaceuticals announced that the company has entered into a licensing agreement with Eyenovia, Inc., whereby Eyenovia obtains exclusive U.S. rights for the commercialization of APP13007 for the treatment of inflammation and pain following ocular surgery.

August 16, 2023
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3 min read