BioSpace News Archive

Policy

FDA Action Alert: Argenx, Aldeyra, Intercept and Sarepta

The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.

June 15, 2023
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5 min read
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Tristan Manalac
Policy

Merck Secures Bridion Patent Protection Through January 2026

The company won a patent ruling from a New Jersey court, which extends protections from generic competition for its muscle relaxant reversal drug Bridion.

June 15, 2023
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2 min read
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Tristan Manalac
Drug Development

Verve Snags $60M in Lilly Support for Cardio Gene Editing

Eli Lilly has secured the rights to Verve Therapeutics’ gene editing approach, a “one-and-done” method that the companies hope will lower the cardiovascular risk factor lipoprotein(a).

June 15, 2023
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2 min read
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Lisa Munger
Child Dies, Two in Remission After Treatment with First Base-Edited Cell Therapy

Two children with relapsed T cell acute lymphoblastic leukemia were cleared of cancer while a third died from fungal infection, according to research published Wednesday in The New England Journal of Medicine.

June 15, 2023
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3 min read
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Kate Goodwin
Drug Development

FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold

Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.

June 15, 2023
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2 min read
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Tristan Manalac
Business

Astellas Bets Potential $1.9B on Cullgen’s Protein Degrader Tech

The Japanese biopharma is diving deeper into targeted protein degradation, paying $35 million upfront for access to Cullgen’s uSMITE platform.

June 15, 2023
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2 min read
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Heather McKenzie
Policy

Texas Orders Pfizer to Turn Over Meta Advertising Records

In a subpoena filed Monday, the state of Texas asked Pfizer to turn over all communications with Meta regarding the tech company’s advertising practices.

June 15, 2023
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2 min read
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Tristan Manalac
Policy

AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

The pharma company alleges that BeiGene’s Brukinsa patent, issued on Tuesday, infringes on its patent for Imbruvica to treat patients with slow-growing blood cancer.

June 15, 2023
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2 min read
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Alejandra Manjarrez
Drug Development

Anokion Announces Publication in The Lancet Gastroenterology & Hepatology Highlighting Safety and Preliminary Effects of KAN-101 in Celiac Disease in its ACeD Phase 1 Clinical Trial

Anokion SA announced that The Lancet Gastroenterology & Hepatology has published clinical data on KAN-101 from the Phase 1 ACeD Trial, which support the favorable safety of KAN-101 and signals of dose-dependent reactivity to gluten and induction of immune tolerance in patients with celiac disease.

June 15, 2023
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3 min read
Business

Foundation Medicine Announces Leadership Appointments - June 15, 2023

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, announced organizational changes to the executive leadership team to position the company for continued growth and usher in the next era of cancer care.

June 15, 2023
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4 min read