BioSpace News Archive

Drug Development

AbbVie, Genmab Bi-Specific Lymphoma Data Tee Up Potential Challenge to Roche Drug

Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.

June 29, 2023
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2 min read
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Nick Paul Taylor
FDA

FDA Approves First Cell Therapy for Type 1 Diabetes

Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.

June 29, 2023
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2 min read
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Heather McKenzie
Policy

FDA Centers Seek Regulatory Harmonization to Ease Industry Burden

The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.

June 29, 2023
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5 min read
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Ana Mulero
Alkermes Shareholders Reject All of Sarissa’s Nominees for Its Board

The biopharma company instead chose to re-elect its existing board members.

June 29, 2023
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2 min read
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Lucy Miguel
Drug Development

Foghorn Abandons Uveal Melanoma Program after Subpar Phase I Results

The company halted studies of the treatment for a rare, advanced form of eye cancer after clinical results showed just one response in 47 patients.

June 29, 2023
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2 min read
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Connor Lynch
Deals

Lilly to Buy Diabetes Cell Therapy Partner Sigilon for Just Over $300M

Eli Lilly announced Thursday it will acquire former collaborative partner Sigilon Therapeutics to deepen its diabetic foothold with a potentially functional cure for Type 1.

June 29, 2023
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2 min read
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Kate Goodwin
Drug Development

BioXcel’s Positive Alzheimer’s Agitation Data Overshadowed by Principal Investigator Fabrications

The company Thursday reported positive topline results for a Phase III trial of its Alzheimer’s-related agitation treatment, while also disclosing improprieties by a principal investigator.

June 29, 2023
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2 min read
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David Adam
China Medical System Included in the First ‘Sustainability Yearbook (China)’ of S&P Global

Recently, S&P Global, the world’s leading corporate sustainability assessment institution, has officially released the first “Sustainability Yearbook 2023 ".

June 29, 2023
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3 min read
Drug Development

Alumis Announces Expansion of Allosteric TYK2 Inhibitor, ESK-001, Phase 2 Program into Systemic Lupus Erythematosus (SLE) and Uveitis

Alumis Inc. today announced that patient dosing has commenced in LUMUS, a Phase 2b clinical trial of ESK-001 for the treatment of patients with systemic lupus erythematosus (SLE) and in OPTYK-1, a proof-of-concept Phase 2 clinical trial in uveitis.

June 29, 2023
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6 min read
Drug Development

Urica Therapeutics Announces Topline Data from the Phase 1 Clinical Trial Evaluating Dotinurad in Healthy Volunteers in the United States

Urica Therapeutics, Inc. today announced topline data from the Phase 1 clinical trial evaluating dotinurad in healthy volunteers in the United States (“U.S.”).

June 29, 2023
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7 min read