BioSpace News Archive

Fulcrum’s Clinical Hold Highlights Tough Road in Sickle Cell Space

The hits kept coming for the sickle cell disease space last week as the FDA placed a full clinical hold on Fulcrum Therapeutics’ Investigational New Drug application FTX-6058.

February 27, 2023

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2 min read

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Tristan Manalac

Business

Billy Dunn Steps Down from Post as FDA Neuroscience Head

Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.

February 27, 2023

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2 min read

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Heather McKenzie

Policy

Pay Transparency Backlash: the Harm of Reluctant Compliance

Senate Bill 1162, a law requiring employers to include pay ranges in all job advertisements, went into effect in California January 1. Here’s how employers are responding.

February 27, 2023

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4 min read

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Rosemary Scott

Drug Development

The ALS Puzzle Gets Two New Pieces: SYF2 and PIKFYVE

ALS is the 5,000-piece jigsaw puzzle of the therapeutic world. As the regulatory edges come together, new research pieces are also connecting.

February 27, 2023

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4 min read

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Heather McKenzie

Deals

Seagen has a New Suitor as Pfizer Talks Begin

Seagen and Pfizer are in early-stage talks over a potential acquisition that could exceed $30 billion.

February 27, 2023

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2 min read

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Tristan Manalac

Pictured: uniQure headquarters in Amsterdam

Business

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS

In its 2022 financial report Monday, uniQure provided updates on the progress of its Huntington’s disease and ALS programs.

February 27, 2023

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1 min read

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Kate Goodwin

Biotech Bay

Day One to Participate in the Cowen 43rd Annual Health Care Conference

Day One Biopharmaceuticals announced management will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7 at 9:10 a.m. ET.

February 27, 2023

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1 min read

Drug Development

Levation Pharma Initiates Phase I/II Clinical Trial of LEV102 for Acquired BlepharoptosisDouble Masked, Placebo Control Study at Three Prominent U.S. Sites

Levation Pharma Ltd., a pharmaceutical company focused on the development of new therapeutics for the ophthalmology and aesthetic space, received FDA clearance to initiate a Phase I/II of LEV102 for the treatment of Acquired Blepharoptosis in adults.

February 27, 2023

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2 min read

Biotech Bay

Apexigen Announces Review of Strategic Alternatives and Restructuring

Apexigen, Inc. today announced that it has engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic alternatives for the Company with the goal of maximizing stockholder value.

February 27, 2023

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5 min read

Pharm Country

OrthoVentions LLC Announces Partnership with HSS to Support Investments in Early-Stage Medical Technology

OrthoVentions LLC and the Hospital for Special Surgery announced they have entered into an agreement to support the development of technologies crafted by the premiere musculoskeletal surgeon group.

February 27, 2023

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2 min read