BioSpace News Archive

FDA

Sandoz Nabs FDA Approvals for First Two Biosimilars for Amgen’s Denosumab

Sandoz’s two interchangeable biosimilars, Jubbonti and Xgeva, are poised to challenge Amgen’s blockbuster bone drug denosumab. However, no launch details were announced Tuesday due to ongoing patent litigation.

March 6, 2024
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2 min read
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Tristan Manalac
Policy

Regulatory Pathway Widening for Cardiac Gene Therapy Hopefuls

Separate challenges exist for companies developing gene therapies for rare and common cardiovascular conditions, experts told BioSpace.

March 6, 2024
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5 min read
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Kate Goodwin
Drug Development

ITF Gears Up for FDA Decision in Expanding DMD Market

The recently launched company shared two posters at the Muscular Dystrophy Association’s annual conference this week ahead of a March 21 PDUFA date.

March 6, 2024
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5 min read
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Heather McKenzie
ME Therapeutics Announces Closing of Non-Brokered Private Placement

ME Therapeutics Holdings Inc. announces the closing of its previously announced non-brokered private placement financing (the “Offering”) and has issued 1,555,000 units (each, a “Unit”) at a price of $1.00 per Unit raising gross proceeds of $1,555,000.

March 6, 2024
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4 min read
Alumis Raises $259M Series C, Challenges BMS and Takeda for Autoimmune Markets

The California-based biotech will use the Series C funding to move its TYK2 inhibitor into Phase III in plaque psoriasis this year in a potential challenge to Bristol Myers Squibb and Takeda.

March 6, 2024
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2 min read
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Nick Paul Taylor
Drug Development

Sionna Closes $182M Series C in Potential Cystic Fibrosis Showdown with Vertex

Sionna Therapeutics on Wednesday announced it raised another round of funding as the company looks to challenge Vertex Pharmaceuticals’ dominant cystic fibrosis business.

March 6, 2024
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2 min read
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Tyler Patchen
Career Advice

How to Prepare a Presentation for a Biopharma Job Interview

Presentations are standard requirements in the hiring process for some biopharma positions. Here’s how to approach them.

March 6, 2024
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2 min read
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Nadia Bey
WHO Warns of Growing Resistance in Individuals to GSK, ViiV’s HIV Drug Tivicay

The World Health Organization has detected signals of growing HIV resistance to GSK and ViiV Healthcare’s Tivicay, which it says must be minimized as part of the broader global response to antimicrobial resistance.

March 6, 2024
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2 min read
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Tristan Manalac
Drug Development

Alnylam’s Zilebesiran Shows Positive Phase II Results in Reducing Blood Pressure

A mid-stage study of Alnylam Therapeutics’ experimental RNAi-based drug to treat hypertension met its primary endpoint.

March 6, 2024
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2 min read
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Tyler Patchen
Policy

UK’s NICE Rejects AstraZeneca, Daiichi Sankyo’s Enhertu for NHS Use

Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.

March 6, 2024
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2 min read
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Tristan Manalac