BioSpace News Archive

Policy

FDA Calls for Boxed Warnings on CAR-T Therapies Regarding Secondary Cancer Risks

Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.

January 23, 2024
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2 min read
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Tristan Manalac
Business

Roche Ends Longstanding Collaboration with AC Immune, Hands Back Assets

After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech.

January 23, 2024
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2 min read
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Tyler Patchen
Business

J&J Beats Q4 Expectations, Reports $21.4B in Revenue as Faces Patent Cliff

Johnson & Johnson exceeded fourth-quarter earnings estimates, reporting nearly $21.4 billion in revenue, as its pharma business faces a patent cliff with Stelara competition entering the market.

January 23, 2024
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2 min read
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Kate Goodwin
Opinion: Can Emerging Markets Help Fight the Antimicrobial Crisis?

There is a significant mismatch between the need for new antimicrobials and the traditional pharmaceutical business model.

January 23, 2024
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4 min read
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Cem Zorlular
What’s Next for CRISPR?

Following the December and January approvals of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, analysts believe another CRISPR approval is unlikely in the near future.

January 23, 2024
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5 min read
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Kate Goodwin
PhRMA, BIO Push Back Against Rare String of Setbacks

The two biopharmaceutical industry organizations entered Medicare price negotiations after the loss of several prominent members and executives.

January 23, 2024
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4 min read
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Neil Versel
Deals

Grab an umbrella, it’s raining ⁠IPOs⁠!

This week, Lori, Greg and Tyler discuss the first ⁠surge of IPO activity⁠ this year plus gene therapy pricing,

January 23, 2024
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1 min read
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Lori Ellis
Business

Coherus Offloads Lucentis Biosimilar to Sandoz for $170M in Pivot to Oncology

Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.

January 23, 2024
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2 min read
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Tristan Manalac
The Rising Tide of the Biofilms Market: Wound Care and Beyond

There is growing investment in fighting bacterial growth in a wide range of settings, with the market estimated to reach more than $3 billion within eight years.

January 23, 2024
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4 min read
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Karen Fischer
Drug Development

Novo Nordisk Inks Potential $255M Deal with EraCal, Targets Another Obesity Asset

The Danish pharma has signed a collaboration and license agreement with Swiss biotech EraCal Therapeutics to access a novel candidate for controlling appetite and body weight.

January 23, 2024
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2 min read
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Tyler Patchen