BioSpace News Archive

MassBio

MassBio, a not-for-profit organization that represents and provides services and support for the Massachusetts life sciences industry, is the nation’s oldest biotechnology trade association. Founded in 1985, MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.
Drug Development

ICER Doubles Down on Critique of Lykos’ MDMA Therapy, Cites Data Concerns

The Institute for Clinical and Economic Review has again flagged “substantial concerns” with Lykos Therapeutics’ data for its MDMA-based therapy for post-traumatic stress disorder and propensity for bias.

June 28, 2024
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2 min read
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Tristan Manalac
Deals

AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff

AbbVie on Thursday announced it has acquired Celsius Therapeutics to expand its immunology portfolio with a first-in-class TREM1 inhibitor CEL383, following other big players looking to cash in on the hot immuno market.

June 28, 2024
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2 min read
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Tristan Manalac
Policy

FDA Rejects Rocket’s Gene Therapy, Cites Need for Additional CMC Info

Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.

June 28, 2024
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2 min read
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Tyler Patchen
FDA

FDA Needs to Step Up As Use of Third-Party Manufacturers Leads to Rejections

AbbVie and Merck/Daiichi Sankyo were hit this week with Complete Response Letters from the FDA, which rejected their respective drugs due to manufacturing issues.

June 28, 2024
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3 min read
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Greg Slabodkin
Deals

Alumis Pushes Through With Smaller IPO, Looks to Raise $250M for Immuno Candidate

Alumis is debuting in an initial public offering Friday on the Nasdaq, though the $250 million IPO is less than its initial targeted raise of $274 million just days ago.

June 28, 2024
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2 min read
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Tristan Manalac
Drug Development

Gilead’s Trodelvy Stumbles in Late-Stage Trials But Remains Prized Cancer Asset

Gilead Sciences’ blockbuster antibody-drug conjugate Trodelvy has encountered some clinical speed bumps in 2024 in bladder and lung cancer. Still, analysts remain bullish on its prospects in the oncology space.

June 28, 2024
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4 min read
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Tyler Patchen
Business

Illumina Reports $1.47B ‘Goodwill’ Impairment Charge After Grail Spinoff

Following the recently completed spinoff of cancer detection company Grail, sequencing giant Illumina said Thursday it expects to absorb a $1.47 billion goodwill impairment charge.

June 28, 2024
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2 min read
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Tristan Manalac
Drug Development

Beyond GLP-1s: The Next Obesity Treatments

Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues.

June 28, 2024
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6 min read
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Heather McKenzie
Deals

Alumis Announces Pricing of Initial Public Offering - June 28, 2024

Alumis Inc. announced the pricing of its initial public offering of 13,125,000 shares of common stock at an initial public offering price of $16.00 per share.

June 28, 2024
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6 min read