BioSpace News Archive

Business

BeiGene Inks Potential $1.3B Deal with Ensem for Early-Stage CDK2 Inhibitor

The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.

November 21, 2023
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2 min read
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Tristan Manalac
Business

Flagship Pioneering Launches First UK Biotech with $50M Investment

Quotient Therapeutics, co-located in Cambridge, Mass. and Cambridge, U.K., will receive $50 million over two years from Flagship to study somatic genomics with an eye to finding new targets for gene therapies.

November 21, 2023
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2 min read
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Connor Lynch
Treehill Partners’ Ali Pashazadeh on How to Improve Clinical Trial Design

After reviewing the outcomes of 1,200 clinical studies, the firm says it can help most biopharmas set their trials up for success while cutting costs in half.

November 21, 2023
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5 min read
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Nadia Bey
Business

First Rett Treatment Offers Hope to Morell Family

When twins Kenzie and Kaylie were diagnosed with Rett syndrome in 2016, there was no dedicated treatment for the neurodevelopmental disorder. That changed this year with the approval of Acadia Pharmaceuticals’ Daybue.

November 21, 2023
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4 min read
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Heather McKenzie
Policy

FDA Delays Decision on BMS, 2seventy bio’s Push for Earlier Line Abecma Treatment

The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.

November 21, 2023
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2 min read
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Tristan Manalac
Deals

Merck Drops Up to $610M on Neuro Disease-Focused Caraway Therapeutics

The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.

November 21, 2023
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1 min read
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Kate Goodwin
Drug Development

Mirati, Amgen, Lilly and More Race to the Front Line in KRAS-Mutated NSCLC

While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.

November 21, 2023
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6 min read
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Mollie Barnes
Policy

White House and Congress Propose AI Legislation as FDA Continues to Act as AI Regulatory Gatekeeper

Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.

November 21, 2023
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7 min read
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Lori Ellis
Drug Development

First ever CRISPR gene therapy approval: What happens next?

CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?

November 21, 2023
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1 min read
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Greg Slabodkin
Lone Star Bio

Alafair Biosciences Announces 12,000+ VersaWrap® Implants in Patients

Alafair Biosciences, Inc. announced that surgeons have implanted over 12,000 units of its flagship product, VersaWrap®, in patients since commercial launch.

November 21, 2023
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1 min read