BioSpace News Archive

Drug Development

Boehringer, Zealand Heat Up MASH Race With Strong Phase II Data

The companies announced Friday that their candidate survodutide, which is licensed to Boehringer Ingelheim from Zealand Pharma, improved fibrosis in more than 50% of treated patients with metabolic dysfunction-associated steatohepatitis.

June 7, 2024
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2 min read
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Tristan Manalac
Deals

Vanda Gets $466M Unsolicited Offer from Cycle Amid Ongoing Row with FDA

After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.

June 7, 2024
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2 min read
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Tristan Manalac
Drug Development

Biomea’s Stock Nosedives More Than 60% as FDA Puts Clinical Hold on Diabetes Candidate

Biomea Fusion’s early-stage investigational diabetes treatment BMF-291 has been slapped with a full FDA clinical hold on its Phase I/II trials due to concerns over liver toxicity.

June 7, 2024
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1 min read
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Tyler Patchen
Drug Development

MASH Clash Between Lilly and Boehringer-Zealand Takes Center Stage at EASL24

Both Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma have mid-stage data readouts this week, fueling the race in metabolic dysfunction-associated steatohepatitis.

June 7, 2024
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3 min read
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Greg Slabodkin
Drug Development

AbbVie Sees Early ROI on $10B Immunogen Buy in Phase II Ovarian Cancer Win

AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.

June 7, 2024
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2 min read
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Tristan Manalac
FDA

FDA Approves Geron’s First-in-Class Telomerase Inhibitor for Blood Disorder

Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.

June 7, 2024
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2 min read
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Kate Goodwin
Policy

FDA Raises Concerns About Lilly’s Donanemab Alzheimer’s Candidate Ahead of Adcomm

In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.

June 7, 2024
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2 min read
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Tristan Manalac
Policy

DePuy Synthes Receives 510(k) FDA Clearance of the VELYS™ Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures

Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510 FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty.

June 7, 2024
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9 min read
Pharm Country

Innovation in Pharmacogenomic Testing for Over a Decade

Principle Diagnostics Laboratory, a leader in Pharmacogenomic testing, proudly celebrates a decade of pioneering advancements in personalized medicine.

June 7, 2024
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3 min read
FDA

ChromaDex Receives Exclusive U.S. FDA Orphan Drug Designation (ODD) and Rare Pediatric (RPD) Disease Designation for Nicotinamide Riboside Chloride (NRC) for the Treatment of Ataxia Telangiectasia (AT)

ChromaDex Corp. today announced that the U.S. Food & Drug Administration (FDA) granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation for NRC, the company’s product candidate for the treatment of Ataxia Telangiectasia (AT).

June 7, 2024
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8 min read