BioSpace News Archive

Drug Development

Deep Dive: Psychedelics for Mental Health

In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD.

June 5, 2024
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4 min read
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Heather McKenzie
Policy

FDA Adcomm Votes Against Lykos’ MDMA-Assisted PTSD Therapy

An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials.

June 5, 2024
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2 min read
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Tristan Manalac
Policy

Lilly’s Zepbound Wins NICE Backing for Obese Patients With Very High BMI

The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity.

June 5, 2024
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2 min read
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Tristan Manalac
Biotech Beach

The ABCs of Biopharma This Week: ASCO, BIO and Cancer

The biggest conferences of the year dominated news this week: the American Society of Clinical Oncology annual meeting and the BIO International Convention.

June 5, 2024
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1 min read
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Greg Slabodkin, Heather McKenzie, Tyler Patchen
Drug Development

Vir Seeks to Challenge Gilead With Phase II Hepatitis Delta Data

Vir Biotechnology reported Wednesday that its monoclonal antibody tobevibart, as a monotherapy and in combination with Alynylam-partnered elebsiran, achieved high rates of virologic response at week 24 in patients with chronic hepatitis delta.

June 5, 2024
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1 min read
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Kate Goodwin
Drug Development

Gilead, Ipsen Tout Phase III Primary Biliary Cholangitis Data as PDUFA Dates Loom

Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.

June 5, 2024
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2 min read
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Tyler Patchen
Drug Development

Viking Builds Case for NASH Hopeful With Histological Data

Viking Therapeutics’ nonalcoholic steatohepatitis candidate VK2809 significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy.

June 5, 2024
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2 min read
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Tristan Manalac
Drug Development

Lilly’s Tirzepatide Shows Positive Phase II NASH Data, Tees Up Potential Expansion

More than 50% of nonalcoholic steatohepatitis patients treated with Eli Lilly’s tirzepatide saw at least a one-stage improvement in fibrosis, according to the pharma’s latest mid-stage readout.

June 5, 2024
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2 min read
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Tristan Manalac
Employer Resources

Embracing Inclusivity: How Biopharmas Connect With LGBTQ+ Employees

There are multiple ways biopharmas create inclusive workplaces for LGBTQ+ employees, and they go beyond employee resource groups and benefits.

June 5, 2024
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6 min read
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Angela Gabriel
BioSpace x DIA: Robust Integrated Regulatory Strategies

How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology? Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.

June 5, 2024
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1 min read