BioSpace News Archive

Drug Development

Merck Ready to Submit Belsomra to FDA for Alzheimer’s Insomnia

The company announced today that it had positive results in a Phase III clinical trial evaluating the drug for insomnia in patients with mild-to-moderate Alzheimer’s disease dementia.

May 7, 2019
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2 min read
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Mark Terry
Drug Development

AstraZeneca Halts Phase III CLL Trial Early After Primary Endpoints Are Met

Full data will be shared at a later conference, but the study marked the first time a BTK inhibitor showed benefit as a monotherapy in CLL.

May 7, 2019
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2 min read
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Alex Keown
Business

Interview: As Gene and Cell Therapies Grow, Reimbursement Model Needs to Change

Although the advent of cell and gene therapies is revolutionizing medicine, it is arguable that the therapies that have been approved to date in this area aren’t living up to expectations.

May 7, 2019
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6 min read
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Mark Terry
FDA

FDA Had Questions About Novartis’ Data Practices During Mayzent MS Approval

On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.

May 7, 2019
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3 min read
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Mark Terry
Deals

BioSpace’s List of May 2019 Life Science IPOs

A summary of IPOs from companies in the biotech and pharma world since May 1, 2019.

May 7, 2019
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1 min read
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Editorial Staff
Drug Development

Playing Catch-up, Genentech’s Oral Drug for SMA Shows Promise in Clinical Trials

Genentech, a Roche company, presented data from its FIREFISH clinical trial of risdiplam in Type 1 spinal muscular atrophy (SMA) at the American Academy of Neurology Annual Meeting.

May 7, 2019
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3 min read
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Mark Terry
Policy

Will Government Incentives Help Boost Antibiotic Development? Some Pharma Companies Think So

Over and over there are reports about the increasing rise of antibiotic resistant bugs. Even as the number of resistant bacteria increases, the number of companies developing new types of antibiotics is decreasing.

May 7, 2019
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3 min read
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Alex Keown
Drug Development

GW’s Cannabidiol Epidiolex Hits in Phase III Trial for Rare Form of Epilepsy

GW Pharmaceuticals anticipates filing a supplemental New Drug Application with the FDA for the new indication later this year.

May 7, 2019
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2 min read
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Alex Keown
Business

Verve Therapeutics Explodes out of Stealth Mode to Focus on Gene Therapies for Cardiovascular Disease

Verve Therapeutics launched with a $58.5 million Series A financing round. It was led by GV (formerly Google Ventures).

May 7, 2019
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3 min read
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Mark Terry
Business

Exclusive: MasterControl Software Provides Efficiency, Transparency for Life Science Companies

There are several lessons that companies and investors can learn from the collapse of Theranos, and one of the key takeaways is in the area of transparency.

May 7, 2019
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3 min read
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Alex Keown