BioSpace News Archive

Drug Development

AstraZeneca’s Imfinzi Fails Phase III NSCLC Trial, Aces Late-Stage Bladder Cancer Study

AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.

June 25, 2024
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2 min read
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Tristan Manalac
Drug Development

J&J’s Blockbuster Tremfya Flops in Phase II Giant Cell Arteritis Trial

Following success in several indications including ulcerative colitis, J&J’s blockbuster drug Tremfya failed to meet a mid-stage study’s primary endpoint in treating giant cell arteritis.

June 25, 2024
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2 min read
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Tyler Patchen
Career Advice

New Team, Same Company: How to Transition to Your New Role

When moving to a new role at the same company, it’s important to create a transition plan, understand your responsibilities and expectations and get to know your new team.

June 25, 2024
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5 min read
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Angela Gabriel
Sarepta’s Big DMD Approval, Alnylam’s Clinical Win and ADA Highlights

This week, we discuss the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, Alnylam’s high stakes ATTR-CM win and highlights from ADA.

June 25, 2024
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1 min read
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Greg Slabodkin, Heather McKenzie, Tyler Patchen
Career Advice

Leadership Lab: 3 Strategies for an Executive’s Discreet Job Search

It’s important to maintain anonymity when seeking your next executive role, as your departure could impact other employees and the organization.

June 25, 2024
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4 min read
FDA

After Full Approval, Sarepta Lays Out Its Next Moves

After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.

June 25, 2024
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3 min read
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Tyler Patchen
Policy

FDA Action Alert: Arcutis, Orexo, Phantom and More

The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.

June 25, 2024
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7 min read
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Tristan Manalac
Drug Development

Merck KGaA Fails Phase III Study in Head and Neck Cancer, Scraps Trials

Merck KGaA’s drug candidate xevinapant in a late-stage trial was unable to significantly improve event-free survival in patients with locally advanced head and neck cancer.

June 25, 2024
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2 min read
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Tristan Manalac
Drug Development

Verona Gears Up for First Novel COPD Approval in Over a Decade

If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.

June 25, 2024
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4 min read
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Aayushi Pratap
Policy

FDA Again Hits AbbVie Parkinson’s Treatment With Complete Response Letter

Citing issues with a third-party manufacturer, the FDA has issued another Complete Response Letter to AbbVie rejecting its New Drug Application for ABBV-951, a proposed treatment for motor fluctuations in adults with advanced Parkinson’s disease.

June 25, 2024
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2 min read
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Kate Goodwin