BioSpace News Archive

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
Business

Exsilio Launches With $82M to Tackle Gene Therapy Challenges in Novel Approach

Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.

June 25, 2024
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4 min read
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Ben Hargreaves
Drug Development

Novo Nordisk Continues Manufacturing Spending Spree With $4.1B Investment

Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina.

June 25, 2024
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2 min read
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Tristan Manalac
Deals

Grail to Begin Trading on Nasdaq as Illumina Completes Divestiture

After being spun off of sequencing giant Illumina, Grail on Tuesday is set to start trading on the Nasdaq Global Select Market following a years-long antitrust battle with regulators.

June 25, 2024
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2 min read
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Tristan Manalac
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

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