BioSpace News Archive

Drug Development

Novo Nordisk’s Hemophilia Hopeful Hits FDA Roadblock, Company Cuts Wegovy Supply

During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.

May 5, 2023
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2 min read
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Tristan Manalac
Business

Regeneron Diversifies Portfolio as Eylea Revenue Takes a Hit

As competition eats away at profits for the wet age-related macular degeneration drug, Regeneron is diversifying its portfolio and pumping more money into research and development.

May 5, 2023
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2 min read
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Tristan Manalac
AstraZeneca, Pfizer Top 2023 Pharma List for Invention and Innovation

Idea Pharma’s annual index reveals key drivers and metrics for large companies. AstraZeneca and Pfizer remain in the top positions this year for invention and innovation, respectively.

May 5, 2023
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3 min read
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Kate Goodwin
Drug Development

Biogen, Novartis, Sanofi Cull Candidates in Q1 Pipeline Reprioritizations

The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.

May 5, 2023
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3 min read
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Nick Paul Taylor
Drug Development

Biopharma Bets Big on Antibody-Drug Conjugates

After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.

May 5, 2023
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5 min read
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Natalia Mesa
Policy

FDA Action Alert: Sarepta, Protalix, Otsuka/Lundbeck and More

The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.

May 5, 2023
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6 min read
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Tristan Manalac
Drug Development

FDA Guidance May Bolster Confidence in Decentralized Clinical Trials

The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.

May 5, 2023
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3 min read
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Natalia Mesa
Policy

Norlase Receives FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser

Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, announced it has received both FDA 510 clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator.

May 5, 2023
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3 min read
Business

Owens & Minor Reports First Quarter 2023 Financial Results

Owens & Minor, Inc. reported financial results for the first quarter ended March 31, 2023.

May 5, 2023
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11 min read
Drug Development

Targeting RAS: Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer

Golden Biotechnology Corp. announces the release of positive interim results from its Phase II clinical trial of Antroquinonol in combination with the standard of care nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer.

May 5, 2023
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5 min read