BioSpace News Archive

Drug Development

FDA Adcomm Votes to Reject Merck’s Chronic Cough Drug

In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.

November 17, 2023
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3 min read
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Tyler Patchen and Heather McKenzie
Drug Development

Lilly Invests $2.5B in German Plant Amid Explosive Demand for Obesity Drugs

To help cope with the high demand for weight-loss treatments, Eli Lilly is investing $2.5 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management.

November 17, 2023
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2 min read
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Tristan Manalac
FDA

AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

The company’s Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

November 17, 2023
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2 min read
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Tyler Patchen
Drug Development

Deep Dive: How Four Companies are Leveraging AI in Drug Development

In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.

November 17, 2023
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4 min read
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Heather McKenzie
Drug Development

AbbVie’s Migraine Drug Ubrelvy Scores Victory in Phase III Study

When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.

November 17, 2023
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2 min read
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Tristan Manalac
Policy

Welcome to the Brave New World of CRISPR Gene Editing

The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.

November 17, 2023
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3 min read
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Greg Slabodkin
FDA

Merck Expands Keytruda’s Label as a First-Line Option for Gastric Cancer

The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

November 17, 2023
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2 min read
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Tristan Manalac
FDA

Pfizer, Astellas’ Xtandi Gets FDA Approval for Earlier Prostate Cancer Treatment

Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.

November 17, 2023
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2 min read
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Kate Goodwin
Business

Verona Pharma’s President and CEO David Zaccardelli Wins Executive of the Year SCRIP Award

Verona Pharma plc, announces its President and CEO, David Zaccardelli, has won ‘Executive of the Year 2023’ at the SCRIP Awards in recognition of his exemplary leadership.

November 17, 2023
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2 min read
Business

RaySearch Laboratories: Interim report January 1 - September 30, 2023

CEO Johan Löf and interim CFO Annika Blondeau Henriksson will present RaySearch’s interim report for January - September 2023 at a webcast to be held in English on Friday, November 17, 2023 at 10:00-10:30 a.m. CET.

November 17, 2023
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2 min read