BioSpace News Archive

Drug Development

AbbVie Gets Phase II NSCLC Win for ADC, Looks to Accelerated Approval

The company’s investigational c-Met protein directed antibody-drug conjugate showed a “compelling” overall response rate in patients with previously treated non-small cell lung cancer.

December 1, 2023
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2 min read
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Tyler Patchen
Drug Development

ADC and GLP-1 Rocket Ride Continues as 2023 Comes to Close

AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.

December 1, 2023
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3 min read
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Greg Slabodkin
Drug Development

Altimmune Joins Weight-Loss Race with Phase II Win, Stock Jumps on News

Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.

December 1, 2023
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2 min read
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Tristan Manalac
Drug Development

Astellas Touts Phase III Data for Menopause Drug, Eyes European Reimbursement

The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.

December 1, 2023
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2 min read
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Tyler Patchen
GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status

CEO Emma Walmsley projects that the British biopharma’s Arexvy sales will exceed £1 billion in its first year on the market, leaving Pfizer’s Abrysvo respiratory syncytial virus vaccine far behind in the race.

December 1, 2023
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2 min read
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Tristan Manalac
Drug Development

AstraZeneca Axes Two Phase III Hyperkalemia Trials for Lokelma

Citing slow enrollment and low clinical rates, the late-stage “evidence trials” are being discontinued. AstraZeneca said there are no safety concerns and no impact on Lokelma’s current approved indication.

December 1, 2023
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1 min read
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Kate Goodwin
Drug Development

FDA Action Alert: Vertex/CRISPR, Arcutis and Optinose

This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.

December 1, 2023
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4 min read
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Tristan Manalac
Drug Development

Pfizer Nixes Twice-Daily Oral GLP-1 Candidate After High Rates of Side Effects

While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea.

December 1, 2023
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2 min read
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Tyler Patchen
Drug Development

Moving RNA Therapeutics Beyond the Liver

From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.

December 1, 2023
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7 min read
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Heather McKenzie
Business

GC Biopharma establishes mRNA production facility in Hwasun, Korea

GC Biopharma, a South Korean biopharmaceutical company, announced on November 30th that it has completed the construction mRNA production facility in its own vaccine production plant in Hwasun, Jeollanam-do, Korea, and will soon start the operation.

December 1, 2023
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2 min read