BioSpace News Archive

FDA

J&J Wins Full FDA Approval for Rybrevant, Chemo Combo in NSCLC

Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.

March 4, 2024
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2 min read
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Tristan Manalac
Policy

IRA Drives Pfizer’s Decision to Focus on Biologics, Not Small Molecules

Pfizer’s oncology strategy to build up its biologics portfolio and dramatically reduce small molecules was influenced by the Inflation Reduction Act’s drug price negotiation provisions.

March 4, 2024
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4 min read
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Greg Slabodkin
Drug Development

Exosome Therapeutics Are Paving a Path to Clinical Readiness

Exosomes show potential to treat myriad conditions, including cancer and inflammation, but experts are divided on whether the therapies are ready for the limelight.

March 4, 2024
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6 min read
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Sruthi S. Balakrishnan
Drug Development

Akero Bounces Back in MASH, Posts Positive Mid-Stage Fibrosis Data

New 96-week data show Akero Therapeutics’ efruxifermin can improve fibrosis by at least one stage without metabolic dysfunction-associated steatohepatitis worsening in more patients versus placebo.

March 4, 2024
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2 min read
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Tristan Manalac
Drug Development

ALS Treatment Landscape ‘Primed’ with Over 100 Candidates: GlobalData

Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.

March 4, 2024
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2 min read
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Tristan Manalac
Drug Development

Bayer Pays $310M to BridgeBio for ATTR-CM Treatment in Europe

As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.

March 4, 2024
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2 min read
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Tyler Patchen
Medigene AG Expands Patent Portfolio in Japan for iM-TCR Technology to Directly Control TCR-T Safety and Efficacy, In Vivo

Medigene AG announced that the Company has been issued a patent by the Japan Patent Office protecting its inducible Medigene T cell receptor, a control mechanism to regulate efficacy and safety of its T cell receptor engineered T cell therapies.

March 4, 2024
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4 min read
BioNxt Reports Completion of ODF Cladribine PK Study - March 04, 2024

BioNxt Solutions Inc. is pleased to report that the comparative pharmacokinetic study for its oral dissolvable film based proprietary Cladribine product for the treatment of Multiple Sclerosis has been completed.

March 4, 2024
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3 min read
Policy

Results from the Clinical Trial of Qilu Pharmaceutical’s Novel Anticancer Agent Iparomlimab and Tuvonralimab (QL1706) Featured in Oral Presentation at the ESGO Annual Meeting

The European Society of Gynecological Oncology 2024 Conference has recently made selected abstracts available online.

March 4, 2024
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2 min read
Pharm Country

ANEW MEDICAL Announces Key Patent Issued in China to Protect Klotho Protein and Gene Delivery Systems

ANEW MEDICAL, INC. announced that is has been granted and issued a patent in China, number CN 117126829 A for the use of ANEW’s Klotho protein and Klotho gene delivery and expression systems in the treatment of cognition, memory and neurodegenerative diseases.

March 4, 2024
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7 min read