January 7, 2025 – Talk Bio

FDA Advisory Panels: Activity Levels Normalize After 2023 Surge

4 months ago talkbio0Tagged Advisory Committees, Advisory Panels, Meetings, regulatory, United States Food and Drug Administration

FDA advisory panels, adcomms, regulatory changes, advisory committee meetings

Denali Therapeutics’ ALS Drug DNL343 Fails to Meet Primary Efficacy Endpoints in Phase 2/3 HEALEY ALS Platform Trial

4 months ago talkbio0Tagged Agonist, Amyotrophic Lateral Sclerosis, Clinical trial failure, Denali, DNL343, Eukaryotic Initiation Factor-2B, HEALEY, Neurodegenerative Disorders

Denali Therapeutics, DNL343, ALS (Amyotrophic Lateral Sclerosis), HEALEY ALS Platform Trial, eIF2B agonist, Clinical trial failure, Neurodegenerative diseases

J&J’s Rybrevant Combination Therapy Outperforms AstraZeneca’s Tagrisso in Lung Cancer Survival Trial

4 months ago talkbio0Tagged AstraZeneca, Combined Modality Therapy, J&J, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Rybrevant, survival trial, Tagrisso

J&J, Rybrevant, AstraZeneca, Tagrisso, lung cancer, NSCLC, survival trial, combination therapy

WuXi Biologics Divests Irish Vaccine Facility to Merck for $500 Million Amid Strategic Shift

4 months ago talkbio0Tagged asset, Biological Factors, BIOSECURE, Dundalk, Facility (object), Ireland, Merck, regulatory, Sales - occupational activity, strategic shift, Vaccines, WuXi

WuXi Biologics, Merck, vaccine manufacturing facility, Dundalk, Ireland, asset sale, strategic shift, regulatory changes, Biosecure Act

Moderna CEO Reflects on 2024 Challenges and Advances in Shareholder Letter

4 months ago talkbio0Tagged 2024, COVID19 (disease), Letter [Publication Type], Moderna, mRNA medicines, Respiratory syncytial virus, Review [Publication Type], shareholder, Stéphane Bancel, Vaccines

Moderna, shareholder letter, 2024 review, RSV vaccine, COVID-19 vaccine, mRNA medicines, Stéphane Bancel

Oculis’ Novel Peptidomimetic OCS-05 Shows Promising Results in Phase 2 Trial for Acute Optic Neuritis

4 months ago talkbio0Tagged acute optic neuritis, Neuroprotective Therapy, OCS-05, Oculis, Peptidomimetics, Phase 2 trial

Oculis, OCS-05, Peptidomimetic, Acute Optic Neuritis, Neuroprotective Therapy, Phase 2 Trial, ACUITY Trial

Merck Acquires WuXi Biologics’ Irish Vaccine Facility in $500M Deal

4 months ago talkbio0Tagged Biological Factors, Facility (object), Ireland, Merck, pharmaceutical manufacturing, Vaccines, WuXi

Merck, WuXi Biologics, vaccine facility, Ireland, $500M deal, pharmaceutical manufacturing

Orbis Medicines Secures €90 Million Series A Funding to Revolutionize Oral Macrocycle Drug Discovery

4 months ago talkbio0Tagged biologic drug alternatives, Funding, nCycles, Oral Macrocycle, Orbis Medicines, pharmaceutical innovation, Series

Orbis Medicines, Series A funding, oral macrocycle drugs, nCycles, biologic drug alternatives, pharmaceutical innovation

I-Mab Reprioritizes Pipeline, Halts CD73 Antibody Development to Focus on Givastomig

4 months ago talkbio0Tagged 5'-NUCLEOTIDASE, Antibodies, Antibodies, Bispecific, Givastomig, I-Mab, Immunotherapy for cancer, metastatic gastric cancers, pipeline, reshuffle, Uliledlimab

I-Mab, pipeline reshuffle, CD73 antibody, uliledlimab, givastomig, CLDN18.2 x 4-1BB bispecific antibody, cancer immunotherapy, metastatic gastric cancers