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USFDA awards Breakthrough Therapy designation to Novartis’ asciminib
pharmaceutical-business-review
February 10, 2021
Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).
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FDA Approves TEPMETKO for Metastatic Non-Small Cell Lung Cancer
americanpharmaceuticalreview
February 10, 2021
The U.S. Food and Drug Administration (FDA) approved TEPMETKO (tepotinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations.
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Lupin gets US FDA nod for Tavaborole Topical Solution
expresspharma
February 10, 2021
It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
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Freeline modifies clinical development plan for Hemophilia B programme
pharmaceutical-technology
February 10, 2021
Clinical-stage biotechnology company Freeline Therapeutics has announced a modification to the clinical development plan for its FLT180a programme for Hemophilia B.
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AbCellera gets EUA from US FDA for its antibody Bamlanivimab, along with Etesevimab for COVID-19
expresspharma
February 10, 2021
Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a million doses by mid-2021.
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FDA approves third gene therapy for large B-cell lymphoma
europeanpharmaceuticalreview
February 09, 2021
Breyanzi (lisocabtagene maraleucel) was approved on the 54 percent complete remission rate achieved in diffuse large B-cell lymphoma trials.
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FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC
americanpharmaceuticalreview
February 09, 2021
The U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping ...
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Rhizen Pharma’s partnered asset Umbralisib gets US FDA accelerated nod for relapsed or refractory marginal zone lymphoma, follicular lymphoma
expresspharma
February 09, 2021
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics at an IND stage (TGR 1202) in 2012.
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FDA casts doubt on clinical meaningfulness of Merck’s Keytruda trial data
pharmaceutical-technology
February 09, 2021
The US Food and Drug Administration (FDA) has cast doubt on the results from Merck’s KEYNOTE-522 trial of Keytruda (pembrolizumab) submitted to support its expanded label in treating triple-negative breast cancer (TNBC).
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FDA Announces Alert of Potential Risks Associated with Compounding of Remdesivir
americanpharmaceuticalreview
February 08, 2021
The U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 ...