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Process & Production

Cascadian Therapeutics amends HER2CLIMB phase 2 trial of tucatinib Cascadian Therapeutics announced that after a recent meeting with the US Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration.
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FDA grants fast track designation for Theravance's Velusetrag for idiopathic and diabetic gastroparesis Theravance Biopharma has secured fast track designation from the US Food and Drug Administration (FDA) to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.
Production & Manufacturing > Process & Production > News Novo Nordisk seeks US and EU approval for new type 2 diabetes treatment By PBR Staff Writer
Novo Nordisk is seeking approvals in the US and Europe for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, to treat adults with type 2 diabetes.
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Amgen and Allergan submit bevacizumab biosimilar application to EMA
Amgen and Allergan have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
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Shire's VONVENDI meets primary endpoint in controlling bleeding in VWD adults in phase 3 study
A phase 3 clinical trial of Shire's VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD) has met primary endpoint.
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Pfizer’s Glasdegib improves OS in AML and MDS patients in phase 2 trial
The new phase 2 results demonstrated that Pfizer's investigational compound Glasdegib improved overall survival (OS) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
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Agilis' AADC gene therapy candidate gets OMP designation in Europe
Agilis Biotherapeutics’ gene therapy product candidate, AGIL-AADC has secured Orphan Medicinal Product (OMP) designation from the European Commission (EC).
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Daiichi Sankyo’s breast cancer drug candidate gets FDA fast track designation
Daiichi Sankyo has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational HER2-targeting antibody drug conjugate DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).
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AbbVie’s risankizumab secures FDA orphan drug status for paediatric Crohn’s
AbbVie has secured Orphan Drug Designation from the US Food and Drug Administration (FDA) to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients.
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FDA grants priority review to EMD Serono’s BLA for avelumab for Merkel cell carcinoma
The US Food and Drug Administration (FDA) has granted priority review for EMD Serono’s biologics license application (BLA) of avelumab to treat metastatic Merkel cell carcinoma (MCC).
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FDA grants priority review to Merck’s sBLA for Keytruda for MSI-H cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review to Merck’s supplemental biologics license application (sBLA) seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high (MSI-H) cancer.
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Intellipharmaceutics seeks FDA approval for Rexista to treat moderate to severe pain
Intellipharmaceutics International has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ("FDA") seeking authorization to market its abuse-deterrent oxycodone hydrochloride extended release tablets branded as Rexista in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
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GSK seeks EU approval for shingles vaccine
GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its shingles vaccine candidate dubbed Shingrix, for herpes zoster (shingles) prevention in people aged 50 years or over.
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