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Process & Production

FDA grants orphan drug designation to Concert's cystic fibrosis treatment By PBR Staff Writer
Concert Pharmaceuticals has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for CTP-656 to treat cystic fibrosis.
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EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
Production & Manufacturing > Process & Production > News Abeona gets orphan drug status in EU for ABO-101 gene therapy in Sanfilippo syndrome type B Abeona Therapeutics has secured orphan drug designation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products for its gene therapy program ABO-101 for children impacted by Sanfilippo syndrome type B (MPS IIIB).
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ProMetic's alstrom syndrome treatment gets orphan drug status in Europe
The European Commission has granted orphan drug designation to ProMetic Life Sciences' PBI-4050 drug for the treatment of Alström Syndrome.
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EMA and FDA to review Boehringer’s biosimilar candidate to Humira
Boehringer Ingelheim's BI 695501, the adalimumab biosimilar candidate to Humira, has been accepted for regulatory review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
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FDA extends review period by three months for rheumatoid arthritis candidate baricitinib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months for investigational rheumatoid arthritis treatment, Baricitinib.
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Heron submits CINVANTI NDA to FDA for CINV prevention
Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
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FDA grants QIDP status for RedHill's RHB-104 to treat nontuberculous mycobacteria infections
By PBR Staff Writer
RedHill Biopharma has secured the Qualified Infectious Disease Product (QIDP) fast-track designation from the US Food and Drug Administration (FDA) for its candidate RHB-104 to treat nontuberculous mycobacteria (NTM) infections.
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FDA to review Biocon and Mylan's biosimilar drug for breast cancer
By PBR Staff Writer
Netherlands-incorporated generics firm Mylan and Indian biopharmaceutical company Biocon are a step closer to secure approval for a biosimilar version of Roche’s cancer drug trastuzumab in the US.
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FDA accepts Merck's sBLA for lung cancer combo therapy
The US Food and Drug Administration (FDA) has accepted for review Merck's supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.
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FDA grants orphan drug status to Alexion Pharmaceuticals' ALXN1210
Alexion Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being assessed to treat patients with paroxysmal nocturnal hemoglobinuria (PNH).
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FDA grants priority review for Bayer's Stivarga marketing application for liver cancer
The US Food and Drug Administration (FDA) has granted priority review status for Bayer's supplemental New Drug Application (sNDA) for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC).
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FDA accepts to review Ironwood’s NDA for gout drug Duzallo
By PBR Staff Writer
Ironwood Pharmaceuticals’ new drug application (NDA) for its gout drug candidate, Duzallo, has been accepted for review by the US Food and Drug Administration (FDA).
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