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61-75 of 1862 results
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).
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
Ionis’ type 2 diabetes candidate shows positive results in phase 2 study
Ionis Pharmaceuticals has reported positive data from phase 2 study of IONIS-GCGR Rx in patients with type 2 diabetes.
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TRACON signs SPA deal with FDA for phase 3 trial of TRC105 in angiosarcoma
TRACON Pharmaceuticals has reached an agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the Company's Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma.
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Novelion’s subsidiary seeks European approval for metreleptin
Novelion Therapeutics’ subsidiary has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).
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Alexion’s eculizumab fails to meet primary endpoint in phase 2/3 trial
Alexion Pharmaceuticals has reported results from the PROTECT Study, a Phase 2/3 registration trial of eculizumab (Soliris) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney.
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61-75 of 1862 results