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46-60 of 1845 results
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
Inovio’s Zika vaccine evokes strong immune responses in first human trial
By PBR Staff Writer
Inovio Pharmaceuticals said that its DNA-based Zika vaccine (GLS-5700) induced robust immune responses in an early-stage study in human volunteers who have not been infected with the virus.
Production & Manufacturing > Process & Production > News
ViiV Healthcare starts HIV prevention study with cabotegravir
By PBR Staff Writer
ViiV Healthcare has commenced a phase III study to assess cabotegravir, a long-acting injectable integrase strand transfer inhibitor, for the prevention of HIV infection.
Production & Manufacturing > Process & Production > News
46-60 of 1845 results