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Process & Production

CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
Production & Manufacturing > Process & Production > News
FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia By PBR Staff Writer
Pfizer’s Mylotarg (gemtuzumab ozogamicin) has been recommended for approval by the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) to treat acute myeloid leukemia (AML).
Production & Manufacturing > Process & Production > News Amicus plans to submit NDA to FDA for migalastat for fabry disease Amicus Therapeutics has revealed its plans to file a new drug application (NDA) with the US FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of the year.
Production & Manufacturing > Process & Production > News
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BioMarin submits Pegvaliase BLA to FDA for treatment of phenylketonuria
BioMarin Pharmaceutical has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.
Production & Manufacturing > Process & Production > News
Russell Finex: High Capacity Production of APIs
Sri Krishna Pharmaceuticals greatly increase production of APIs with Russell Finex screening solutions
Production & Manufacturing > Process & Production > Press Releases
FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
Production & Manufacturing > Process & Production > News
Omeros’ OMS721 kidney drug gets FDA breakthrough therapy status
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy.
Production & Manufacturing > Process & Production > News
FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C
The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Production & Manufacturing > Process & Production > News
SYSTAG: The use of FlexyPAT-HFC for calorimetric measurements
| By SYSTAG
FlexyPAT is a modular Process Automation Technology that enables automated customer-specific lab reactor systems to be implemented in a very cost-effective manner, including with the integration of existing devices.
Production & Manufacturing > Process & Production > White Papers
SYSTAG: Efficient synthesis development
| By SYSTAG
Efficient synthesis development using the example of determi-nation of the metastable zone.
Production & Manufacturing > Process & Production > White Papers
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