Eugene

[email protected]

LATEST

Roche Partners with Enable Injections for Wearable Infusion Devices
By

By
Roche’s Genentech and Enable Injections, a developer and manufacturer of investigational wearable infusion devices for combination products, have partnered for multiple programs using Enable’s en-Fuse platform, a drug-delivery device designed…

Pfizer Recalls Two Lots of Migraine Drug Relpax for Potential Microbiological Contamination
By

By
Pfizer has issued a voluntary recall to the patient level of two lots of Relpax (eletriptan hydrobromide) 40 mg tablets, a drug to treat migraines, for potential microbiological contamination. Pfizer…

FDA OKs New Molecular Entities from Bayer, Merck & Co. and Daiichi
By

By
A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA)’s Center for Drug Evaluation and Research (CDER), featuring NME approvals from Bayer, Merck…

Samsung BioLogics Advances Perfusion Biomfg; Colorcon Partners for Drug Authentication
By

By
The latest news from CDMOs, CMOs, and suppliers featuring news from Samsung BioLogics,  Colorcon and Halix. Biologics Manufacturing Samsung BioLogics Advances Large-Scale Perfusion Technology for Commercial Biomanufacturing  Samsung BioLogics, a…

Perrigo Still in Preparation to Separate Rx Pharmaceutical Business
By

By
Perrigo, a pharmaceutical company of generic drugs and over-the-counter (OTC) products, specified in its second-quarter 2019 results that it has not set a specific date for its previously announced plan…

Novartis’ Sandoz Loses Court Ruling Over its Biosimilar to Amgen’s Blockbuster Drug Enbrel
By

By
A federal district court judge has ruled against Sandoz, the generics business of Novartis, in patent litigation relating to Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug, Enbrel (etanercept), an…

Senator Grassley Requests FDA Inspect Foreign Drug Plants Unannounced
By

By
Senator Chuck Grassley (R-IA), Chairman of the US Senate Finance Committee, has submitted a letter to US Department of Health and Human Services’ (HHS) Secretary Alex Azar and the US…

GSK Names New US Pharmaceutical Head
By

By
GlaxoSmithKline’s (GSK) President of US Pharmaceuticals, Jack Bailey, has decided to step down from his role at the end of 2019. GSK has appointed Maya Martinez-Davis, currently Regional President, Latin…

FDA Addresses Product-Testing Issues in Mfg Process for Novartis’ Gene Therapy Zolgensma
By

By
The US Food and Drug Administration (FDA) has issued a statement addressing product-testing data used to support the production process in the biologics license application (BLA) for Novartis’ Zolgensma (onasemnogone…

BI, MD Anderson Cancer Center Partner for Cancer Research and Virtual R&D Center
By

By
Boehringer Ingelheim (BI) and the University of Texas MD Anderson Cancer Center have formed a multi-year partnership to conduct collaborative research on therapies for various types of cancers, including the…