Manufacturing: Page
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Flexion taps Thermo Fisher's flexible manufacturing for Zilretta
The biotech relies on the scientific instrument maker's Patheon unit as its sole supplier of finished drug product.
By Suzanne Elvidge • Jan. 17, 2018 -
FDA works to ease IV shortages after Hurricane Maria
Saline and drug shortages triggered by the storm's effects still pose a challenge for U.S. hospitals and providers.
By Suzanne Elvidge • Jan. 17, 2018 -
JPM18: Teva cutting up to 25 manufacturing sites within 2 years
It's the latest cost-savings move as the struggling Israeli drugmaker moves to rightsize itself.
By Jacob Bell • Jan. 11, 2018 -
Adaptimmune manufactures first dose of cell therapy, signs vector deal
The new facility can deliver cells for up to 300 patients a year, with potential expansion of up to 1,000 patients per year.
By Suzanne Elvidge • Jan. 11, 2018 -
Elizabeth Regan/BioPharma Dive
Boehringer, BeiGene enter manufacturing pact for PD-1 drug
In a hookup with the German drugmaker, BeiGene gets a boost for tislelizumab production.
By Suzanne Elvidge • Jan. 11, 2018 -
As biopharma supply chains streamline, companies consolidate
An EY report details big changes — including the return of the "mega-merger" — coming to pharmaceutical companies and their supply chains.
By Kate Patrick Macri • Jan. 10, 2018 -
Distributors fire back against opioid lawsuits
Facing a wave of lawsuits, a pharmaceutical distribution group wants to correct the record on its role within the opioid supply chain.
By Edwin Lopez • Jan. 9, 2018 -
FDA aims to strengthen oversight of compounded drug manufacturing
While changes have been made since a 2012 meningitis outbreak, large-scale drug compounding still poses risks, an update from the FDA cautions.
By Ned Pagliarulo • Jan. 4, 2018 -
Fresnius Kabi's investigations aren't up to snuff, says FDA
The German drugmaker has repeatedly failed to identify what's causing sterility issues at its plants, pushing the FDA to issue two warning letters last month.
By Jacob Bell • Jan. 4, 2018 -
Shire seeks FDA sign-off on plasma manufacturing facility
Bringing the Covington, GA site on line will add 30% to Shire's plasma production capacity, helping support a growing immunology business.
By Suzanne Elvidge • Jan. 4, 2018 -
GSK taps Viant to test blockchain-based tracking
Blockchain developers believe the tech is ideally suited to serve the biopharma industry's supply chain needs.
By Jennifer McKevitt • Jan. 3, 2018 -
Fujifilm invests in gene therapy startup
The Japanese photography company has turned its focus to drugmaking in recent years, as illustrated by its new equity stake in EdiGene Corp.
By Jacob Bell • Dec. 21, 2017 -
MilliporeSigma tapped by bluebird for manufacturing
For bluebird, the deal is another step toward solidifying a stronger production process for its gene therapies.
By Jacob Bell • Dec. 21, 2017 -
Elizabeth Regan/BioPharma Dive
Deep Dive
Regulatory reforms unstick CMO market in China
A pilot scheme introduced by the Chinese government has given domestic biopharma companies more flexibility to tap CMOs for their manufacturing needs.
By Wang Fangqing • Dec. 21, 2017 -
Juno inks CAR-T supply deal with Thermo Fisher
Manufacturing is a key hurdle for cell therapy, pushing developers to be proactive in setting up production and supply chain processes during clinical development.
By Ned Pagliarulo • Dec. 21, 2017 -
FDA plans tougher enforcement of homeopathic medicines
Under a proposed risk-based approach, the regulator would target products claiming to treat serious diseases or that contravene manufacturing standards.
By Suzanne Elvidge • Dec. 20, 2017 -
EMA signs off on Samsung BioLogics manufacturing plant
The Korean drugmaker claims Plant No. 2, as it's known, is the world's single largest biologics plant, with 150,000 liters of production capacity.
By Ned Pagliarulo • Dec. 14, 2017 -
Abzena tapped for preclinical ADC development
The CDMO has entered into an agreement worth more than $5 million with a U.S. biotech.
By Jacob Bell • Dec. 14, 2017 -
FDA warns Korean OTC manufacturer for GMP violations
A recent warning letter from the regulator flagged labeling concerns and lax quality control on the part of the Seoul-based drugmaker.
By Ned Pagliarulo • Dec. 14, 2017 -
Biocad set to begin selling biosimilars in North Africa
Through a partnership with the Moroccan firm Sothema Labs, the Russian biotech hopes to manufacture and market its copycat biologics in the region.
By Suzanne Elvidge • Dec. 14, 2017 -
PwC: Opioids and Medicare pressures will challenge industry in 2018
BioPharma Dive Senior Editor Lisa LaMotta sat down with the US Pharma and Life Science Leader from PwC to discuss issues to watch in 2018.
By Lisa LaMotta • Dec. 12, 2017 -
Kendall Davis/BioPharma Dive
How can healthcare supply chains improve? Experts weigh in.
From supplier relations to inventory management, healthcare is seen as one of the greatest opportunities for supply chain improvement. Here's why.
By Edwin Lopez • Dec. 11, 2017 -
Wuxi preps for biologics manufacturing surge in China
The contract manufacturer recently began operations at what it says is the world's largest production facility for biologics using single-use bioreactors.
By Ned Pagliarulo • Dec. 7, 2017 -
FDA lays groundwork for regulating 3D-printed drugs
The agency says it's the first regulator in the world to provide technical guidelines for manufacturers seeking to make medical products on 3D printers.
By Jacob Bell • Dec. 7, 2017 -
Sponsored by Lee Industries
Meeting vessel fabrication challenges for Bio/Pharma applications
Proper installation and start-up of complex vessels for Bio/Pharma applications is critical to prevent installation damage and to ensure safe operation compliant with your company’s processing requirements.
Dec. 4, 2017
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