Manufacturing: Page 32
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Biocon manufacturing problems stall another one of its biosimilars
The FDA rejected Biocon and Mylan's version of Neulasta as the agency awaits more chemistry, manufacturing and controls data for a recently modified facility.
By Jacob Bell • Oct. 12, 2017 -
Sanofi commits €170M to expand flu vaccines production
Vaccines are a sizable and fast-growing business for the French drugmaker, which is one of the leading players in the space.
By Ned Pagliarulo • Oct. 12, 2017 -
J&J invests $355M in Ireland, creates new jobs
Janssen Sciences Ireland is expanding its Country Cork facility, boosting manufacturing and creating new jobs.
By Suzanne Elvidge • Oct. 12, 2017 -
Sponsored by Pfizer CentreOne
Is your API ready for scale-up? What to demand from your CDMO
A CDMO that can optimize your API synthesis process early during technology transfer will reduce the risk of project delay or failure. That will also help your molecule run more efficiently in their plant. And time is money.
By Justin A. Divan, Manager, Project Management, Pfizer CentreOne • Oct. 11, 2017 -
Bio-Rad shutters Cambridge facility
The clinical diagnostics tool manufacturer is consolidating its research and development at a site in California.
By Suzanne Elvidge • Oct. 10, 2017 -
Merck KGaA invests in Italian manufacturing site
The German company is putting money into a 25-year-old manufacturing site as it increases production of biotech drugs.
By Lisa LaMotta • Oct. 5, 2017 -
Lonza snatches Shire facility as biologics manufacturing rakes in returns
The drug developer expects the new site will complement operations from another mammalian manufacturing plant in the U.K.
By Jacob Bell • Oct. 5, 2017 -
Abeona breaks ground on gene therapy manufacturing site
Construction is starting on what could be Ohio's first commercial gene therapy manufacturing facility.
By Suzanne Elvidge • Oct. 5, 2017 -
With solid results in hand, Gilead inks manufacturing deal for HIV med
A combination including bictegravir showed non-inferiority in a late-stage trial of HIV patients, prompting Gilead to set contracts that allow the drug to be generically manufactured for low-income countries once approved.
By Lisa LaMotta • Oct. 4, 2017 -
FDA looking to clear path to market for complex generics
In his latest blog post, Commissioner Scott Gottlieb outlined how the agency will work to increase competition for pricey pharmaceuticals.
By Jacob Bell • Oct. 2, 2017 -
AveXis gets FDA nod to start pivotal gene therapy trial
Following a change to GMP manufacturing, AveXis secured the regulator's go-ahead for an immediate initiation of its SMA gene therapy trial.
By Suzanne Elvidge • Oct. 2, 2017 -
Abeona taps Brammer Bio for gene therapy manufacturing support
The partnership will focus on readying commercial AAV process development as Abeona advances its treatment for Sanfilippo syndrome type A.
By Ned Pagliarulo • Sept. 28, 2017 -
AmerisourceBergen hands over $260M for a decade of illegal drug manufacturing
A subsidiary of the drug distributor pleaded guilty to federal charges it sold cancer drugs produced at an Alabama plant that wasn't registered with the FDA.
By Jacob Bell • Sept. 28, 2017 -
Chinese drugmaker warned by FDA for faking lab records
Shandong Vianor's refusal to let the FDA's inspector into a laboratory didn't help.
By Suzanne Elvidge • Sept. 28, 2017 -
Intarcia loses some of its sparkle with FDA rejection
The FDA flagged issues with the biotech unicorn's manufacturing practices, denting the blockbuster promise of its diabetes drug-device combo.
By Lisa LaMotta • Sept. 28, 2017 -
Without power, Puerto Rico's drug manufacturing left battered by Maria
The FDA has been working with drugmakers to bring sites back on line after Hurricane Maria damaged much of the island's infrastructure.
By Ned Pagliarulo • Sept. 25, 2017 -
FDA
Intellipharmaceutics receives painful FDA rejection
The agency said it needs more data demonstrating extended-release oxycodone's abuse deterrence profile.
By Jacob Bell • Sept. 25, 2017 -
Big pharma builds blockchain prototype to stop counterfeits
The MediLedger Project brings together pharma supply chain stakeholders like Pfizer and McKesson to build a system that could register and verify drugs.
By Edwin Lopez • Sept. 21, 2017 -
Korean drugmaker used employees to test potentially harmful ointment, FDA says
Firson Co. Ltd. is one of two Asian pharma manufacturers recently flagged by the agency for manufacturing violations.
By Jacob Bell • Sept. 21, 2017 -
Brammer Bio doubles manufacturing capacity at Florida site
Completion of the expansion should help the gene therapy CDMO better support early-stage clinical trials.
By Ned Pagliarulo • Sept. 21, 2017 -
Fujifilm opens new mammalian cell facility
The 10,000-square-foot facility expands the Japanese firm's footprint in the U.K.
By Jacob Bell • Sept. 14, 2017 -
FDA calls for industry input on continuous manufacturing guidelines
Biopharmas largely haven't adopted the speedier and more adaptable approach to drug manufacturing, relying instead on tried-and-true batch production methods.
By Ned Pagliarulo • Sept. 14, 2017 -
NYC's research lab construction market is heating up
The city's 1.7 million square feet of lab space is fully occupied, with little new space in the works.
By Mary Tyler March • Sept. 12, 2017 -
Pfizer's EpiPen manufacturer warned by FDA
The agency found glaring issues with how the site handled quality control, complaints and defective auto-injectors.
By Jacob Bell • Sept. 8, 2017 -
FDA
Integration a key focus of FDA's new drug review model
Agency head Scott Gottlieb plans to create more integrated teams to boost information sharing between staff scrutinizing new drugs and those reviewing manufacturing facilities.
By Jacob Bell • Sept. 7, 2017
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