Manufacturing: Page 31
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Lilly to spend $72M on upgrading insulin production
The Indianapolis pharma has earmarked $850 million for investments into its U.S. operations this year.
By Ned Pagliarulo • Oct. 26, 2017 -
Single-source contracting could speed drug development
Outsourcing to a single CMO rather than multiple for manufacturing support proved faster and less costly, a Tufts study found.
By Suzanne Elvidge • Oct. 26, 2017 -
With generics market calling, Cambrex outfits Milan facility
The API and generics manufacturer sees an opportunity for growth as certain highly potent molecules near patent expiration.
By Jacob Bell • Oct. 19, 2017 -
J&J says Puerto Rico plants returning to full operations
All of J&J's six manufacturing plants on the island are open, but the drugmaker couldn't rule out the possibility of intermittent supply shortages for certain drugs.
By Ned Pagliarulo • Oct. 19, 2017 -
Sponsored by Abbvie
CPhI Worldwide: Q&A on bilayer tablet manufacturing
Manufacturing bilayer tablets has its own unique challenges for CDMO's. Dr. Éanna Ó Maitiú, Technical Operations Manager, at AbbVie Cork, Ireland discusses the special considerations Abbvie takes into account regarding the manufacturing of these medications.
By Dr. Éanna Ó Maitiú, Technical Operations Manager at AbbVie Cork, Ireland • Oct. 19, 2017 -
Novartis shuts Colorado generics facility, cutting 450 jobs
A tightening generics market in the U.S. has prompted the Swiss pharma to consolidate production and discontinue or sell several low-growth products.
By Suzanne Elvidge • Oct. 19, 2017 -
MassBio: Massachusetts edges out California as #1 biotech hub
A recent report shows there are now more biopharma jobs in the Boston area than any other place in the U.S., while funding to the area continues to flow.
By Jacob Bell • Oct. 17, 2017 -
Pfizer sells off Colorado facility to CordenPharma
The Colorado site is one of several legacy Hospira sites that the pharma giant has sought to divest as it reshapes its manufacturing network.
By Ned Pagliarulo • Oct. 12, 2017 -
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
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