Manufacturing: Page 32
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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 -
Cell therapy emergence opens up new markets for shippers, logistic companies
Companies like GE Healthcare and Cryoport have expanded their capabilities to help solve the challenges of preserving and shipping patient cells.
By Ned Pagliarulo • Sept. 7, 2017 -
Hospira recalls 5 lots of injectable drugs over sterility concerns
Similar worries were behind a June recall of sodium bicarbonate.
By Suzanne Elvidge • Sept. 7, 2017 -
OpinionThe digitalization productivity bonus in pharma manufacturing
Digitalization and data analytics can help companies in the sector reduce the high levels of downtime typically experienced by pharmaceutical plants.
By Chris Wilkinson • Aug. 31, 2017 -
FDA hits yet another Indian drugmaker with warning letter
Following a December inspection, the agency determined equipment maintenance and quality controls at a Hetero Labs manufacturing facility were inadequate.
By Jacob Bell • Aug. 31, 2017 -
FDA warns Florida stem cell clinic about GMP deviations
The FDA has warned U.S. Stem Cell Clinic about a host of issues, including violations of GMP.
By Suzanne Elvidge • Aug. 31, 2017 -
Landmark approval won, Novartis' next test is scaling CAR-T manufacturing
Treating patients with the pioneering cell therapy will require reliably transporting human cells through a complex logistics chain.
By Ned Pagliarulo • Aug. 31, 2017 -
US, EU advance collaboration efforts on manufacturing
The FDA has agreed to share more complete confidential information per the terms of a freshly inked agreement with other regulatory bodies.
By Jacob Bell • Aug. 24, 2017 -
Micro-Sphere expands facility in Switzerland
Increased demand in dry-powder formulations has pushed the CDMO to expand its manufacturing capabilities.
By Lisa LaMotta • Aug. 24, 2017 -
Novo manufacturing subsidiary completes Budapest expansion
Xellia Pharmaceuticals has a new 32,000-square-foot facility to boost its anti-infective production capabilities.
By Jacob Bell • Aug. 24, 2017
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