Manufacturing: Page 37
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GlaxoSmithKline expanding vaccine production in Hungary
Vaccines have become a larger part of the British pharma's business and will be an important source of growth as Advair's patent expiry crimps revenue.
By Suzanne Elvidge • March 16, 2017 -
Alexion to cut R&D, 7% of workforce
The moves are part of a larger restructuring effort for the embattled drugmaker, which has seen leadership turnover amid an internal investigation.
By Jacob Bell • March 14, 2017 -
Nicox resubmits eye drug to FDA after manufacturing setback
Issues with an API contractor tripped up Nicox's new drug application for Zerviate last year. With that now resolved, Nicox hopes to win secure approval.
By Ned Pagliarulo • March 9, 2017 -
Apotex invests in Florida manufacturing
The generics drugmaker is expanding its manufacturing presence in South Florida, hoping to increase its U.S. presence and Latin American influence.
By Lisa LaMotta • March 9, 2017 -
FDA
Indian drugmaker slammed for repeated GMP failures
Over the past four years, the FDA flagged violations at seven separate Wockhardt facilities, leading the frustrated regulator to demand a company-wide review.
By Ned Pagliarulo • March 9, 2017 -
Beigene plans $330M biologics facility in China
The Chinese biotech is partnering with one of the country's national Economic and Technological Development Zones to finance the plant's construction.
By Jacob Bell • March 8, 2017 -
Montgomery County Planning Commission
Report: Why Merck turned to supply chain integration to save costs
The big pharma is transforming its supply chain in and effort to cut costs and increase efficiency.
By Edwin Lopez • March 2, 2017 -
FDA
FDA, EU amendment looks to crack down on duplicate inspections
A newly minted amendment to the U.S.-E.U. Mutual Recognition Agreement allows the parties to use each others' inspection information.
By Jacob Bell • March 2, 2017 -
Struggling Ohr shutters San Diego lab
After suspending work at a lab in San Diego, the biotech cuts jobs.
By Suzanne Elvidge • March 2, 2017 -
Pfizer flagged for more manufacturing issues
The FDA slammed Pfizer in a new warning letter, stating that, among other problems, the drugmaker failed to properly investigate cardboard contaminants at a Kansas-based Hospira plant.
By Jacob Bell • March 1, 2017 -
La Jolla surges on Phase 3 results for shock patients
The San Diego-based company says its synthetic formulation of a blood-pressure regulator offers a new level of treatment for shock patients who fail first- and second-line therapies in the ICU.
By Judy Packer-Tursman • Feb. 27, 2017 -
Why drug pricing seems so complicated
Experts say pharma companies need to get better at incorporating clinical value into pricing and communicating this value.
By Judy Packer-Tursman • Feb. 27, 2017 -
Cold chain integrity, visibility top of mind for pharmaceutical shippers
Panelists representing Teva, Sandoz and freight forwarders identified top challenges in assuring drug quality at a recent conference.
By Edwin Lopez • Feb. 23, 2017 -
Pharma CEOs sign on to letter urging tax reform
Changes to the tax code, such as a move towards territorial taxation or border adjustment, could push drug manufacturers to move production back to the U.S.
By Ned Pagliarulo • Feb. 23, 2017 -
Momenta's Copaxone generic delayed following Pfizer warning letter
The FDA is unlikely to determine the drug's approval status in the first quarter, the company said.
By Jacob Bell • Feb. 23, 2017 -
Dr. Reddy's hits roadblock in re-inspection of India plant
The India-based drugmaker said the FDA issued a Form 483 over problems at a manufacturing facility first flagged by U.S. regulators two years ago.
By Judy Packer-Tursman • Feb. 23, 2017 -
Sponsored by World Courier
Global logistics strategies for cell and gene therapies
In order to ensure the success of clinical trials, another industry has to evolve: logistics.
Feb. 21, 2017 -
FDA warns another Japanese drug manufacturer over GMP flaws
Tokyo-based Sato Pharmaceutical Co. is the third Japanese drugmaker in six months to run afoul of the FDA's inspectors.
By Ned Pagliarulo • Feb. 16, 2017 -
Daiichi shutters Japanese plant amid restructuring efforts
Asubio Pharma Co. is now the second R&D closure this year for the Japanese drug manufacturer.
By Jacob Bell • Feb. 16, 2017 -
Quotient buys QS Pharma, expanding US footprint
QS Pharma is Quotients’s second U.S. acquisition in the past eight days, following right on the heels of its purchase of Florida-based SeaView Research.
By Judy Packer-Tursman • Feb. 16, 2017 -
Takeda, PRA expand R&D partnership into Japan
Less than half a year after first pairing up, the two companies are creating a new joint venture to support Takeda's drug development work in its home base.
By Suzanne Elvidge • Feb. 16, 2017 -
Biomarkers: What you need to know
A closer look at what biomarkers are, how they are driving the industry and who is utilizing them well.
By Lisa LaMotta • Feb. 15, 2017 -
Pfizer plans to close Australian manufacturing plant
An evaluation of manufacturing operations following the company's acquisition of Hospira led to the decision to shutter the Adelaide-based plant by the end of 2021.
By Jacob Bell • Feb. 9, 2017 -
Sanofi, Regeneron set to resubmit sarilumab
Manufacturing headaches had derailed the drug last fall, but the duo expects to send an application back to the FDA sometime this quarter.
By Suzanne Elvidge • Feb. 9, 2017 -
FDA
AMRI builds out drug discovery tech
A new alliance gives the New York-based company access to a high throughput mass spectrometry system.
By Judy Packer-Tursman • Feb. 9, 2017
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