Manufacturing: Page 33
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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 -
Sponsored by Pfizer CentreOne
The value of the embedded-CMO model
Should you consider a CMO’s operating model when choosing a manufacturing partner? Read about the value of the embedded CMO, and why Pfizer chose that model for its contract manufacturing business, Pfizer CentreOne.
Aug. 24, 2017 -
Oxford Genetics tags new funding for US, UK expansion
With a £7.5 million investment in hand, the synthetic biology company plans to build out its cell engineering and vector production capabilities.
By Suzanne Elvidge • Aug. 24, 2017 -
FDA
Valeant says FDA to reclassify troubled Tampa plant
Such action should help eliminate regulatory uncertainties for products manufactured at the site, according to the Canadian drugmaker.
By Ned Pagliarulo • Aug. 17, 2017 -
FDA flags drugmaker's testing of potentially poisonous powders
The agency took a dim view of Homeolab USA's manufacturing processes, including those for its belladonna-containing powder blend.
By Jacob Bell • Aug. 17, 2017 -
GSK opens £44M aluminum salts facility in Scotland
With the expansion, the British drugmaker will be able to supply the key ingredient for 70% of its vaccines portfolio.
By Suzanne Elvidge • Aug. 17, 2017 -
Biocon pulls EU application for Herceptin biosimilar
The European Medicines Agency informed Biocon it would need to re-inspect the Indian manufacturer's drug product facility, triggering the withdrawal.
By Suzanne Elvidge • Aug. 17, 2017 -
PharmaTech liquid drugs possibly contaminated, FDA says
One distributor, Rugby Laboratories, has already announced a recall of two liquid docusate products manufactured by PharmaTech.
By Ned Pagliarulo • Aug. 10, 2017 -
England starts prioritizing patients amid global hep B vaccine shortage
The decision comes as Merck and GSK work to restore vaccine supplies.
By Jacob Bell • Aug. 10, 2017 -
Pfizer to invest $100M in build-out of gene therapy site
Pfizer acquired the Sanford, NC-based facility as part of its $645 million acquisition of Bamboo Therapeutics last year.
By Suzanne Elvidge • Aug. 10, 2017 -
Manufacturing issues threaten delay for Aerie eye drug
But Aerie believes the issues at its third party manufacturer's facility will be resolved before the expected decision date for its glaucoma med Rhopressa.
By Ned Pagliarulo • Aug. 10, 2017 -
Opioid drugmakers may have to slash production under new DEA proposal
The agency is mulling a 20% reduction in the manufacturing of the Schedule II drugs for 2018.
By Jacob Bell • Aug. 9, 2017 -
Sponsored by Bioclinica
Accelerate your database lock using Clean Patient Optics
Using the powerful data visualization tools in Clean Patient Optics, study teams can uncover patterns about the status of patient data external to the EDC system for early identification of potential study problems.
Aug. 8, 2017 -
Closing Claris deal, Baxter set to invest in three new plants
Baxter expects the injectable drugmaker will bring it $55 million worth of incremental sales during 2017.
By Jacob Bell • Aug. 3, 2017 -
Embattled Teva slashes staff, manufacturing facilities
Lower-than-expected revenues in the second quarter, due to greater pressure on generics, is pushing the Israeli company to look at cost-cutting measures.
By Lisa LaMotta • Aug. 3, 2017 -
Seattle Genetics brings manufacturing in-house
In a $43 million deal, the Washington biotech bought a plant from Bristol-Myers Squibb, giving it more control of its supply chain.
By Suzanne Elvidge • Aug. 3, 2017 -
LabCorp strengthens its CRO standing with $1.2B Chiltern acquisition
The deal should expand the buyer's CRO workforce to more than 11,000 employees.
By Jacob Bell • July 31, 2017 -
Novartis taps Cryoport for CAR-T logistics support
The Swiss pharma is gearing up for an expected approval of its landmark leukemia treatment later this year, inking deals ahead of time to manage the complex manufacturing and supply chain requirements.
By Ned Pagliarulo • July 27, 2017 -
Tesaro lands licensing, supply agreements for Zejula
Two separate deals have Takeda handing over $100 million upfront for rights to the cancer med and STA Pharmaceutical providing the materials to make it.
By Jacob Bell • July 27, 2017 -
Corning invests $500M to build better glass packaging for pharma
Big drugmakers Merck and Pfizer have already expressed interest in using the Valor Glass product.
By Ned Pagliarulo • July 27, 2017 -
Endo closes plant, cuts hundreds of jobs
The Irish pharma is closing a plant in Alabama due to lower demand, a move that will lead to the loss of several hundred jobs.
By Lisa LaMotta • July 27, 2017
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