Manufacturing: Page 41
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CMOs speed Citius Pharmaceuticals into Phase 3
Citius has brought on two CMOs to produce Mino-Lok for the clinical trial, which is slated to begin in 2017.
By Suzanne Elvidge • Sept. 15, 2016 -
Avara snaps up AstraZeneca plant
AstraZeneca had planned to close the England-based plant, which employs more than 200 employees.
By Lisa LaMotta • Sept. 8, 2016 -
Fresh off new funding, Moderna plans new manufacturing plant
The Cambridge-based biotech recently raised $474 million to add to its impressive cash haul.
By Ned Pagliarulo • Sept. 8, 2016 -
Cambrex expands manufacturing in Sweden
The New Jersey-based small molecule manufacturer opened a new facility to build out its large-scale capacity.
By Lisa LaMotta • Sept. 8, 2016 -
FDA
FDA renews ban on Indian drugmaker after fresh violations
Pan Drugs failed to maintain basic sanitary standards at its Vandodara facility, and FDA inspectors uncovered evidence of falsified documents.
By Ned Pagliarulo • Sept. 8, 2016 -
Onconova cuts staff further to save cash
The newest layoffs follow earlier job cuts back in February and are aimed at conserving funds in the wake of Baxalta cutting ties on a collaboration.
By Suzanne Elvidge • Sept. 1, 2016 -
In wake of generics deal, Teva to close New York plant
Closure of the Ponoma, New York-based facility would affect approximately 80 jobs, the Israeli generics maker said.
By Ned Pagliarulo • Sept. 1, 2016 -
Theranos stumbles in efforts to sell Zika test: report
The troubled blood-testing company withdrew its application for emergency use of the test after an FDA inspection, according to news reports.
By Ned Pagliarulo • Sept. 1, 2016 -
Frontida warned by FDA over GMP violations
The facility in question, while under ownership by Sun Pharma, had knowingly released 27 batches of potentially contaminated API, according to U.S. regulators.
By Suzanne Elvidge • Aug. 30, 2016 -
Actavis pulls Patheon-made pills
The generic drug maker, now part of Teva, pulled several lots of pills after tests revealed they didn't meet expectations.
By Lisa LaMotta • Aug. 25, 2016 -
Sagent recalls injectable antibiotic
One lot of Oxacillin is being pulled from the market after metal particulate was found in a vial of the drug.
By Ned Pagliarulo • Aug. 25, 2016 -
Fresenius Kabi invests $250M in manufacturing expansion
The investment will add production capacity at the German manufacturer's Illinois site.
By Suzanne Elvidge • Aug. 25, 2016 -
Automation drives Zenith's US expansion
Manufacturing software solutions provider Zenith Technologies recently expanded its footprint, opening two new offices on the West Coast.
By Suzanne Elvidge • Aug. 25, 2016 -
Pfizer to shed four Hospira sites
The move will lay off 104 people in Hospira’s former sites in Atlanta, Dallas, Los Angeles and King of Prussia, PA.
By Kirell Lakhman • Aug. 22, 2016 -
Piramel buys contract manufacturer Ash Stevens
The Indian company is expanding its North American presence and ability to manufacture different types of pharmaceuticals.
By Lisa LaMotta • Aug. 18, 2016 -
Deep Dive
MI Labs to biotechs: Call us home
Founded last year, Mass Innovation Labs styles itself as a “chief operating officer” for emerging companies.
By Ned Pagliarulo • Aug. 16, 2016 -
Novartis expands plant ahead of expected growth
The big pharma is more than doubling its capacity at one of its biologics plants to prepare for expected strong product sales.
By Lisa LaMotta • Aug. 16, 2016 -
Sponsored by ICON plc
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Discover a convergence model driven by real-world intelligence and patient-centric innovation.
By Ramita Tandon, Executive Vice President Commercialisation & Outcomes, ICON plc • Aug. 16, 2016 -
FDA
Valeant nearing resolution of CRL, Papa says
The FDA initially rejected Valeant's application for approval of an eye drug over violations at a manufacturing facility in Tampa, FL.
By Lisa LaMotta • Aug. 11, 2016 -
NIH shuts down facility used to produce drugs for clinical trials
Inspections by the FDA last year revealed serious violations of proper manufacturing processes, prompting a sweeping review of all sterile production at the national medical research agency.
By Ned Pagliarulo • Aug. 10, 2016 -
Pfizer temporarily shutters Indian facility after inspections
Acquired in last year's Hospira deal, the site near Chennai had previously been flagged by U.S. regulators in 2013 for manufacturing violations.
By Ned Pagliarulo • Aug. 9, 2016 -
Deep Dive
Seizing CAR-T lead, Kite readies commercial-scale manufacturing
Along with safety, the ability to quickly manufacture the first wave of CAR-T therapies will likely be a key test of commercial viability.
By Ned Pagliarulo • Aug. 9, 2016 -
Pfizer cuts 151 jobs at New York plant
The cuts to the Pearl River site come as Pfizer expands its manufacturing operations elsewhere.
By Ned Pagliarulo • Aug. 4, 2016 -
Teva bolsters generics consolidation with purchase of Allergan's distributor
Teva will pay Allergan $500 million for Anda Inc., the fourth largest wholesale distributor of generics in the U.S.
By Edwin Lopez • Aug. 4, 2016 -
FDA
Chinese drug manufacturer lies to FDA, promptly gets banned
In a particularly deadpan warning letter to Xiamen Origin Biotech, the FDA slammed the API producer for misleading customers and lying to a FDA inspector.
By Nicole Gray , Ned Pagliarulo • Aug. 4, 2016
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