Manufacturing: Page 34
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Pfizer to open new R&D facility in Missouri
The new site is one part of Pfizer's push to improve its manufacturing network, which has been dogged with legacy issues inherited from the acquisition of Hospira.
By Barbara Boughton • June 29, 2017 -
Patheon maps out $45M investment in services network
The Dutch CDMO is in the midst of being acquired by Thermo Fisher for $7.2 billion.
By Ned Pagliarulo • June 29, 2017 -
Janssen gets EU nod for continuous manufacturing
European regulators have OK'd use of an HIV drug made through continuous manufacturing at a site in Puerto Rico.
By Jacob Bell • June 29, 2017 -
Chemicals giant BASF builds out ibuprofen API production
About $230 million will be put toward constructing a new plant in Germany and expanding an existing site in Texas.
By Ned Pagliarulo • June 29, 2017 -
Coherus cuts staff after FDA red light
The California-based company will lay off employees after getting handed a rejection from the FDA for its Neulasta biosimilar.
By Lisa LaMotta • June 28, 2017 -
Takeda set to open new German manufacturing facilities
Construction on the €100 million expansion has wrapped, adding new capacity to the Japanese drugmaker's Oranienburg site.
By Ned Pagliarulo • June 22, 2017 -
BMS sells Irish manufacturing facility to SK Biotek
The Korean drugmaker intends to operate the small molecule production site as a stand-alone CDMO.
By Barbara Boughton • June 21, 2017 -
Sponsored by World Courier
Expect the unexpected: Six potential logistics challenges
Conditions along shipping routes can change with little to no prior warning; prepare for unforeseen circumstances to ensure pharmaceuticals are not at risk.
June 20, 2017 -
FDA
Hospira recalls add to drug shortages
The Pfizer subsidiary is recalling a number of drug products, potentially exacerbating drug shortages for key products like injectable sodium bicarbonate solution.
By Suzanne Elvidge • June 19, 2017 -
Bristol-Myers Squibb recalls mislabeled Eliquis medications
One lot of the blood thinner Eliquis distributed nationwide included bottles with 2.5 mg tablets, mislabeled as Eliquis 5 mg.
By Barbara Boughton • June 15, 2017 -
BioMarin secures FDA approval for Ireland production facility
The Shanbally, Cork site is now cleared for bulk production of a key ingredient for Vimizim, a fast-growing product for the rare disease drugmaker.
By Ned Pagliarulo • June 15, 2017 -
New deal should help Baxter speed up generic injectables development
The agreement with Dorizoe Lifesciences covers more than 20 treatments for cancer, cardiovascular disease or infections.
By Jacob Bell • June 15, 2017 -
Courtesy of Sanofi
Sanofi continues biologics push, building on recent approvals
The French drugmaker expects to invest €600 million a year in biologics production over the next several years.
By Ned Pagliarulo • June 15, 2017 -
Opinion
J&J: Embrace change to transform healthcare supply chains
J&J's Chief Supply Chain Officer explains how incorporating outside insights and tapping digital innovation has made the pharma giant's value chain more responsive and nimble.
By Kathryn Wengel • June 15, 2017 -
A new wave of gene therapies ready to hit US shores
After decades of setbacks, a slew of next-gen gene therapies are ready to hit the U.S. market, prompting questions about manufacturing and pricing.
By Malorye Allison Branca • June 12, 2017 -
Aimmune Therapeutics completes Florida facility
The facility will produce AR101, a peanut allergy medication currently in late-stage testing.
By Lisa LaMotta • June 8, 2017 -
Takeda breaks ground on Irish manufacturing plant
The Japanese pharma is expanding an existing facility to bring several manufacturing capabilities under one roof for its oncology drug Ninlaro.
By Lisa LaMotta • June 8, 2017 -
CRISPR taps MaSTherCell to manufacture CAR-T therapies
The collaboration will begin with the development and manufacture of CTX101, an allogeneic CAR T-cell therapy for CD19-positve cancers.
By Barbara Boughton • June 8, 2017 -
FDA cites Braun Medical for repeat GMP violations
Inspections in 2013, 2014, 2015 and 2016 all flagged similar issues with the medical product manufacturer's production processes, triggering a warning letter.
By Ned Pagliarulo • June 1, 2017 -
Chiltern acquires Japanese CRO in Asia expansion bid
The multinational clinical services company acquired Integrated Development Associates, which has a base in Japan, Korea and Southeast Asia.
By Ned Pagliarulo • June 1, 2017 -
Merck adding more than 300 new jobs to Irish manufacturing plants
The new positions will be at two sites and include positions in engineering, operations and biochemistry, among others.
By Jacob Bell • June 1, 2017 -
FDA
Problems at Sun Pharma plant trip up drug approval
The Indian drugmaker has struggled to bring its Halol facility into compliance with FDA standards, hurting its ability to win U.S. drug approvals.
By Ned Pagliarulo • May 25, 2017 -
Granules India investing $35 million to expand Virginia facility
The investment is intended to build out the Virginia site’s R&D and manufacturing capacity as part of the company’s plans to broaden its U.S. footprint.
By Barbara Boughton • May 25, 2017 -
FDA highlights threat bacteria poses to water-based products
A recent multi-state outbreak of the Burkholderia cepacia infection has the agency warning drugmakers to thoroughly clean their equipment and establish procedures to safeguard their products' quality.
By Jacob Bell • May 25, 2017 -
J&J settles OTC manufacturing issue for $33M
A subsidiary of the pharma giant allegedly produced and distributed common OTC drugs from facilities that were out of compliance with manufacturing standards.
By Ned Pagliarulo • May 25, 2017
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