Manufacturing
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SponsoredLiving on a slope: Agile commercial strategies for IDN success
Why adopting an agile commercial strategy in medtech is like 'living on a slope.'
By Bret Caldwell, Principal, ZS
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FDA says Florence unlikely to cause critical device shortages
The agency is closely monitoring 10 sites that make critically important devices and biological products.
By Nick Paul Taylor • Sept. 20, 2018
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Cook resolves FDA warning letter that slammed quality processes
The close-out letter follows four years of work to improve quality management.
By Nick Paul Taylor • Sept. 12, 2018
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Becton Dickinson sells bioprocessing business to Thermo Fisher
Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.
By Susan Kelly • Sept. 10, 2018
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How TraceLink will use $93M in new funds to showcase the benefits of serialization
The data network plans to expand into a life sciences software suite to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.
By Edwin Lopez • Aug. 23, 2018
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FDA extends EpiPen expiration date to ease shortages
Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.
By Suzanne Elvidge • Aug. 22, 2018
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SponsoredThe end of the "Features War": The changing definition of value in Medtech
In today’s evolving hospital environment, features simply are not enough: Products must create indisputable value.
By Brian Chapman
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With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.
By Nick Paul Taylor • UPDATED: Aug. 15, 2018 at 11:47 a.m.
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Baxter boosts 2018 outlook but IV bag supply still under pressure
"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO José Almeida told investors.
By David Lim • July 26, 2018
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Deep DivePharma and AI? Let's try augmented intelligence first
Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.
By Lisa LaMotta • July 23, 2018
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Industry seeks clarity on latest FDA Pre-Cert working model
A software coalition questioned the agency's statutory authority to run a pilot test in 2019.
By David Lim • July 19, 2018
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Cannabis-based drugs and devices: A winning combo?
Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.
By Barbara Boughton
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Biogen looking to expand into medtech: report
The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes.
By Lisa LaMotta • July 16, 2018
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US imposes 25% tax on $836M in Chinese medtech imports
The extent of the tariffs represent a minor victory for the medtech industry, which lobbied to bring the value of products covered by the levy down from nearly $3 billion.
By Nick Paul Taylor • July 10, 2018
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GE to spin off healthcare unit in latest restructuring
Moody's and investors applauded the move, which comes amid a reboot of the health division.
By Meg Bryant • June 27, 2018
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UPS seeks to disrupt implantable medical device supply chain
But without device manufacturer buy-in, uptake of the effort appears to be slow.
By David Lim • June 05, 2018
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Hospitals facing IV solution shortages after Hurricane Maria
The FDA has granted one of the largest manufacturers of IV solutions permission to import IV bags from its facilities in other countries.
By David Lim • Nov. 16, 2017