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Novo Recalls Injectors with Detached Needles

Thu, 2016-09-15 09:30
6 lots of GlucaGen HypoKit have been recalled due to faulty injectors that could lead to death for hypoglycemic patients.

Plexpack Corp.: Bag Sealer Software and Hardware Upgrades

Thu, 2016-09-15 09:11
The company’s Emplex MPS Series Bag Sealers receive multiple software and hardware enhancements.

Thermo Fisher Scientific Opens New State-of-the Art Clinical Services Facility in Korea

Wed, 2016-09-14 18:38
To address the growing global demand for clinical services, Thermo Fisher Scientific, the world leader in serving science, today announced the official opening of its new state-of-the-art GMP standard facility in South Korea.

Gerresheimer to Sell Life Science Research Business

Wed, 2016-09-14 18:35
Gerresheimer and Chase Scientific Glass, Inc. are to sell their joint venture

AVERY DENNISON ADDS 12 CONSTRUCTIONS TO INKJET PORTFOLIO

Wed, 2016-09-14 18:32
Avery Dennison is expanding its portfolio of high-performance inkjet products.

At Label Expo 2016, Domino welcomes you to “See More. Learn More. Do More.” as we introduce to the U.S. market N610i ‘Textures by DOMINO’, debut K600i double-white bar, conduct live demonstrations, bring our Open House to Rosemont, and invite you to enjoy

Wed, 2016-09-14 18:28
At Label Expo 2016 in booth 6523, Domino Digital Printing will be introducing to the U.S. market “Textures by Domino” on the N610i digital UV inkjet label press, debuting the K600i double-white bar digital UV inkjet printer, conducting live demonstrations, bringing our Open House presentations to Rosemont, and welcoming attendees to “See More. Learn More. Do More.” while enjoying morning and afternoon ‘brews’ and hospitality.

AVERY DENNISON RAISES THE SUSTAINABILITY BAR

Wed, 2016-09-14 18:21
A long-time advocate of sustainability,Avery Dennison Label and Packaging Materials is stepping up its efforts to raise the sustainability bar.

LIVE FROM PDA/FDA: An Overview of FDA’s Expectations of Biosimilars

Wed, 2016-09-14 13:05
Similar biological medicinal products are not the same as small-molecule generics in terms of their complexity or the approval process, which evaluates residual uncertainty at each step.

LIVE FROM PDA/FDA: FDA: Trends In Investigations of Poor Quality Systems

Wed, 2016-09-14 11:53
Investigations are a tough but necessary part of quality systems. Failure to adequately extend investigation is the most common problem the FDA sees.

Biogen Launches Remicade Biosimilar

Wed, 2016-09-14 09:30
Biogen introduces Flixabi in the UK, the third biosimilar competitor to Johnson & Johnson’s Remicade.

NJM Packaging: Dara Moduline NFL

Wed, 2016-09-14 06:00
Dara’s aseptic fill-and-finish system is integrated with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment.

LIVE FROM PDA/FDA: Compliance to Quality: Part 2

Wed, 2016-09-14 06:00
Retired Amgen Chief Quality Officer discusses building a quality culture from the top.

LIVE FROM PDA/FDA: Compliance to Quality: Part 1

Wed, 2016-09-14 05:00
CDER’s Office of Pharmaceutical Quality aims to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies.

Sappi North America: Casting and Release Paper

Tue, 2016-09-13 12:23
Neoterix ST reported as first commercial casting and release paper with Sharklet bacteria-inhibition technology.

LIVE FROM PDA/FDA: Regulated Biologics Offer Therapeutic Promise; Manufacturing Challenges

Tue, 2016-09-13 09:49
Many genetically modified cellular therapies are developed with relatively small safety and efficacy datasets from clinical trials. As a result, some are eligible for orphan designation, which allows for fast-tracking to market.

Aussie Packager Pact Group Buys Pharma Manufacturer

Tue, 2016-09-13 09:30
Pact Group Holdings Ltd. will pay $69M for Australian Pharmaceutical Manufacturers to expand production business.

LIVE FROM PDA/FDA: Industry Mobilizes to Fight Falsified Medicines

Tue, 2016-09-13 09:12
Pfizer representative emphasizes the significance of supply chain security from raw materials and APIs to pharmacies.

LIVE FROM PDA/FDA: Pharmaceutical Inspection Cooperation Scheme Seeks Global Harmonization

Tue, 2016-09-13 08:42
PIC/S membership is growing worldwide, yet China and India face regulatory and economic challenges.

LIVE FROM PDA/FDA: FDA Continues Focus on Keeping Public Safe in the Fight Against Counterfeit Drugs

Mon, 2016-09-12 21:06
FDA has made strides in identifying vulnerabilities and threats in the supply chain with the implementation of the DSCSA.

Determining the Impact of Packaging and Logistics on the CAR-T Clinical Pipeline

Mon, 2016-09-12 14:52
Sept. 14 presentation addresses the systematic study of the impact of logistics decisions on the integrity of critical biomarkers and active clinical product and data generation.

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