Search results for " healthcare"
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Labeling of Biosimilars
“A lot of stakeholders at EU level have agreed that physician perception and patient acceptance impact biosimilars uptake,” says Miriam Gargesi, EuropaBio’s healthcare director. “We believe that a new…
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Setting Standards for Biotech Therapeutics in India
Similarly, IP 2007 contained 271 new monographs with focus on those drugs and formulations that cover the National Healthcare Programs and the National List of Essential Medicines. The addendum in 200…
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Pharma Investments Reflect Key Industry Trends
Bayer HealthCare: Bayer HealthCare is making several investments at home in Germany and abroad. The company will spend nearly $694 million at existing sites in Leverkusen and Wuppertal, Germany to exp…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Drug development and regulation will never be the same following the momentous changes in healthcare delivery and biomedical research over the past year. The desperate need for new vaccines and therap…
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CDMOs Driving Emerging Bio/Pharma Success
… investors more skittish about investing and a major change in the willingness and ability of the US healthcare industry to pay for expensive new drugs. Both of these risks are real. Many economists …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
(Davis Healthcare International and Parenteral Drug Association, 2009) pp 103-121.
12. P. Lopolito, “Critical Cleaning for Pharmaceutical Applications, Chapter 17” in Handbook for Critical Clean…
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Unifying Continuous Biomanufacturing Operations
Prior to the Tiainen/Novo Nordisk patent, Bayer HealthCare was granted a patent in Europe in 2016 for the integrated continuous manufacture of biologics. The two proposed platforms in that patent, how…
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Downstream Processing for Cell-Based Therapies
The increased demand for hospital and social care, coupled with complex medical interventions, has led to spiralling costs for healthcare systems globally. Advanced therapies, including cell- and gene…
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Biosimilars: Making the Switch Comes with Challenges
Biosimilar producers, regulators, and other key groups in the European healthcare sector, however, agree that the growth rate should be higher. This view was echoed by speakers at the annual Biosimila…
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GMP Challenges for Advanced Therapy Medicinal Products
…mittee for advanced therapies (CAT), told an European Directorate for the Quality of Medicines & Healthcare (EDQM) workshop on Paving the Way for the Future—Biologicals at Strasbourg, France, in 2014…