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Top Stories
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
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The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.
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Industry News
Nemera has acquired a healthcare focused design and innovation consulting firm in Chicago, IL, Insight Product Development, strengthening its presence in North America.
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Exscientia has revealed that Sanofi will be advancing an innovative bispecific small-molecule project that was discovered through the companies' modality collaboration.
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Supplier News
The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.
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Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.
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Bio/Pharma News
RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA
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The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.
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Regulatory News
FDA has approved Roche's new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.
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The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.
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ANALYTICS
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
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CGMPS
Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
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SUPPLY CHAIN
As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
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REGULATORY/GMP COMPLIANCE
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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New Products and Services
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Catalent offers its partners end-to-end solutions, from early drug product development, formulation, and drug delivery technologies, to manufacturing and clinical supply services.
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Cambrex is the leading small-molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle.
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Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide.
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UPCOMING WEBCASTS
Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
Tuesday, September 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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From Basics to Best Practices: Exploring Bioassays and Binding Assays
Thursday, September 19, 2019 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Considerations in Primary Packaging Component Selection for Parenteral Drug Delivery
Tuesday, September 17, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIs
Thursday, September 12, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery"
Wednesday, September 11, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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