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Top Stories
Novartis' Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie's Humira (adalimumab).
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The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
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Industry News
A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.
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According to CPhI's annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.
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Supplier News
The company's planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.
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The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.
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Bio/Pharma News
Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).
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Amgen's biosimilar to AbbVie's Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.
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Regulatory News
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
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The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
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This white paper is addressed to interested parties from pharmaceutical method development, validation and QC, and covers topics including:
- What are relative response factors?
- When and how do you set them up?
- What are the limitations of relative response factors?
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FINISHED PRODUCT ANALYSIS
In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide.
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PARENTERALS
Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.  Learn More |
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ANALYTICS
Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.
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Events
November 1–2, 2018
November 4–7, 2018
November 28–29, 2018
more events |
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AAPS PharmSci 360 Exhibitor Preview
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AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Drug Discovery, Development, Analytical Services, API Manufacturing, and Drug Product.
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APRECIA partners with pharmaceutical companies to bring innovative, commercial scale 3DP manufacturing capabilities to their existing product portfolios and research pipelines.
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Avista Pharma offers a broad suite of scientifically differentiated services ranging from early stage discovery, API and drug product development and cGMP manufacturing to stand-alone analytical and microbiology testing support.
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Catalent Pharma Solutions offers its partners end-to-end solutions, from drug formulation and drug delivery technologies, to manufacturing and clinical supply services.
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Chemic Laboratories, Inc. is a full-service cGMP/GLP contract analytical chemistry laboratory.
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eBOOKS
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This ebook covers 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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