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Top Stories
Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company's new biosimilar infringed on its Remicade patents.
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CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
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VIDEO
Pharmaceutical Technology sat down with Mike Valazza, vice-president of business development, Catalent Pharma Solutions to discuss modified-release formulations.
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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling.
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Industry News
The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.
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The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.
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Supplier News
The compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.
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The company installed the FlexFactory to support its biosimilar production.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Bio/Pharma News
The agency's Committee for Medicinal Products for Human Use recommended AstraZeneca's brodalumab for the treatment of moderate-to-severe plaque psoriasis.
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Ablynx will receive EUR15 million in milestone payment following Merck's decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.
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Regulatory News
The agency released several new and revised guidance documents regarding product-specific generic drug development.
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FDA cited the facility for violations of quality management and data integrity CGMPs.
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OUTSOURCING
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
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GMPS
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
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MANUFACTURING
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
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STANDARDS & REGULATIONS
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician's reimbursement will be based on patient outcomes.
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Events
June 12, 2017
June 19–22, 2017
July 13–14, 2017
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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