Top Stories
The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.
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PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.
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Evaluate and Pharmaceutical Technology highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.
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INTERPHEX 2017 Keynote Series:
Implementing Continuous
Manufacturing for Solid-Dosage Drugs
This presentation will examine the different tactics companies are employing and their respective advantages, with a focus on small-molecule drugs.
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Connect with top suppliers to the pharma and medical device industry at PACK EXPO East in Philadelphia, February 27 to March 1, 2017. You'll discover new solutions for enhancing safety, security and quality from 400 exhibitors. Explore 100,000 nsf of packaging innovations and machinery in action. Exchange ideas with 7,000 peers. And gain insights from the Healthcare Packaging and Processing Conference.
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Industry News
The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
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The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
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Supplier News
Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.
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The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Bio/Pharma News
BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.
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The regulatory agency rejected the medication, citing various issues related to device use.
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Regulatory News
FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.
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FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
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SUPPLY CHAIN
Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.
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MANUFACTURING
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
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Events
February 27–March 2, 2017
March 5–9, 2017
March 22–24, 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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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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