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Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
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FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
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The 2017 PDA/FDA Joint Regulatory Conference is the premier pharmaceutical manufacturing event where you can engage directly with U.S. FDA representatives! Over two and a half information-packed days, FDA regulators will provide updates on efforts affecting the development of global regulatory strategies, and industry experts will illustrating how they use global strategies to improve the quality of medical products.
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Industry News
The International Pharmaceutical Excipients Council (IPEC) has announced the winners of the 2017 award season.
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On August 3, 2017, Bristol-Myers Squibb (BMS) announced that it has agreed to acquire biotech firm, IFM Therapeutics, in a deal worth over $1 billion to develop BMS’ oncology pipeline.
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Supplier News
Charles River Labs has announced the acquisition of Brains On-Line (US), a contract research organization (CRO) that provides data on therapeutics for treating central nervous system (CNS) diseases.
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Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.
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Bio/Pharma News
The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.
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FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).
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Regulatory News
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
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Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
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40th Anniversary
FDA’s process validation process validation process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
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Facilities
Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.
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Outsourcing
Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.
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Events
August 15–16, 2017
August 16–17, 2017
August 21–25, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles from Pharmaceutical Technology designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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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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