Improving Manufacturing Efficiency Requires Regulatory Reform
CPhI expert, Girish Malhotra, warns that without urgent regulatory reform, the industry would remain reluctant to make process changes that will improve manufacturing efficiency due to the financial...
View ArticleFDA Promotes Its Scientific Mission
In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.Date:...
View ArticleHow Clinton's Drug Plan Could Give Manufacturers Even More Pricing Power
Although the presidential candidate seeks to cap monthly drug costs to $250 for covered drugs, what will happen to drug costs that are associated with co-insurance?Date: Thu, 2015-09-24 (All...
View ArticleEvolving to Meet Industry Changes
In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.Date: Fri, 2015-10-02 (All day)Publish Start Date: Mon, 2015-10-05 (All day)Article sort author:...
View ArticlePharma Can Learn from US Auto Industry
A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.Date: Tue, 2015-10-13...
View ArticleMega Trade Pacts Impact Pharmaceutical Markets
A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.Date: Tue, 2015-10-13 (All...
View ArticleBiosimilar Development Continues to Challenge FDA and Industry
Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex...
View ArticleHow to Give Pharma’s Culture a Collaborative Shot in the Arm
Everyone talks about “open innovation,” but without the right working culture it won’t succeed. MeetingZone’s Anthony Prior explains how unified communications can help kick-start the necessary...
View ArticlePharma Trends—From Biologics for Niche Patient Populations to Isolators and...
Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from...
View ArticleHard Times in Washington for Generic Drugs
Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit...
View ArticleModernizing Oral Solid-Dosage Manufacturing
Experts at the ISPE annual meeting describe best practices, including containment and production in classified spaces.Date: Wed, 2015-11-18 (All day)Article sort author:...
View ArticleCaliff Sidesteps Drug Pricing Complaints from Senate
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.Date: Wed, 2015-11-18 (All day)Article sort author:...
View ArticleFDA Seeks Industry Support for Quality Metrics
FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.Date: Mon, 2015-11-23 (All day)read more
View ArticleThe $3.5-Billion Pharmaceutical Prenup
Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.Date: Tue,...
View ArticleEmerging Markets—An Opportunity for Pharma to Drive Sustainable Growth
Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an...
View ArticleRemembering Pedro Hernandez Abad’s Rich Legacy
This month marks the death of a pragmatic, original thinker who helped make PAT and QbD a reality at more pharmaceutical facilities throughout the world.Date: Mon, 2015-12-14 (All day)Article sort...
View ArticleRole of Drug Compounders Debated in Drug Pricing Probe
The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.Date: Mon, 2015-12-14 (All day)Article sort author:...
View ArticleWoodcock Lays Out Long To-Do List for CDER
Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.Date: Thu, 2015-12-17 (All day)Article sort author:...
View ArticlePriority Review Vouchers Raise Risks, say FDA Officials
The FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.Date: Mon, 2015-12-28 (All day)Article sort author:...
View ArticleEnhancing New Drug Development
More “me-betters” and more focused breakthroughs could enhance new drug development.Date: Mon, 2016-01-04 (All day)Article sort author: workspace://SpacesStore/a7cc148e-a975-4980-8701-eeb26fe534fd...
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