When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and Drug Administration (FDA) has special programs available to expedite its clinical testing and approval. One is the "Accelerated Approval" pathway, in which the FDA will accept weaker-than-usual evidence of the drug's efficacy from its pre-clinical trials. In exchange, the FDA requires that the manufacturer conduct post-approval confirmatory studies....
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Janney Montgomery Scott restated their buy rating on shares of West Pharmaceutical Services Inc. (NYSE:WST) in a report released on Friday morning. Other equities research analysts have also recently issued research reports about the stock. Zacks Investment Research upgraded shares of West Pharmaceutical Services from a sell rating to a hold rating in a research note on Thursday, December 15th…...
THE CERBAT GEM
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AstraZeneca’s biologic Fasenra has picked up its first global approval in the US as a treatment for severe, eosinophilic asthma, a difficult to treat a form of the condition....
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Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement following the passage of the 21st Century Cures Act in the House of Representatives: “PhRMA applauds the House of Representatives for passing the bipartisan 21st Century Cures Act to improve the discovery and development of new medicines for patients. The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and...
PHRMA.ORG
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The pharmaceutical industry is New Jersey’s perennial list topper when it comes to measuring what drives the state’s economy, but logistics is never far behind. And, just as often in the Garden State, the two go hand-in-hand. Besides the state’s higher-than-average concentration of drug-dedicated third-party logistics providers, there are a number of little-known players generating big business at the intersection between the pharmaceutical and logistics sectors. It’s par...
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Ever since the government has introduced online system to track imports of drugs at ports a couple of years ago, the online system named Icegate system has been marred by procedural flaws leading to its poor implementation which has badly impacted the industry. It is learnt that after two years of its introduction, the system is not completely online and the bill of entries are being accepted off line too leading to delays, inconsistent decisions and poor tracking of data related to drugs. This ...
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