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Drugs Approvals and Trials

New research to offer blueprint for oral drug delivery

Scientists are working to develop a blueprint for a new generation of nanomedicines that could soon make it possible for patients to ...

FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. ...

To produce biopharmaceuticals on demand, just add water

Freeze-dried cellular components can be rehydrated to churn out useful proteins. ... Full story

Calls for greater transparency in the release of clinical trial data

Researchers have called for greater transparency in the public release of clinical trial data after a study revealed significant under-reporting of side effects in medical treatments. ... Full story

New Big Data Approach Predicts Drug Toxicity in Humans

Researchers can now predict the odds of experimental drugs succeeding in clinical trials, thanks to a new data-driven approach developed by Weill Cornell Medicine scientists. The method detects toxic side effects that may disqualify drugs from human use, giving drug developers an early warning before initiating clinical trials, according to a new study published Sept. 15 in Cell Chemical Biology. ... Full story

Molecular Flexibility Shown to Help Pharmaceutical Drugs Bind to Their Targets

Breakthrough could open up new directon when designing pharmaceutical drugs ... Full story

‘Generic’ Biologic Drugs Appear Comparable to Brand-Name Counterparts

New analysis suggests common and costly medications made from living cells can be equivalent even when manufactured by different company ... Full story

Proposals to revise guidance on first-in-human clinical trials

Comments invited on a concept paper on changes intended to support best practices The European Medicines Agency (EMA), in cooperation with the European Commission and the ... Full story

New genetic research can significantly improve drug development

With drug development costs topping $1.2bn (£850 million) to get a single treatment to the point it can be sold and used in the clinic, could genetic analysis save hundreds of millions of dollars? ... Full story

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