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The week in industry: 3 September 2018

Read our round-up of some of the breaking news from the pharmaceutical industry over the past week. This week: Chi-Med wins key approval, Teva discontinues the development of laquinimod and the FDA unveils plans to advance the development of non-opioid analgesics.

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Sep 07, 2018
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This week's industry news: 

FDA to take additional steps to foster the development of non-opioid pain treatments
Chi-Med wins key approval; boost for ‘made in China’ medicine
Teva to halt development of laquinimod after clinical trial failures
Historic fluorine discovery could impact pharma development

FDA to take additional steps to foster the development of non-opioid pain treatments

The US FDA has announced that it will take additional steps to advance the development of non-opioid pain treatments. FDA Commissioner Scott Gottlieb stated the agency intends to replace the 2014 guidance with new documents to “create a more efficient path for product innovation,” aiming to provide guidance to drugmakers in the development of non-opioid analgesics.

"I don't want to look back 10 years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of [the opioid] crisis," Gottlieb remarked.

Read more.

Chi-Med wins key approval; boost for ‘made in China’ medicines

China’s National Medical Products Administration has approved Hutchinson China MediTech’s (Chi-Med; Hong Kong) Elunate (fruquintinib), indicated for the treatment of metastatic colorectal cancer in patients where at least two prior systemic antineoplastic therapies have failed. The VEGFR inhibitor is to be launched in conjunction with Eli Lilly (IN, USA).

"The first home-grown, China-discovered and developed drug...to be unconditionally approved through a randomized clinical trial in China."

Chairman of Chi-Med, Simon To, commented, "Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomized clinical trial in China."

The approval is based on results from the late-stage FRESCO trial that suggest Elunate significantly improves survival versus placebo.

Read more.

Teva to halt development of laquinimod after clinical trial failures

Teva Pharmaceutical Industries (Petah Tikva, Israel) have announced the discontinuation of the development of laquinimod, with all rights reverting to partner Active Biotech (Lund, Sweden). The decision comes after multiple clinical trials missed their primary endpoints, including, the mid-stage LEGATO-HD trial for Huntington’s disease this year and the Phase III CONCERTO trial for relapse-remitting multiple sclerosis in 2017.

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Historic fluorine discovery could impact pharma development

Chemists at The University of Texas at San Antonio (TX, USA) have demonstrated the cleavage of a modified cysteine dioxygenase carbon-fluorine bond through oxidation in proteins. These results suggest it might be possible for human bodies to break carbon-fluorine bonds, present in pharmaceuticals to stabilize drugs and improve their biological activity.

"That the carbon-fluorine is strongly resistant to cleavage is a long-held belief in medicinal chemistry. Professor Liu's discovery changes that."

"This is an important discovery. More than 20 percent of pharmaceutical drugs contain fluorine," remarked Michael Doyle, the Rita and John Feik Distinguished University Chair in Medicinal Chemistry at The University of Texas at San Antonio.

"Because of their strength, fluorine-carbon bonds resist normal drug metabolism and can extend the beneficial lifetime of the drug in the body. Fluorine in drug molecules can also increase their ability to cross membrane barriers and enter cells. That the carbon-fluorine is strongly resistant to cleavage is a long-held belief in medicinal chemistry. Professor Liu's discovery changes that."

Read more.

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