Delivery formulations

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

By Dan Stanton

The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).

Anti-addiction formulation of super-strong opioid unclear

Anti-addiction formulation of super-strong opioid unclear

By Fiona Barry

Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation...

Europe slow to adopt anti-abuse formulations and tech, says expert

Europe slow to adopt anti-abuse formulations and tech, says expert

By Fiona Barry

European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.

NIH partners with 10 pharma companies to tackle major disease targets

NIH partners with 10 pharma companies to tackle major disease targets

By Zachary Brennan

The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.

Complex generics will boost speciality biz, Teva says

Complex generics will boost speciality biz, Teva says

By Dan Stanton

Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.

APL says 'specials' biz benefits CMO offering

APL says 'specials' biz benefits CMO offering

By Gareth Macdonald

Apotek Produktion & Laboratorier AB (APL) says manufacturing knowledge and drug delivery tech knowhow gained by its compounding business is a boon for its CMO unit.

Unregistered vs fake - How terminology sparked a media war in Ghana

Unregistered vs fake - How terminology sparked a media war in Ghana

By Dan Stanton

In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes...

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