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Regulatory submissions made for dispersible formulation of dolutegravir
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
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European Medicines Agency (EMA)
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EMA recommends five drugs for approval after December meeting
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
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EMA update: non-EU metformin medicines contain acceptable levels of NDMA
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
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Zotiraciclib granted Orphan Drug Designation by FDA and EMA
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
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The Brexit test: protecting pharmaceutical quality standards through better analysis
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.
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Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
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Defining the ‘New World Order’ of supply chain security
Now that prominent compliance deadlines are nearing in the US, Saudi Arabia and Russia and with the Falsified Medicines Directive (FMD) now in force in Europe, what is going on around the world with serialisation? Allan Bowyer provides a rundown of current events and shares insights into the challenges businesses…
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EMA announces medicine approval recommendations from November meeting
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.
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Marketing Authorisation Application validated for cystic fibrosis treatment
The application was supported by positive results from two global Phase III studies in people with cystic fibrosis aged 12 and older.
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‘Revolutionary’ liquid sickle cell treatment has been unveiled
A new liquid formulation of hydroxycarbamide to treat sickle cell disease will “enable doctors to personalise doses in children".
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Sanofi announces voluntary recall of Zantac products
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
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First non-injectable treatment for severe hypoglycaemia recommended
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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EMA CHMP recommends seven medicines for approval
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
