DESPITE the US Food and Drug
Administration (FDA) making
strides in incentivising companies
to develop antimicrobial therapies,
GlobalData market research firm
has said it believes the agency
needs to continue taking proactive
action if it is to keep pace with
progressive regulatory bodies in
the EU, particularly the European
Medicines Agency (EMA).
Marc C. Hansel, GlobalData’s
analyst covering infectious
diseases, said a number of unmet
needs remain within the bacterial
infectious diseases area, with
novel treatments for multidrugresistant
gram-negative bacteria in
particularly high demand.
Hansel said the EMA had shown
superior willingness to reform
clinical trial design for novel
antibiotics and provide guidance
that prioritises clinical feasibility.The above article was sent to subscribers in Pharmacy Daily's issue from 17 Jul 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 17 Jul 14
MONTU Group, its subsidiary Alternaleaf Pty Ltd, and their common director Christopher Strauch are facing legal action by the Therapeutic Goods Administration (TGA) in the Federal Court of Australia for alleged unlawful advertising on the effectiveness of their medicinal cannabis products.
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