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Regulatory & Safety: Top Headlines

Baxter donates IVs to aid groups fighting Ebola in Africa

29-Aug-2014 - Baxter International has donated intravenous fluids to aid organisations treating Ebola infected patients in Liberia and Sierra Leone.

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News in brief

US claims Dr Reddy’s broke safety packaging rules for 4 years

28-Aug-2014 - Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 - A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Argentina to allow Indian drug imports after inspecting five plants

25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

People on the Move

People on the Move at GSK, Allergan, Novartis

25-Aug-2014 - Our weekly round-up of the bright young things and big cheeses in pharmaceuticals.

UK drug exporters shipping outside the EEA must seek MHRA approval

20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

Eisai sues FDA for ‘losing one year’ of marketing to generics rivals

20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.

Regulatory & Safety: Featured news

Spotlight

SCM's woes part of UK-wide aseptic slowdown, says ex-owner

SCM's woes part of UK-wide aseptic slowdown, says ex-owner

GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend...

Boehringer aims to cut German costs 15% as H1 sales fall

Boehringer Ingelheim aims to cut German costs 15% as revenues drop

German jobs are safe despite a programme that will cut the cost of operations by 15%, Boehringer...

WHO: Data from use of unapproved Ebola drugs should be shared

WHO: Data from use of unapproved Ebola drugs should be shared

Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an...

THC may reduce tumor size? mouse study investigates

THC may reduce tumor size? mouse study investigates

A previously unknown signaling platform may be responsible for the success of the main psychoactive ingredient in...

India’s CDSCO outlines procedures for state manufacturer inspections

India’s CDSCO outlines procedures for state inspections of manufacturers

In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control...

Roche re-enters RNAi space with $250m Santaris acquisition

Roche re-enters gene silencing space with $250m LNA acquisition

Roche has renewed its interest in gene silencing drugs, paying $250m (€187m) for Santaris Pharma including its...

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