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Regulatory & Safety: Top Headlines

The end for AbbVie’s bestseller? US FDA approves Amgen’s Humira biosimilar

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26-Sep-2016 - Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.

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US FDA warns against $30 DIY alternative to Mylan's EpiPen

22-Sep-2016 - The US FDA has warned people not to use a $30 DIY epinephrine delivery device developed after Mylan increased the price of the Epipen.

Cell and gene therapy investment to continue to grow post-Brexit, CGT Catapult

21-Sep-2016 - Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012

Sarepta looks to scale up production on back of its DMD drug success

20-Sep-2016 - Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.

Shire ends pacritinib development deal with CTI post Baxalta merger

20-Sep-2016 - Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.

Pii faces EU ban following GMP issues at Maryland facilities

19-Sep-2016 - The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).

Bayer committed to pharma R&D and CapEx despite planned Monsanto buy

15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.

Teva months from restarting production at Hungary plant banned by US FDA

15-Sep-2016 - Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.

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