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Pharma Industry Regulation - Articles and news items

Yusen Logistics

Yusen Logistics Indonesia acquires highest standard of quality certification for pharmaceuticals transportation

Supplier news / 23 August 2016 / Yusen Logistics

T Yusen Logistics Indonesia has become the first logistics business in Indonesia to acquire GDP certification…

Pharmaceutical Packaging in-depth focus 2016

Pharmaceutical Packaging: In-Depth Focus 2016

Issue 3 2016, Manufacturing & Packaging, Supplements, Z Homepage promo / 30 June 2016 / European Pharmaceutical Review

Featuring: End-to-end verification of the medicines supply chain; Understanding the financial implications of the upcoming falsified medicines regulations; Point of view on the evolution of labelling and packaging.

Pharma sector a target for antitrust enforcers

Regulatory Insight: Pharma sector – long a target for antitrust enforcers

Issue 3 2016 / 30 June 2016 / Diarmuid Ryan and Martin Rees, Squire Patton Boggs

Many features of the pharmaceutical sector make it prone to antitrust scrutiny. Intellectual property rights, in particular patents, and the promise of monopoly rents while patents remain valid, play a crucial role in incentivising new product research and development. On the other hand, the European Commission and the various national competition authorities throughout the EU, including the UK Competition and Markets Authority’s (CMA), have applied the EU competition rules to break down barriers to trade between EU countries (a particular obsession of the Commission, given its overriding single market agenda). The rules are also designed to ensure anticompetitive agreements and concerted practices and abusive strategies are not allowed to unduly prevent or delay generic producers from bringing competitive pressure to bear on originators, and to ensure that the business practices of dominant originators do not cross the line into abusive exploitation of customers or abusive exclusion of rivals…

type 2 diabetes

EMDAC recommends NDA approval for Sanofi’s type 2 diabetes treatment

Industry news / 26 May 2016 / Victoria White, Digital Content Producer

The FDA’s EMDAC has recommended the approval of the NDA for the fixed-ratio combination of insulin glargine and lixisenatide…

CEIV Pharma: Industry cooperation that is taking off

CEIV Pharma: Industry cooperation that is taking off

Issue 2 2016, Manufacturing & Packaging / 4 May 2016 / Ricardo Aitken and Michal Wielgus, IATA Consulting

Several air transport industry stakeholders and regulators have joined forces to create the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) programme. This joint effort aims to effectively help reverse the current lack of standardisation, compliance and transparency currently afflicting the pharmaceutical air transport supply chain, via mutual cooperation, honest sharing of data and a strong emphasis on accountability…


RedHill Biopharma announces positive FDA meeting on RHB-105

Industry news / 21 April 2016 / Victoria White, Digital Content Producer

RedHill Biopharma has concluded a positive Type B Meeting with the FDA regarding the path to marketing approval of RHB-105…


EC approves Opdivo in NSCLC and advanced kidney cancer

Industry news / 14 April 2016 / Victoria White, Digital Content Producer

The EC has granted approval for the use of Opdivo (nivolumab) to treat patients with the most common forms of advanced lung and advanced kidney cancer…


SMC accepts three new medicines for use by NHS Scotland; rejects two

Industry news / 12 April 2016 / Victoria White, Digital Content Producer

Everolimus for advanced breast cancer, savuconazole for invasive aspergillosis and mucormycosis, and camellia sinensis for genital warts were all accepted…

Caroline Richards

A few words from the editor of European Pharmaceutical Review

Blog / 12 April 2016 / Caroline Richards, Editor, European Pharmaceutical Review

Here, Caroline Richards, Editor of European Pharmaceutical Review, discusses the publication and the opportunities available to authors…


EC grants marketing authorisation to afatinib in SqCC of the lung

Industry news / 7 April 2016 / Victoria White, Digital Content Producer

Afatinib is approved for the treatment of patients whose disease has progressed on or after treatment with platinum-based chemotherapy…


EU approval for Revolade for paediatric patients with chronic ITP

Industry news / 7 April 2016 / Victoria White

The approval includes the use of a new oral suspension formulation of Revolade designed for younger children who may not be able to swallow tablets…


EC expands use of Opdivo in NSCLC and approves its use in advanced RCC

Industry news / 6 April 2016 / Victoria White

The EC has approved Opdivo (nivolumab) for locally advanced or metastatic NSCLC after prior chemotherapy and in advanced RCC after prior therapy…


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