Biopharma Business

Tag "European Union"

British manufacturing industry calls on government to rethink Brexit strategy

    British manufacturing industry calls on government to rethink Brexit strategy

British manufacturers are asking the government to negotiate access to the single market and a form of customs union along with suitable transition period. The call comes from EEF, the

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NHS could lose more than 2,000 GPs through Brexit

    NHS could lose more than 2,000 GPs through Brexit

GP leaders are warning that nearly 3.5 million patients are at risk of losing their family doctor, if the status of doctors from the European Union is not protected during

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Ready, steady, go: Tightened EU medical device regulations are here

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). The next step is a transition period of three years for

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EMA and EU Member States Begin Brexit Discussions

The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the UK’s departure from the EU. On April 28, 2017, the

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May the fourth be with you: IVD Symposium to take place in Dublin

On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation. Mani Subramani, head of business support,

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EU expands use of Janssen’s Darzalex

EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least one prior therapy, when given in combination with lenalidomide and

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Novartis’ lung cancer drug combination receives EU approval

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The

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Article 50: what does it mean for the UK’s medtech sector?

Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal is on the cards. It seems that every time a

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Pfizer’s Xeljanz Authorized for Marketing in the European Union

Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for the treatment of moderate to severe active rheumatoid arthritis (RA). Pfizer Inc. announced today that the European Commission (EC)

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Coping mechanism: How businesses can deal with Brexit

Frost & Sullivan, Gary Jeffery comments on the implications of Brexit for businesses both in and out of the UK. Theresa May set out an ambitious plan of maintaining a

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MEPs criticise lack of transparency on R&D costs

Price rises in the EU stir Members of European Parliament to discuss ways to make medicines more affordable, including increasing clarity on R&D costs New medicine prices in the EU

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DIA EuroMeeting explores the road ahead for drug development in the EU and UK

29 – 31 March 2017, Glasgow, United Kingdom. DIA, (founded as the Drug Information Association) announced critical workshops to be held at the 2017 DIA EuroMeeting. The goal of the

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EMA Recommends Six Medicines for Market Approval

On Feb. 24, 2017, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for market authorization in the European Union, including an

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Mundipharma to launch Mabthera biosimilar in EU markets

Mundipharma is gearing up to launch biosimilar Truxima in seven European markets for the treatment of certain cancers and inflammatory conditions, after Celltrion bagged a regulatory approval for the drug.

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