Biopharma Business

Tag "EC"

Commission not ranking preferences for key EU agencies post-Brexit

    Commission not ranking preferences for key EU agencies post-Brexit

The publication on Saturday of the EU Commission’s unranked and unshortlisted assessment of the 27 bids from member states to host the London-based European Banking Authority (EBA) and the European

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Single-tablet regimen for HIV-1 approved by European Commission

    Single-tablet regimen for HIV-1 approved by European Commission

Janssen has announced that the European Commission (EC) has approved its darunavir-based single-tablet regimen (STR), Symtuza▼, for the treatment of HIV-1 in adults and adolescents in Europe. “Today’s decision by

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UCB receives EU approval for paediatric anti-epileptic drug

    UCB receives EU approval for paediatric anti-epileptic drug

UCB has announced that the European Commission (EC) has approved expanding the use of its anti-epileptic drug (AED) Vimpat (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset

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UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

    UK’s NICE approves Roche’s breast cancer drug Kadcyla for routine use

The UK National Institute for Health and Care Excellence (NICE) has granted approval for Roche’s breast cancer drug Kadcyla for routine use within the NHS region. NICE has recommended Kadcyla

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EC approves Johnson & Johnson’s $30bn acquisition of Actelion

    EC approves Johnson & Johnson’s $30bn acquisition of Actelion

The European Commission (EC) has approved Johnson & Johnson’s proposed $30bn acquisition of Actelion Pharmaceuticals, subject to conditions J&J signed an agreement in January this year to acquire Actelion, which develops

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Brilique (ticagrelor) new formulation gains European approval

    Brilique (ticagrelor) new formulation gains European approval

The European Commission (EC) has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new method of treatment administration. This decision means that ticagrelor will become the

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Biogen Wins Full EC Approval for MS Drug Fampyra

    Biogen Wins Full EC Approval for MS Drug Fampyra

The EC granted full marketing approval for Biogen’s Fampyra® (prolonged-release fampridine) as a treatment to improve walking in people with multiple sclerosis (MS). Clearance in Europe was based on the

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Aspen Pharmacare hit by EU antitrust cancer drug price probe

    Aspen Pharmacare hit by EU antitrust cancer drug price probe

  Aspen Pharmacare is under investigation by the European Commission over its pricing practices for five cancer medicines. EU antitrust regulators will investigate whether the South African generics firm abused

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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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