Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck

17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...

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EMA publishes agenda for 16-19 CHMP meeting

13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Biosimilar and interchangeable: inseparable scientific concepts?

4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration

9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...

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European Commission approves Roche’s new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer

6 September 2019 - Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival ...

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European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer

6 September 2019 - Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved by ...

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Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer

6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...

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European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma

4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination ...

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European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union

4 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission has approved the ...

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Added therapeutic benefit and drug licensing

3 September 2019 - One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs ...

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La Jolla Pharmaceutical receives European Commission approval for Giapreza (angiotensin II)

29 August 2019 - La Jolla Pharmaceutical Company today announced that the European Commission has approved Giapreza (angiotensin II) for ...

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EMA offers edits on FDA draft guidance on biosimilars

29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...

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European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer

29 August 2019 - Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people ...

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European Commission approves Soliris (eculizumab) for the treatment of adults with neuromyelitis optica spectrum disorder

27 August 2019 - 98% of adult anti-aquaporin-4 antibody-positive patients treated with Soliris were relapse free compared to 63% receiving placebo ...

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