Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe

In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells, and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. [1] Continue reading “Durvalumab (Imfinzi®): CHMP Positive Opinion for NSCLC in Europe”

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®) was approved by the Japanese Ministry of Health, Labour and Welfare in July 2018, for maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan”

Call for Papers: Themed Issue – Improving Transparency in Decision Models

Call for Papers: Themed Issue – Improving Transparency in Decision Models

PharmacoEconomics invites the submission of papers (original research, reviews and opinion pieces) on improving transparency in decision models for a themed issue of the journal to be published in 2019 and guest edited by Paul Tappenden (University of Sheffield) and Jaime Caro (London School of Economics and McGill University). We encourage papers from the perspectives of a variety of stakeholders including methodologists, payers, health technology assessment bodies, analysts, pharmaceutical industry, advocacy groups and software developers. Country-specific perspectives are also encouraged. Papers can be either methodological or applied.  Continue reading “Call for Papers: Themed Issue – Improving Transparency in Decision Models”

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

The recent first global approval of andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo] has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding”

Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP

Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP

The recent first global approval of fostamatinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP”

Bioengineered bacteria… the answer to a broken biome?

Bioengineered bacteria… the answer to a broken biome?

In the good old days eating mud pies and sucking on worms in the garden was considered a normal part of growing up. Maybe not worthy of a Michelin star, and maybe some would be worried about “germs”, but who knew back then that we would eventually be actively exploring how to re-invent bacteria to help treat diseases, particularly those associated with malfunctions of the microbiome: the collective genes of the community of microorganisms our bodies play happy host to. Continue reading “Bioengineered bacteria… the answer to a broken biome?”

Call for Papers: Special Issue – The Economics of Mental Health

Call for Papers: Special Issue – The Economics of Mental Health

Applied Health Economics and Health Policy invites the submission of manuscripts with a focus on the economics of mental health for a special issue of the journal to be published in 2019.

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Impact Factor: 1.89

Estimates suggest that the annual cost of mental illness to developed countries is around 4% of GDP and results in around 12 million days of reduced productivity each year. To further our understanding of these issues, Applied Health Economics and Health Policy is calling for papers that explore the economic dimensions of mental health. Some key questions this work may consider include:

  • Are resources allocated efficiently in mental health?
  • What is the economic cost of mental illness?
  • What would be the return on investment of a scaled-up response to the burden of mental ill health?

The Guest Editors for the special issue are Professor Chris Doran and Dr Irina Kinchin from Central Queensland University, Australia.

Please submit an abstract describing your proposed paper by 30 September 2018 to the Editor, Tim Wrightson. Full papers will be invited by 31 October 2018 with manuscripts due in March 2019.