In September 2017, the US FDA made public a draft industry guideline entitled “Statistical Approaches to Evaluate Analytical Similarity.” Its aim was to provide advice, to sponsors developing biosimilar agents, on how to demonstrate that the product under investigation is “highly similar” to the referenced biological. After taking into consideration the public comments relating to the document, the FDA withdrew the guideline in June 2018 for further evaluation and development to ensure that the scientific and regulatory issues that had been raised would be appropriately addressed. Continue reading “FDA to revisit guidelines for biosimilar development pathway”
In May 2018, anlotinib (Focus V®), co-developed by Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories, received its first global approval in China as a single drug therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. Continue reading “Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC”
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, based on the development milestones tracked in AdisInsight. Continue reading “Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding”
Between March 2017 and January 2018 Dupilumab was approved in four major global regions: the US, the EU, Canada, and Japan. Continue reading “Dupilumab (Dupixent®): NICE Publishes Positive Final Appraisal Determination”
The recent first global approval of fostamatinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP”
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?”
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.
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.
Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA); this was followed shortly after by an approval in Japan in July of the same year. Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018. Continue reading “Baricitinib (Olumiant™): Now also available in the USA”
The recent first global approval of Ibalizumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
Ibalizumab (Trogarzo™) developed by TaiMed Biologics received its first global approval in March 2018 in the US for the treatment of heavily treatment-experienced patients with multidrug resistant HIV-1 infection in combination with other antiretroviral medicines. Continue reading “Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection”
Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018. Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA). Continue reading “Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU”