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RSS FeedPosted by Michael Wonder on 29 Jun 2016
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
29 June 2016 - The U.S. FDA today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests ...
Posted by Michael Wonder on 29 Jun 2016
FDA approves implantable device that changes the shape of the cornea to correct near vision
29 June 2016 - The U.S. FDA today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the ...
Posted by Michael Wonder on 29 Jun 2016
Ibrutinib (Imbruvica) granted breakthrough therapy designation by U.S. FDA for the development of a treatment for chronic graft-versus-host disease
29 June 2016 - In current clinical practice, there are no FDA-approved treatments for this life-threatening condition. ...
Posted by Michael Wonder on 29 Jun 2016
New antibiotic Zavicefta approved in the European Union for patients with serious bacterial infections
28 June 2016 - AstraZeneca today announced that the European Commission has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as ...
Posted by Michael Wonder on 28 Jun 2016
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
28 June 2016 - The U.S. FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with ...
Posted by Michael Wonder on 27 Jun 2016
Health Canada approves first treatment for schizophrenia dosed four times a year
27 June 2016 - 93% of patients treated with Invega Trinza remained relapse-free at the end of long-term relapse prevention trial. ...
Posted by Michael Wonder on 26 Jun 2016
Teva receives CHMP positive opinion for Cinqaero (reslizumab)
24 June 2016 - Add-on therapy targeting IL-5 in adults with severe eosinophilic asthma pending marketing authorization in Europe. ...
Posted by Michael Wonder on 26 Jun 2016
MolMed receives positive CHMP opinion recommending conditional marketing authorisation for Zalmoxis, the first immunogene therapy to treat high-risk haematological malignancies in patients receiving haplo-identical haematopoietic stem cell transplantation
24 June 2016 - The CHMP of the EMA, in conjunction with the Committee for Advanced Therapies, has issued a ...
Posted by Michael Wonder on 24 Jun 2016
Highlights from the CHMP 20-23 June 2016 meeting
24 June 2016 - Six new medicines, including one cell-based therapy, recommended for approval. ...
Posted by Michael Wonder on 24 Jun 2016
New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
24 June 2016 - Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation ...
Posted by Michael Wonder on 24 Jun 2016
NICE publishes appraisal consultation for osimertinib mesylate (Tagrisso) for patients with non-small-cell lung cancer
24 June 2016 - NICE has published an appraisal consultation for AstraZeneca's Tagrisso. ...
Posted by Michael Wonder on 24 Jun 2016
Allergan announces FDA approval of supplemental new drug application for Avycaz (ceftazidime and avibactam)
23 June 2016 - Label now includes Phase 3 clinical data evaluating the safety and efficacy of Avycaz (in combination with ...
Posted by Michael Wonder on 24 Jun 2016
European Commission grants marketing authorization for Gilead’s single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV
23 June 2016 - Odefsey is the second single tablet regimen containing the Descovy backbone and the third product in Gilead’s ...
Posted by Michael Wonder on 24 Jun 2016
Health Canada issues a Notice of Compliance for Simponi as the first and only treatment indicated for non-radiographic axial spondyloarthritis
23 June 2016 - Research shows Simponi improves symptoms and physical function. ...
Posted by Michael Wonder on 23 Jun 2016
New guidance from NICE recommends Humira (adalimumab), the only licensed biologic for treatment of hidradenitis suppurativa, a debilitating and disfiguring skin condition
22 June 2016 - AbbVie today announced that the NICE has published single technology appraisal guidance for the only licensed ...