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RSS FeedPosted by Michael Wonder on 22 Apr 2017
Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
21 April 2017 - Subject to EC approval, Sandoz market leadership position extended as the only company to have five approved ...
Posted by Michael Wonder on 22 Apr 2017
BioMarin receives positive CHMP opinion in Europe for Brineura (cerliponase alfa) for first treatment of CLN2 disease, a form of Batten disease and ultra-rare and fatal brain disorder in children
21 April 2017 - One of the first therapies to receive positive CHMP opinion using new accelerated assessment process decision ...
Posted by Michael Wonder on 22 Apr 2017
Biogen’s Spinraza (nusinersen) receives positive CHMP opinion for the treatment of spinal muscular atrophy
21 April 2017 - First SMA treatment recommended for approval in the EU. ...
Posted by Michael Wonder on 22 Apr 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
21 April 2017 - First positive CHMP opinion for an immuno-oncology agent for patients with locally advanced or metastatic urothelial cancer. ...
Posted by Michael Wonder on 20 Apr 2017
Ipsen in talks with NICE over Cabometyx rejection
20 April 2017 - Ipsen says discussions with NICE are ongoing following a second rejection of Cabometyx for advanced renal ...
Posted by Michael Wonder on 20 Apr 2017
CADTH recommends Kevzara
18 April 2017 - Sarilumab was approved by Health Canada on 12 Jan 2017 for the treatment of adult patients ...
Posted by Michael Wonder on 20 Apr 2017
Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment
19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of ...
Posted by Michael Wonder on 19 Apr 2017
NICE nod for Novartis’ Cosentyx in psoriatic arthritis
19 April 2017 - NICE has published a positive Final Appraisal Determination which backs NHS use of Novartis’ Cosentyx (secukinumab) ...
Posted by Michael Wonder on 19 Apr 2017
NICE publishes second appraisal consultation document for cabozantinib maleate
19 April 2017 - The Department of Health has asked NICE to produce guidance on the use of cabozantinib in the ...
Posted by Michael Wonder on 19 Apr 2017
Health Canada approves Tecentriq (atezolizumab) for patients with locally advanced and metastatic bladder cancer
18 April 2017 - Early data suggests Tecentriq shows strong efficacy for metastatic bladder cancer patients, offering the first new ...
Posted by Michael Wonder on 19 Apr 2017
PHARMAC reject request to fund women's hygiene products
19 April 2017 - The government's drug-buying agency has rejected a request to fund women's hygiene products. ...
Posted by Michael Wonder on 18 Apr 2017
FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer
18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...
Posted by Michael Wonder on 18 Apr 2017
Submissions received and TGA response: orphan drug program
18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 18 Apr 2017
Janssen receives Health Canada approval of Darzalex (daratumumab) by priority review for patients with multiple myeloma who have had at least one prior therapy
17 April 2017 - Darzalex combination therapy significantly improved progression-free survival compared to standard of care regimens alone. ...
Posted by Michael Wonder on 18 Apr 2017
FDA approves Genentech’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States
17 April 2017 - Granted priority review designation by the FDA based on analysis of results from a National Institutes of ...