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RSS FeedPosted by Michael Wonder on 01 Dec 2016
Coherus’ marketing authorisation application to European Medicines Agency for CHS-1701 (pegfilgrastim biosimilar candidate) accepted
29 November 2016 - Coherus BioSciences today announced acceptance of a marketing authorisation application to the EMA for CHS-1701, a ...
Posted by Michael Wonder on 27 Nov 2016
Janssen submits application to EMA seeking approval of anti-interleukin 23 monoclonal antibody guselkumab for the treatment of moderate to severe plaque psoriasis
25 November 2016 - Janssen-Cilag announced today the submission of a marketing authorisation application to the EMA seeking approval of guselkumab ...
Posted by Michael Wonder on 26 Nov 2016
GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - follows regulatory submissions in US and Canada
25 November 2016 - GlaxoSmithKline today announced the regulatory submission of a marketing authorisation application to the EMA seeking approval ...
Posted by Michael Wonder on 02 Nov 2016
Celltrion seeks EMA approval of Herceptin biosimilar
31 October 2016 - South Korean biopharma developer Celltrion said Monday that it has submitted its Herceptin biosimilar to the ...
Posted by Michael Wonder on 01 Nov 2016
European Medicines Agency validates the marketing authorization application for avelumab for the treatment of metastatic Merkel cell carcinoma
31October 2016 - If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic ...
Posted by Michael Wonder on 25 Oct 2016
EMA encourages companies to submit Type I variations for 2016 by end of November
25 October 2016 - EMA to check validity of submissions by end 2016. ...
Posted by Michael Wonder on 04 Oct 2016
Mundipharma and Orexo announce EU regulatory submission for Zubsolv
4 October 2016 - Mundipharma and Orexo make first EU regulatory submission for Zubsolv (buprenorphine and naloxone) sublingual tablet. ...
Posted by Michael Wonder on 04 Oct 2016
Samsung Bioepis seeks Europe approval for copy of Herceptin breast cancer drug
3 October 2016 - South Korea's Samsung Bioepis, a maker of cheaper copies of complex biotech drugs known as biosimilars, is ...
Posted by Michael Wonder on 26 Sep 2016
GSK announces regulatory submissions for subcutaneous formulation of Benlysta (belimumab) for patients with systemic lupus disease
23 September 2016 - GSK today announced that it has filed regulatory submissions in the US and Europe for Benlysta (belimumab) ...
Posted by Michael Wonder on 21 Sep 2016
AstraZeneca withdraws cancer drug after 'differences of opinion' with regulator
21 September 2016 - AstraZeneca has suffered a setback after being forced to withdraw an application for a key ovarian cancer ...
Posted by Michael Wonder on 20 Sep 2016
European Medicines Agency validates Bristol-Myers Squibb’s type II variation application for Opdivo (nivolumab) in advanced form of bladder cancer
20 September 2016 - Results from Phase II study CheckMate-275 evaluating Opdivo in metastatic urothelial carcinoma serve as basis for application. ...
Posted by Michael Wonder on 16 Sep 2016
BioMarin announces EMA validation of Brineura (cerliponase alfa) marketing authorization application for treatment of CLN2 disease, a form of Batten disease
15 September 2016 - CHMP opinion and EU decision expected in Q3 2017. ...
Posted by Michael Wonder on 13 Sep 2016
Janssen submits marketing authorisation application for darunavir-based single tablet regimen for treatment of HIV-1 to European Medicines Agency
12 September 2016 - Janssen today announced the submission of a Marketing Authorisation Application to the EMA, seeking approval for ...
Posted by Michael Wonder on 12 Sep 2016
GSK announces EU regulatory submission for sirukumab in rheumatoid arthritis
12 September 2016 - GSK today announced the regulatory submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 25 Aug 2016
Mylan and Biocon announce regulatory submission for proposed biosimilar trastuzumab accepted for review by European Medicines Agency
25 August 2016 - Mylan and Biocon announced today that the EMA has accepted for review Mylan's marketing authorization application ...