Blog
RSS FeedPosted 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 23 Sep 2016
EU approves Allergan’s IBS drug
23 September 2016 - European regulators have issued approved Allergan's Truberzi, giving patients potential access to the first approved treatment for ...
Posted by Michael Wonder on 21 Sep 2016
Recommendations on eligibility to PRIME scheme
21 September 2016 - During its September 2016 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 2 were ...
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 17 Sep 2016
Takeda receives positive CHMP opinion for conditional approval of Ninlaro (ixazomib), the first oral proteasome inhibitor, for use in patients with multiple myeloma
16 September 2016 - If authorised, Ninlaro will provide a new treatment option for European patients with multiple myeloma who have ...
Posted by Michael Wonder on 17 Sep 2016
Amgen receives positive CHMP opinion for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis
16 September 2016 - Novel treatment administered intravenously would put delivery of important therapy in the hands of the health care ...
Posted by Michael Wonder on 17 Sep 2016
Pfizer receives positive CHMP opinion for Ibrance (palbociclib) in combination with endocrine therapy for the treatment of HR+/HER2-metastatic breast cancer in Europe
16 September 2016 - If approved, Ibrance would be the first medicine in a new class of anti-cancer treatments, cyclin-dependent ...
Posted by Michael Wonder on 17 Sep 2016
New treatment for breast cancer
16 September 2016 - Ibrance provides novel treatment option for women with advanced or metastatic disease. ...
Posted by Michael Wonder on 17 Sep 2016
CHMP recommends approval of Lilly's olaratumab, in combination with doxorubicin, for advanced soft tissue sarcoma
16 September 2016 - Positive opinion is the first global regulatory step towards approval for olaratumab. ...
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 15 Sep 2016
Eisai receives license for new indication for anti-cancer agent Kisplyx (lenvatinib mesylate) for treatment of advanced renal cell carcinoma
15 September 2016 - Eisai announced that its European regional headquarters Eisai Europe has received license from the European Commission for ...
Posted by Michael Wonder on 14 Sep 2016
Progress made in the operation of EU pharmacovigilance legislation
14 September 2016 - Stakeholders discuss achievements and future priorities. ...
Posted by Michael Wonder on 14 Sep 2016
European Commission approves Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma following VEGF-targeted therapy
14 September 2016 - Cabometyx is the first and only therapy approved in the European Union to demonstrate improved overall survival, ...
Posted by Michael Wonder on 14 Sep 2016
Denmark joins the queue for a relocated European Medicines Agency
14 September 2016 - Denmark may consider bidding for the London-based European Medicines Agency, should the U.K. go ahead with its ...