-
Implications of no-deal Brexit on access to medicines: industry representatives advise Lords committee
pharmaceutical
November 19, 2018
In the context of continuing failures to reach a Brexit deal and the UK Government publishing technical notices advising various sectors what to do in the event of no-deal Brexit scenario...
-
Phamaceutical trade lobby responds to Brexit deal
pharmafile
November 16, 2018
The Association of the British Pharmaceutical Industry (ABPI) has responded to Theresa May’s Brexit deal, after the government announced a 585 page draft withdrawal
-
Beximco Pharma enters EU market
biospectrumasia
November 16, 2018
Singapore: Beximco Pharmaceuticals, a manufacturer of generic pharmaceutical products and active pharmaceutical ingredients in Bangaldesh, has commenced export of its products to Europe
-
AbbVie offers up 80% Humira discount in EU tender market to hold off biosimilars: report
fiercepharma
November 02, 2018
How far is AbbVie willing to go to fend off the new Humira biosimilars in Europe? Quite far, apparently, judging by the enormous discount it offered to win a government contract.
-
EU suspends GVK Bio medicine for non-compliance
biospectrumasia
October 23, 2018
EU suspends GVK Bio medicine for non-compliance
-
Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--EU
zhulikou431
October 11, 2018
The EU has been early in conducting PV, and possesses a sound PV system which is also divided into three layers for regulation: directives, regulations, and guidelines. See the following table for the main establishment process of regulations of the EU PV
-
EU regulators blast China’s Zhejiang Huahai over valsartan API mess
fiercepharma
September 29, 2018
The European Medicines Agency has piled onto China’s Zhejiang Huahai, finding its manufacturing out of compliance for the valsartan API that has been recalled globally after being found to contain a suspected carcinogen.
-
EU green light for new Humira biosimilar
pharmatimes
September 27, 2018
The European Commission has approved Mylan and Fujifilm Kyowa Kirin Biologics’ Humira biosimiar Hulio.
-
EU approves new option for metastatic melanoma
pharmatimes
September 27, 2018
The European Commission (EC) has granted marketing authorisation for Pierre Fabre’s Braftovi and Mektovi combination therapy for the treatment of adults...
-
EU green light for new Humira biosimilar
pharmatimes
September 21, 2018
The European Commission has approved Mylan and Fujifilm Kyowa Kirin Biologics’ Humira biosimiar Hulio.