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Strengthened guidance on follow-up and risk management for ATMP developers europeanpharmaceuticalreview
April 29, 2019
Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation…
Celgene receives positive CHMP opinion for lenalidomide and pomalidomide for multiple myeloma patients biospectrumasia
April 02, 2019
The committee also recommended approval of IMNOVID in combination with bortezomib and dexamethasone (PVd)……
Bluebird’s Zynteglo kicks off first Amsterdam CHMP recommendations pharmatimes
April 02, 2019
The first Amsterdam-based European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) meeting has been held, resulting in just one new initial marketing authorisation and three label extensions.
Mundipharma’s Neulasta biosimilar approved in EU pharmaphorum
March 07, 2019
A second cut-price biosimilar of Amgen’s Neulasta (pegfilgrastim) long-acting white blood cell booster is to hit the EU market after the European Commission approved Mundipharma’s Pelmeg.
Keytruda could get patient-friendly 6 week dosing schedule in EU pharmaphorum
March 07, 2019
US-based Merck & Co is putting further pressure on its arch-rival Bristol-Myers Squibb with a potential new six-week dosing schedule for some European patients taking its Keytruda (pembrolizumab) cancer immunotherapy.
EMA’s CHMP meeting recommends eight medicines for approval pharmaceutical-technology
March 05, 2019
The European Medical Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight medicines for approval at its February meeting...
Dengvaxia Vaccine Approved for Prevention of Dengue in Europe americanpharmaceuticalreview
December 20, 2018
The European Commission has granted marketing authorization for Dengvaxia, Sanofi's dengue vaccine. The marketing authorization follows the October 18, 2018......
Novartis withdraw marketing application for heart drug pharmafile
December 18, 2018
Swiss multinational Novartis has withdrawn a European Medicines Agency (EMA) marketing application for canakinumab for the prevention of serious events such as stroke, myocardial infarction (MI) or death in patients who have had an MI.
CHMP approve Bristol-Myers Squibb's Sprycel for paediatric patients with Ph+ ALL pharmafile
December 18, 2018
New Jersey-based firm Bristol -Myers Squibb today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the expanded approval of Sprycel...
Seven medicines leap closer to EU approval pharmatimes
December 18, 2018
The European Medicines Agency’s human medicines committee (CHMP) has put forward seven medicines for approval in the region.

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