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EMAUKEU

EMA pushes its transparency initiative forward

24.02.2012 - The European Medicines Agency (EMA) will publish information about all drugs under review, beginning on March 1. On a monthly basis the company will issue a list disclosing the international non-proprietary name and therapeutic areas of each product under review as well as information on the type of salt, ester or derivative of the active ingredient.

Until now, EMA has published information just about orphan drugs under review. Information on other products will not be released until the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion. The plan is part of the agency ’s new policy on transparency and access to documents. The agency will also assume more responsibility in the field of pharmacovigilance. Up to now, the EMA focused its post-marketing drug safety monitoring on the 568 centrally authorised medicines for human use. But as of mid-July, the EU drug watchdog will stepwise include pharmacovigilance data from nationally authorised medicines. The newly formed Pharmacovigilance Risk Assessment Committee (PRAC) will be responsible for the implementation of the new European drug safety rules.

BusinessSpainUKSweden

31.07.2014 Astrazeneca is buying the rights to Almirall’s respiratory drugs in a deal worth up to €1.56bn.

BusinessFranceGermanySwitzerlandUK

30.07.2014 Rumours have it that French Danone wants to sell its medical nutrition business to US drugmaker Hospira for US$5bn in yet another tax inversion deal.

RegulationUKEU

29.07.2014 The first vaccine for malaria may be within reach: The European Medicines Agency has accepted Glaxosmithkline’s malaria vaccine candidate RTS,S for regulatory review.

FundingEU

25.07.2014 The European Commission aims to support innovation in Europe and announced a "Fast Track to Innovation" pilot as well as five innovation prices under Horizon 2020.

ResearchUKEU

23.07.2014 In the largest genomic study published on any psychiatric disorder so far, researchers have indentified 83 new locations in the human genome associated with the risk of developing schizophrenia.

BusinessUKIreland

21.07.2014 Abbvie’s tenacious pursuit of British rival Shire is finally paying off: The two companies have unveiled their transatlantic merger worth £32bn (€40bn).

ResearchEUSwitzerland

17.07.2014 A trans-border, cross-disciplinary project that aims to model the human brain in a computer has drawn heavy criticism from scientists pledging to boycott the project.

MergerUK

16.07.2014 After rejecting three merger propositions from US competitor Abbvie, Shire has now given up resistance to the deal and is recommending a new and improved offer worth £31.3bn.

AcquisitionUKDenmarkSpainGermanyFrance

15.07.2014 British specialty pharma company Prostrakan is handing over £230m for Archimedes Pharma Limited, a company that brings its lead product Pecfent and its proprietary drug delivery technology platform into the deal.

FundingEU

11.07.2014 Among the seven newly launched Joint Technology Initiatives (JTI) of Horizon2020 are two with deep roots in biotech: IMI is going into its second round while the newly established Bio-based Industries partnership invests in bioeconomy.

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No liability assumed, Date: 31.07.2014