Politics

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.

http://www.european-biotechnology-news.com/news/news/2012-01/ema-pushes-its-transparency-initiative-forward.html

PoliticsSwitzerland

23.10.2014 Just one day before its planned initial listing, Swiss Molecular Partners has cancelled its IPO. The reason: "unfavourable market conditions".

PoliticsEU

23.10.2014 Jean-Claude Juncker can breathe a sigh of relief as MEPs voted “yes” by a large majority to his team of European Union Commissioners. Previous to the vote, Juncker had shifted the EMA back to the health commissioner in response to protests.

FinancingFrance

21.10.2014 Yet another European company is looking for money on the US stock exchange – French DBV Technologies SA is all set up for its secondary listing on NASDAQ. The French biotech company hopes to rake in US$98m for its peanut allergy patches.

FinancingDenmark

18.10.2014 After raising US$220.5m (€172m) with its IPO, fast Forward Pharma’s lucky streak hits an obstacle on the road to success with shares falling 17% on its first day of trading.

M&AUKItaly

17.10.2014 Abandoned at the altar: Abbvie has dropped plans to acquire UK’s Shire following new US tax rules. This puts a stop to one of the biggest pharma mergers planned this year.

FinancingUKBelgium

15.10.2014 Bicycle Therapeutics wins €25m backing by major pharma venture capitalists for the development of a new class of oncology drugs.

FinancingGermanySwitzerlandNetherlands

13.10.2014 Biotechnology IPOs are back in fashion – German Probiodrug AG wants to raise €32m with its IPO, whilst Swiss Molecular Partners AG hopes the launch of its IPO will gain a revenue of €145m.

BusinessIreland

10.10.2014 Actavis has announced plans to merge with American pharma company Durata - a move that will strengthen their infectious diseases portfolio.

RegulationEU

07.10.2014 In an unprecedented move, the European Medicines Agency has approved a system allowing the future analysis of clinical trial data.

FinanceNetherlandsEU

06.10.2014 Another fund from the Netherlands has raised €92m in its first close and will invest the money in companies developing innovative therapeutics, medical devices and diagnostics.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • VITA 344.32 EUR6.67%
  • MORPHOSYS74.44 EUR4.04%
  • STRATEC BIOMEDICAL39.84 EUR3.94%

FLOP

  • CYTOS0.16 CHF-5.88%
  • CO.DON2.75 EUR-3.17%
  • ADDEX3.30 CHF-2.94%

TOP

  • BIOFRONTERA2.90 EUR31.2%
  • VITA 344.32 EUR8.0%
  • BB BIOTECH157.70 EUR7.3%

FLOP

  • PAION2.24 EUR-30.0%
  • CYTOS0.16 CHF-27.3%
  • MAGFORCE5.90 EUR-17.5%

TOP

  • SANTHERA85.50 CHF2335.9%
  • CO.DON2.75 EUR192.6%
  • PAION2.24 EUR163.5%

FLOP

  • CYTOS0.16 CHF-95.8%
  • THERAMETRICS0.08 CHF-42.9%
  • 4SC0.97 EUR-42.6%

No liability assumed, Date: 23.10.2014