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

R&DUKIreland

12.02.2016 The promise of the microbiome as the basis of new treatments has caught the attention of many. Now, UK biotherapeutics maker 4D pharma plc has padded its microbiome pipeline with the acquisition of Irish Tucana Health.

CommercialisationEU

10.02.2016 In future, meds will come in packages sporting a unique barcode and an anti-tampering device. These measures are part of the EU’s new regulation to safeguard against falsified medicines.

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. A preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • PAION (D)1.77 EUR63.89%
  • 4SC (D)2.95 EUR11.32%
  • BIONOR PHARMA (N)0.86 NOK8.86%

FLOP

  • STENTYS (F)2.83 EUR-26.30%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • KARO BIO (S)24.60 SEK-16.04%

TOP

  • VERONA PHARMA (UK)3.40 GBP25.9%
  • IXICO (UK)35.75 GBP21.2%
  • SERODUS (N)2.71 NOK15.8%

FLOP

  • BIONOR PHARMA (N)0.86 NOK-47.2%
  • STENTYS (F)2.83 EUR-44.3%
  • MOLMED (I)0.24 EUR-35.1%

TOP

  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • KARO BIO (S)24.60 SEK3053.8%
  • 4SC (D)2.95 EUR243.0%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.65 SEK-86.0%
  • BIOTEST (D)13.79 EUR-85.3%
  • EVOCUTIS (UK)0.08 GBP-69.2%

No liability assumed, Date: 13.02.2016