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

AntibodiesDenmarkNetherlands

22.05.2015 Dutch arGEN-X and Danish LEO Pharma are pairing up to develop antibody-based treatments for the chronic inflammation that causes many skin conditions.

M&ANetherlandsGermanyEU

12.05.2015 US pharma is coming to European biotech to fill their pipeline. Pfizer is paying €77.5m for an option on Dutch AM-Pharma, while Juno Therapeutics acquired German biotech Stage Cell Therapeutics for around €72m.

Rare diseasesItalyGermanyPoland

15.05.2015 Rome-based pharmaceutical group Sigma-Tau has sold its blood cancer drug programme Oncaspar to US company Baxter, who aims to spin out its biopharma business.



BiologicsFinlandNetherlandsEU

26.05.2015 The Finnish Medicines Agency Fimea has joined the Dutch MEB in its stance on the interchangeability of biosimilars. The Fimea now sees physician-driven switching of biologics as unproblematic.

SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&AUKSweden

18.05.2015 Double deal for allergy: UK’s speciality biopharma Circassia is boosting its asthma pipeline with the acquisition of Swedish asthma specialist Aerocrine as well as fellow British Prosonix.

BusinessSwedenFrance

02.06.2015 After disappointing Phase III results for immunotherapy tasquinimod and the subsequent discontinuation of the prostrate cancer drug, Swedish Active Biotech is now severely downsizing its operations.

FinancingUK

20.05.2015 The Scottish Government has announced it will double the amount of funds for rare diseases. The New Medicines Fund that was created last year for this purpose will be increased to £80m (€112m).

EPOSwitzerland

30.05.2015 Pharma giant Roche has out-licensed its anaemia drug Mircera to fellow Swiss healthcare company Galenica.

Events

All Events

Partner-Events

Frankfurt am Main (DE)

ACHEMA 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • NEUROVIVE PHARMACEUTICAL AB (S)26.20 SEK19.09%
  • PROTHENA PLC (IE)42.69 USD6.86%
  • GW PHARMACEUTICALS (UK)657.00 GBP5.65%

FLOP

  • ANTISOMA (UK)1.00 GBP-35.48%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • ACTIVE BIOTECH (S)9.45 SEK-10.85%

TOP

  • CHRONTECH PHARMA (S)0.02 SEK100.0%
  • GALAPAGOS (B)51.79 EUR37.8%
  • FLAMEL TECHNOLOGIES (F)19.55 USD36.3%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)26.20 SEK-48.4%
  • CYTOS (CH)0.59 CHF-41.6%
  • ANTISOMA (UK)1.00 GBP-35.5%

TOP

  • CELLECTIS (F)38.88 EUR518.1%
  • WILEX (D)4.11 EUR470.8%
  • ADOCIA (F)67.61 EUR440.4%

FLOP

  • CHRONTECH PHARMA (S)0.02 SEK-81.8%
  • ACTIVE BIOTECH (S)9.45 SEK-72.0%
  • THROMBOGENICS (B)5.33 EUR-70.0%

No liability assumed, Date: 02.06.2015