News

Enlarge image

RegulatoryFranceGermanyEU

Promising year for TB patients

07.01.2013 - The new year could be particularly beneficial for tuberculosis patients. Two new drugs are expected to be approved by the EMA.

After almost 50 years without new treatments against tuberculosis, 2013 might give patients better options. Both Otsuka Pharma from Japan, as well as Johnson & Johnson's German affiliate Janssen-Cilag GmbH, have ongoing approval procedures for the drugs Delamanid and Bedaquilin, respectively. Bedaquilin was approved by the US regulatory authority FDA at the beginning of the new year. The expected European approvals of both medicines by the European Medicines Agency (EMA) are based on Phase II clinical data with Phase III trials continuing in parallel.  

Also in Phase II, are another two drugs against TB developed by Bayer from Germany and Sanofi from France. However, both substances – Moxifloxacin (yet approved for other indications) and Rifapentin (also already approved by the FDA) – have not entered European approval procedures yet.  

Tuberculosis is mainly spread in Eastern Europe and developing countries but it is also considered an recurring threat for Western Europe. The German Association for Research-Based Pharmaceutical Companies, VFA, estimates that about one third of the earth's population carries the pathogen. Disease outbreaks normally only occur in vulnerable patients following infections by, for example, HIV. Although in general curable, TB has its caveats when compared with other infections of the respiratory tract. Killing mycobacteria without any resistances takes about half a year and comes with nasty side effects. Additionally, many strains have acquired multiple resistances which makes new and better treatment options desirable. That's why the Innovative Medicines Initiative has launched a R&D programme aimed to find better treatments last summer. According to the VFA, some of the upcoming drugs have new modes of actions which makes them especially valuable when mixing different substances for combination therapies. Bedaquilin is the first substance to interfere with energy production of the mycobacteria, while Moxifloxacin is the first to inhibit DNA replication. 

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2013-01/promising-year-for-tb-patients.html

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.

M&AFinland

19.01.2016 Biotie Therapies has long been expanding its business in the US. Now, the Finnish company is set to be taken over by US company Acorda Therapeutics, which is paying €321m for the shares.

Drug AssessmentPortugalFrance

18.01.2016 A Phase I clinical trial for a drug developed by Portuguese pharma company Bial has ended in disaster. One man died, five others may have irreversible neurological damage.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • EVOCUTIS (UK)0.08 GBP14.29%
  • SERODUS (N)2.60 NOK4.00%
  • SUMMIT (UK)4.03 GBP3.87%

FLOP

  • SWEDISH ORPHAN BIOVITRUM (S)12.45 USD-23.38%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • DIAMYD MEDICAL -B- (S)4.30 SEK-12.24%

TOP

  • VERONA PHARMA (UK)3.35 GBP26.4%
  • IXICO (UK)34.00 GBP15.3%
  • WILEX (D)1.95 EUR14.7%

FLOP

  • BIONOR PHARMA (N)0.86 NOK-44.9%
  • PROTHENA PLC (IE)31.71 USD-41.1%
  • PLETHORA (UK)2.62 GBP-36.4%

TOP

  • KARO BIO (S)26.00 SEK3614.3%
  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • NICOX (F)7.00 EUR253.5%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.70 SEK-85.7%
  • BIOTEST (D)13.24 EUR-85.6%
  • EVOCUTIS (UK)0.08 GBP-71.4%

No liability assumed, Date: 08.02.2016