News

First FDA approval without trials
Enlarge image

Clinical TrialsUK

First FDA approval without trials

18.12.2012 - GSK’s monoclonal antibody against anthrax is the first to get FDA approval without having been tested for efficacy in humans.

This antibody is a very special one: fast track designation, priority review, orphan drug designation – and the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule: On 14 December, the U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK) raxibacumab injections as a treatment against inhalational anthrax. „In addition to antibiotics, raxibacumab will be a useful treatment to have available should an anthrax bioterrorism event occur,“ said the FDA official Edward Cox. The decision comes as no surprise, as GSK announced that the FDA’s Anti-Infective Drugs Advisory Committee voted 16 to 1 in support of the clinical benefit of raxibacumab – with one abstention on 2 November. The antibody was discovered in a joint venture between Cambridge Antibody Technology and Human Genome Sciences with Cambridge Antibody Technology discovering the antibody to Human Genome Sciences' target. In July 2012 HGS was purchased by GSK.

Inhalational anthrax is a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab neutralizes toxins produced by the bacterium that can cause massive and irreversible tissue injury and death. Raxibacumab has additionally been approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Its efficacy has been shown so far in rabbits and monkeys. „Sixty-four percent of animals in the monkey study and 44 percent of animals in one rabbit study receiving the 40 milligrams per kilogram dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups,“ said GSK in a press release. Trials in humans are not possible due the nature of the disease: Inhalational anthrax is as rare as it is lethal. However, at least the safety of raxibacumab could be demonstrated in 326 healthy human volunteers.

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2012-04/first-approval-without-trials.html

BusinessBelgiumSpain

31.07.2015 Spanish business developer Genetrix has sold its clinical stage cell therapy development subsidiary Coretherapix to Belgian TiGenix in a deal worth up to €267m.

BusinessUKSwitzerland

29.07.2015 Newly founded Mereo BioPharma has acquired three mid-stage clinical assets from Novartis. In turn, the Swiss pharma concern will hold a stake in the UK company. Other investors are also on board.

M&AIreland

28.07.2015 Irish Allergan is bolstering its product pipeline with a takeover of CNS specialist Naurex. At the same time, the company is divesting its global generics business to Teva.

Public marketGermanyFranceBelgiumFinlandDenmarkUK

24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.

FinanceFrance

23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.

BioplasticsFrance

21.07.2015 French biotech Deinove has launched a R&D programme to produce the versatile chemical intermediate muconic acid by using a designer variant of the Deinococcus bacteria.

BusinessFrance

16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.

R&DUK

15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.

FundingUK

13.07.2015 UK drug developer ReNeuron has pulled in £68.4m (€96m) for its cell therapy pipeline for stroke and blindness treatments. Biotech guru Neil Woodford increases his fund’s stake in ReNeuron.

BusinessSweden

10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SERODUS (N)2.60 NOK4.00%
  • SUMMIT (UK)4.03 GBP3.87%
  • FLAMEL TECHNOLOGIES (F)23.88 USD3.83%

FLOP

  • BASILEA (CH)103.50 CHF-13.10%
  • ZELTIA (E)3.69 EUR-8.44%
  • DIAMYD MEDICAL -B- (S)9.20 SEK-6.60%

TOP

  • IXICO (UK)34.00 GBP51.1%
  • DBV TECHNOLOGIES (F)78.26 EUR50.9%
  • ZEALAND PHARMA (DK)149.00 DKK34.8%

FLOP

  • BIOTEST (D)25.40 EUR-63.7%
  • CHRONTECH PHARMA (S)0.01 SEK-50.0%
  • BIOTECH PHARMACON (N)9.74 NOK-43.4%

TOP

  • ADOCIA (F)88.47 EUR565.7%
  • FORMYCON (D)28.89 EUR326.7%
  • DBV TECHNOLOGIES (F)78.26 EUR301.5%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-88.9%
  • NEUROVIVE PHARMACEUTICAL AB (S)22.00 SEK-70.3%
  • NEOVACS (F)1.02 EUR-69.1%

No liability assumed, Date: 30.07.2015