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Green light for stem cell study
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Clinical TrialsUK

Green light for stem cell study

15.08.2012 - The British stem cell specialist ReNeuron has received the go-ahead for its phase I trial with disabled stroke patients.

After having reviewed the safety data from the first two dose cohorts, the Data Safety Monitoring Board (DSMB) has recommended to continue the PISCES trial with ReN001. ReNeuron’s ReN001 cell therapy for stroke consists of a neural stem cell line. Until now, no adverse side effects have been found in the review period. Six patients have been included in the trial, the first 18 months ago. “We are delighted that the DSMB have given a favourable recommendation to proceed to the higher and penultimate dose in the PISCES stroke trial,” said ReNeuron’s chief executive Michael Hunt. The study is testing the safety and tolerability of the treatment of ascending doses of the ReN001 cells in patients with moderate to severe functional neurological impairments from their strokes in what is the world’s first fully regulated clinical trial. In June this year, the firm revealed that the first five PISCES patients showed reductions in neurological impairment and spasticity. These improvements were sustained in the longer-term. If everything goes on as planned, ReNeuron could apply for a phase II study in 2013.

http://www.european-biotechnology-news.com/news/news/2012-03/green-light-for-stem-cell-study.html

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

ApprovalEU

04.08.2016 After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to “explore the concept further” and will continue to accept proposals.

BusinessPolandUK

01.08.2016 Life science venture capital group Epidarex has launched Nodthera Ltd, a biotech based on research by Poland-based drug discovery company Selvita. The start-up aims to develop novel inhibitors of the NLRP3 inflammasome.

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No liability assumed, Date: 24.08.2016