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This author has not written his bio yet.
But we are proud to say that Uta Mommert contributed 287 entries already.
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.
Extrapolating the current growth in Germany, specialist search engine Viomedo could reach 100,000 monthly users in the beginning of 2017. Being fully operational for only half a year, this would be a sign for nothing less than – as Viomedo’s pharma partners would call it – a huge unmet need.
The European Medicines Agency’s new, accelerated route to approval for innovative drugs seems to be especially attractive for biotech companies. But Health Technology Assessment institutions warn that the lack of substantial data might interfere with reimbursement.
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).
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).
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.
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.
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.
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.