24.10.2012 - The competition for PAH treatments will become fierce. Actelion and Bayer both plan to market new treatments for this rare disease.
Good news for PAH (pulmonal arterial hypertension) patients: two new drugs are planned for market release. The Swiss biotech Actelion submitted a new drug application to the FDA for its Opsumit macitentan treatment. The filing is based on data from a Phase III study, which proved to be able to reduce the risk of a morbidity or mortality event compared to placebo. A low-dose of Opsumit reduced the risk by 30%, while the high dose had a 45% reduction. The compound is a tissue-targeting endothelin receptor antagonist and is thought to replace revenues from Tracleer, Actelion’s best-seller which will lose patent protection in 2015.
At the same time as Actelion announced the application, German pharma Bayer AG announced that its compound riociguat met the primary endpoint in a Phase III study. The oral soluble guanylyl cyclase (sGC) stimulator led to an improvement in a six minute walk test enhancing the patient’s walk distance to 36 meters. Bayer plans to submit regulatory filing for riociguat in the first half next year. Analysts said that macitentan might become the next first-line treatment and expected high revenues. Riociguat however might become a second line option and get additional competition from Pfizer’s Sildenafil, which is already approved for PAH and acts via the same pathway.
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.
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.
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.
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).
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).
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.
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.
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.
FILTRODISC™ BIO SD is a filtration system which removes particles (e.g. cells, bacteria, yeast), impurities (e.g. HCP, DNA) and other turbid matter from process liquids (e.g. fermentation broths). more