28.08.2012 - Swiss Roche AG reports its antibody-drug conjugate trastuzumab emtansine (T-DM1) improves overall breast cancer survival – and files MAAs.
After first promising news in spring Basel-headquartered F. Hoffmann-La Roche AG adds more substantiating Phase III data concerning the benefit of its antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1). On 27 August, the company and its licence partner ImmunoGen announced that the conjugate not only significantly improved progression-free survival (PFS) but also overall survival (OS) in patients with metastatic breast cancer. Patient data – which will be presented at an upcoming medical meeting – stems from the EMILIA Phase III trial. In EMILIA, the new drug was tested on 991 patients with HER2-positive non-resectable locally advanced or metastatic breast cancer who had previously unsuccessfully received trastuzumab (Herceptin) plus chemotherapy. Enrolled patients either fell into the T-DM1-only group or into the control, standard-of-care group receiving lapatinib (Tykerb) plus capecitabine (Xeloda). Roche also announced that it is about to submit the marketing application for T-DM1 to the European Medicines Agency (EMA).
Genentech Inc., a Roche subsidiary situated in San Francisco (USA), is the developer of T-DM1. The company has already filed a marketing application for the drug to the Food and Drug Administration (FDA) in the US. The development was accomplished under an agreement with ImmunoGen, Inc. from Waltham (USA). The company from Massachusetts provides the linker chemistry and the compound drug’s cancer killing agent, which is targeted by the antibody (trastuzumab) to Her2neu tumour cell receptors. ImmunoGen calls its technology TAP, Targeted Antibody Payload. The cytotoxic agent is a derivative of maytansine that inhibits the assembly of microtubules. Maytansines are potent toxins that naturally occur in the shrubs and trees of the Genus Maytenus spp.
26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.
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.
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