The US Food and Drug Administration has granted ‘breakthrough therapy’ status to a gene therapy that is in Phase 3 development for patients with an inherited eye disorder that can lead to blindness. The developer is Spark Therapeutics of Philadelphia, Pennsylvania.
After issuing a complete response letter in late 2013, the Food and Drug Administration has now approved Lemtrada (alemtuzumab) for patients with relapsing multiple sclerosis. This follows a review of efficacy data from two Phase 3 trials.
Fresh from a European initial public share offering that raised €41.8 million, ArGEN-X NV has advanced development of its lead antibody ARGX-110 for CD70-positive cancers, including plans for a US study in an incurable B-cell lymphoma.
Dendreon Corporation, developer of the first ever FDA-approved cellular immunotherapy, announced on 10 November that it had filed for protection from its creditors under Chapter 11 of the US Bankruptcy Code.
Evotec AG has confirmed its guidance for 2014 according to which it expects to deliver a positive operating cash flow and liquidity in excess of €90 million by 31 December. This takes into account planned investments of €5 to €7 million to upgrade infrastructure.
Histide AG, a Swiss biotech company founded in 2014, has raised CHF 4.5 million (€3.74 million) to develop its extracellular technology for directing cell fate. The funds were provided by Parter Capital Group AG and a number of private investors.
Circassia Pharmaceuticals Plc, which has a portfolio of immunotherapy products for allergies, said that it is on track to complete recruitment by year end for a Phase 3 study of its lead product for cat allergy. Results of the trial are expected in the first half of 2016.
MorphoSys AG has made an upward revision to its financial forecast for 2014 reflecting a milestone payment from its antibody development partner Janssen Biotech Inc, and a partial shift of expenses to 2015. Concurrently it has expanded its proprietary platform.
Revenue was sharply higher at Genmab A/S in the third quarter and the first nine months of 2014 owing to the clinical progress of the company’s monoclonal antibody daratumumab which is being investigated for multiple myeloma.
Cardio3 BioSciences SA of Belgium has acquired the US medical device specialist, CorQuest Medical Inc, for an undisclosed amount of money in order to strengthen its heart failure franchise. Cardio3 already has an autologous stem cell treatment for heart failure in Phase 3 development.