Analysts say Roche’s bispecific antibody Hemlibra will rock the US$15bn haemophilia A market, given that it may circumvent therapy resistance that affects the 30% of patients who form antibodies against recombinant factor VIII products. European Biotechnology spoke with Dr. Gallia Levy, Associate Group Medical Director at Roche, who led clinical development of Hemlibra.
CRISPR & Co are GMOs, says EU court
Latest NewsThe EU Court of Justice has ruled that plants created using novel genome editing methods will be classed as genetically modified organisms and therefore have to follow the strict EU guidelines for GMOs.
Nabriva nabs market-ready antibiotic
Latest NewsIrish Nabriva Therapeutics plc has acquired San Diego-based antibiotics developer Zavante Therapeutics for 8.2 million shares plus US$97.5m in milestone payments.
TxCell snapped up by Sangamo
Latest NewsUS gene editing expert Sangamo Therapeutics is set to acquire French biotech TxCell in an all-cash buyout of €72m on a debt- and cash-free basis.
Determined to reduce the risk of bleeds
BackgroundAnalysts say Roche’s bispecific antibody Hemlibra will rock the US$15bn haemophilia A market, given that it may circumvent therapy resistance that affects the 30% of patients who form antibodies against recombinant factor VIII products. European Biotechnology spoke with Dr. Gallia Levy, Associate Group Medical Director at Roche, who led clinical development of Hemlibra.
Sobi in €387m orphan drug deal with Novimmune
Latest NewsSwedish Orphan Biovitrum AB (Sobi) has signed a €387 deal with Swiss drug developer Novimmune for a late stage antibody targeting a rare haematology disorder.
Novartis pays €945m for eczema programme
Latest NewsEuropean biotechs Morphosys and Galapagos have handed over their joint atopical dermatitis programme MOR106 to Novartis for up to €945m. The Swiss pharma giant aims to strengthen its commitment to lead immuno-dermatology, the company said.
IMI to spur on antibiotics research amidst big pharma pullback
Latest NewsThe Innovative Medicines Initiative has launched a new Antimicrobial Resistance Accelerator Programme after Novartis announced its retreat from antibiotics research only days ago.
Roche granted breakthrough status for liver cancer combo
Latest NewsRoche announced today that the US-American Food and Drug Administration FDA has granted Breakthrough Therapy designation for the Swiss pharma giant’s mAb combination therapy for liver cancer.
Epigenetic biomarkers predict immunotherapy success
Latest NewsUK biotech Oxford BioDynamics has presented data showing that the company’s blood test can predict patient response to treatment with immune checkpoint inhibitors anti-PD-1 and anti-PD-L1.
User-driven early certainty: EPO steps back
BackgroundIt was too good to be true. Following harsh criticism from industry, the European Patent Office (EPO) drafted a widely applauded proposal to allow exemptions to its Early Certainty Initiative in Examination. One month later, the EPO withdrew UDEC following a recommendation from Business Europe – the only business association sitting next to decision-makers in the EPO’s Administrative Council – not to bring UDEC into force in July.