Oncology

With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.

The US biotech’s LOXL2 inhibitor candidate has reduced collagen fibrosis of the bone marrow in a small number of Phase II patients, helping validate a historically tricky approach attempted by few.

Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.

After slashing the prices of their blockbuster drugs to gain wider patient access through China's main reimbursement program, multinationals are now beginning to face increasing challenges from local competitors.

New data from anemic myelofibrosis patients showed the drug reduced transfusion dependence, which that could unlock a more sizeable portion of the market for CTI BioPharma.

As the first CRISPR-based therapies draw closer to approval, the Flagship-backed biotech believes its gene writing tech is the ‘definitive’ genetic medicine platform.

The UK firm with a presence in Boston has just emerged but Pheon’s CEO Bertrand Damour tells Scrip that big pharma is already showing interest in its next-generation antibody-drug conjugate.

The start-up will secure $70m from Genentech, after closing a series B financing, while it moves its first CAR-T program into the clinic for ovarian cancer later this year.

The French biotech has presented positive Phase II data on lacutamab in mycosis fungoides at the EORTC-CLTG meeting in Madrid which looks to have de-risked the asset.

Having finally confirmed the Sandoz spin-off, Novartis will become a 'pure play' pharma company and focus on picking bigger blockbuster winners from both internal and external pipelines. CEO Vas Narasimhan talked details at an investor day in Basel.

PARP inhibitors have had great success in treating a number of cancers but the German major has placed a $65m bet that Nerviano's selective PARP1 approach could produce a safer and more efficacious option.

Merging with the shell of troubled cancer biotech Sesen, Carisma believes its chimeric antigen-receptor-macrophage (CAR-M) platform can bring the immunotherapy application to solid tumors.