Ten days after its JAK1 inhibitor, itacitinib, failed a phase III trial in acute graft-vs.-host-disease (GVHD), Incyte Corp. has finalized a deal that could provide an alternative growth path. It is paying Morphosys AG $750 million up front, investing $150 million in its stock and is on the hook for up to $1.1 billion in milestones for a 50% interest in U.S. rights to the CD19-targeting antibody tafasitamab (MOR-208) and for 100% of the rights in all other territories. Read More
Eqrx Inc., a new venture created to advance fast-follower drugs that founding CEO Alexis Borisy said will be priced "radically lower" than first-in-class medicines, launched with $200 million in series A financing. Read More
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug. Read More
Pfizer Inc. was a swinging door today as it sold its small molecule for treating patients with behavioral and neurological symptoms to Biogen Inc., while licensing reboxetine’s data and intellectual property and granting esreboxetine’s development and commercialization rights to Axsome Therapeutics Inc. Read More
SAN FRANCISCO – Atop the stage where, just a year ago, he'd detailed the then-new $74 billion acquisition of Celgene Corp, Bristol-Myers Squibb Co. CEO Giovanni Caforio told attendees of this year's J.P. Morgan Healthcare Conference he intends to plunge ahead with "the agility and speed of a biotech company." Read More
While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth. Read More
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD). Read More
SAN FRANCISCO – Pacing the stage at this year's China Showcase Saturday, Chinabio CEO Greg Scott sounded a touch disappointed. Last year lacked the kind of record-breaking stats he likes to punctuate with iconic explosions, a common image in his widely valued China health care talks. "Simply stated, business is continuing as normal," he said. Read More
LONDON – Kandy Therapeutics Ltd. has announced positive results for its nonhormonal treatment for menopause symptoms, showing a reduction in the number of hot flashes and night sweats, and a positive effect on secondary endpoints relating to mood and quality of life. Read More
Gennbio Co. Ltd. has signed an agreement with fellow Korean biotech Genexine Inc. to in-license two immunosuppressant drug candidates called GX-P1 (PD-L1 hyfc) and BSF-110 (PD-L1-hyFc-1L10m). Read More
BEIJING – China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its PD-1 antibody, Tyvyt (sintilimab), and Sirnaomics Inc.’s RNAi drug candidate, STP-705. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More