Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, submitted an application with Japanese regulators for Trerief (zonisamide) for the treatment of parkinsonism in dementia with Lewy bodies.
Immunogen Inc. has enough cash – almost – to reach the phase III readout with antibody-drug conjugate (ADC) mirvetuximab soravtansine (mirv) in ovarian cancer, thanks to the option deal for earlier-stage ADCs with Jazz Pharmaceuticals plc, which paid $75 million up front.
DUBLIN – Astrazeneca could garner as much as $400 million from a deal with Takeda Pharmaceutical Co. Ltd. to co-develop its preclinical alpha-synuclein-targeting antibody, MEDI-1341, which is slated to enter clinical development in Parkinson's disease before year-end.
LONDON – In the thick of Brexit uncertainty over the future of medicines regulation, the ability to recruit staff from Europe and involvement in EU research programs, a U.K. life sciences strategy published Wednesday sets out future plans for the sector.
Biogen Inc., of Cambridge, Mass., reported results from a recently conducted analysis of the long-term extension (LTE) of its ongoing phase Ib study of aducanumab, its treatment for early Alzheimer's disease, including data from the placebo-controlled period and LTE for patients treated with aducanumab up to 24 months in the titration cohort and up to 36 months in the fixed-dose cohorts.
Immix Biopharma Inc., of Los Angeles, said it closed its series A financing to support its lead investigational product, Imx-110, through the completion of a phase Ib trial.
The FDA released a draft revised guidance to provide product-specific recommendations on the design of bioequivalence studies to support ANDAs for digoxin tablets.
HONG KONG – In the wake of the Indian patent office granting U.S. pharmaceutical giant Pfizer Inc. a patent for its pneumococcal conjugate vaccine (PCV), hopes have been dashed for better access to an affordable vaccine against pneumonia in the developing country of more than 1.3 billion people.
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