FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence
Under the terms of the agreement, DL Medicine will screen and collaborate with Pfizer in producing new chemical entities against pre-selected targets from multiple therapeutic areas. As part
CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, the Regenerative Medicine Advanced Therapy (RMAT) designation. In notifying Capricor, the FDA Office of Tissues
This acceptance follows submission of the MAA in December 2017. GW CEO Justin Gover said: “The successful filing of the MAA for Epidiolex with the EMA builds on
PharmAbcine’s lead candidate TTAC-0001, an investigational therapy, is a highly selective and potent anti-VEGFR2 (KDR/flk-1) mAb in clinical development for rGBM indications. VEGFR2 is over-expressed in most malignant tumors,
The grant is from Innovate UK's Medicines Manufacturing Round 1: Challenge Fund, which itself is funded through the UK Government's £70m Industrial Strategy Challenge Fund to speed up
It was approved to treat HABP/VABP caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae
Under the terms of the agreement, Syndax and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in multiple solid tumor types.
The company has engaged Rothschild as its independent financial advisor to assist Juniper and its Board of Directors in evaluating potential strategic alternatives. Juniper president and CEO Alicia
SAGE-217, administered as a single dose at either 30 or 45 mg, significantly improved sleep efficiency (SE), the primary endpoint of the trial, to a median of 85
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