long-awaited results from the IMPROVE-IT cardiovascular outcomes trial have
been hailed as opening the gates for next-generation cholesterol drugs to gain
approval on the basis of LDL reductions alone. That may be true. But the
results also set a bar for CV outcomes that newcomers will have to beat to keep
payers from limiting access to patients who don't do well on inexpensive
advanced players, which have PCSK9 inhibitors in registration, already have
outcomes studies under way, but there is likely to be an 18-month gap between
approval and availability of the study results.
Merck's IMPROVE-IT shows nonstatin LDL-lowering improves CV outcomes, but also sets outcomes hurdles for PCSK9 agents poised in the wings.
Pfizer and Merck KGaA hope their deal will make them front-runners in cancer immunotherapy combos, but they'll have to catch Merck & Co.
GenVec and Novartis worked closely with FDA to move the first gene therapy for hearing loss into the clinic.
Plexcera is developing recombinant ceramidase for Farber disease and a subset of spinal muscular atrophy.
MedDay is repurposing a drug that targets a rate-limiting enzyme in myelination and could stop disease progression in advanced MS.
Why Atlas and NIBR see room for another CRISPR-Cas9 play. Plus: Glionova's head start in GBM; exploiting innovation in Cambridge.
Chiesi Farmaceutici S.p.A (Parma, Italy) has filed a pricing dossier for Glybera alipogene tiparvovec with Germany's Federal Joint Committee (G-BA) that pegs the price of the gene therapy at over EUR 1 million. Chiesi has commercial...
OncoTherapy Science has a potent TOPK inhibitor in a liposomal formulation that avoids the toxicity of other cytokinesis-targeted compounds.
Karolinska's new deputy vice chancellor, Alexander von Gabain, has plans to break down silos and breed new mindsets to maximize the institute’s translational potential.
A paper-based diagnostic using RNA switches could provide an easily distributed, rapid test for infectious diseases in point-of-care settings.
HemoShear's in vitro tumor model shows a new application for its tissue modeling technology and could open it to business from oncology companies.
Overcoming oncogenic KRAS-driven chemotherapy resistance by blocking NRF2 signaling; trifunctional arylpiperazine analogs as antipsychotic agents; inhibiting TRPM2 or RAC1 to treat ischemic kidney injury; and more...
Lysyl oxidase to enhance tensile properties of musculoskeletal grafts; a sorbitol-based PET imaging agent to help diagnose and monitor Enterobacteriaceae infections; genetic variants near estrogen receptor-alpha to predict the risk of breast cancer in Latina women; and more...