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At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
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AbbVie (NYSE: ABBV) today announced that researchers will present new, long-term data supporting the efficacy and safety profile of RINVOQ® (upadacitinib) from the SELECT-COMPARE, SELECT-PsA 1 and SELECT-AXIS 2 studies at the European Congress of Rheumatology, EULAR 2023, taking place from 31 May – 3 June in Milan.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Lilly’s muvalaplin is the first oral drug to show positive Phase II findings for Lp(a) reduction, eliciting up to an 86% drop in the biomarker after 12 weeks.
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly.
Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.
Neurogene’s shares fell by 36% as the market opened Monday morning following news that a patient experienced systemic hyperinflammatory syndrome in a Phase I/II clinical trial of Rett syndrome gene therapy NGN-401.
Wegovy is being made available to Chinese patients five months after its approval in the country. Novo will sell the medicine for about $193.27 for a one-month supply.
Boston Pharma’s once-monthly injection efimosfermin alfa offers a convenient dosing option for MASH patients while also achieving promising rates of fibrosis and MASH improvement, according to a Phase II readout.
Analysts appear optimistic for Intellia’s gene editor nex-z, which showed a greater serum TTR reduction than Alnylam’s Amvuttra.
With the failure of AbbVie’s emraclidine in two mid-stage trials, Bristol Myers Squibb’s Cobenfy is ‘sole muscarinic winner.’
Bluebird has just two quarters until it’s out of cash. Executives are looking for financing to extend that runway to a projected breakeven point before the end of 2025, with analysts worried they won’t make it.