Latest from Kevin Grogan
A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.
Daily notebook from the J.P. Morgan Healthcare Conference: Gilead's getting more selective; new Roche BD head explains strategy; Bayer's optimistic about elinzanetant launch; AbbVie looks to expand in oncology; and Edgewise, Scholar Rock and Ionis talk 2025 plans.
On the back of a stellar showing in Phase III, apitegromab is going to be filed in the US and Europe in the coming weeks for spinal muscular atrophy and CEO Jay Backstrom believes it will be a $2bn blockbuster.
Daily notebook from the J.P. Morgan Healthcare conference: Novartis says Kisqali will be its biggest drug yet; BMS reports strong launch for Cobenfy; Sarepta talks plans for building on Elevidys's success; Lilly updates guidance as tirzepatide slips; and GSK's Miels worked overtime on IDRx.