News
Busy with Casgevy and Journavx launches, Vertex sets ambitious $500M revenue goal for non-CF meds this year
28+ min ago (744+ words) Cystic fibrosis (CF) specialist Vertex is tracking two newer launches that speak to its efforts to expand its prowess beyond those roots. Despite mixed early results for those rollouts so far, the company is forecasting a major acceleration of non-CF…...
Astellas casts retina specialists as ‘Partners in Protection’ in Izervay HCP campaign
34+ min ago (559+ words) A new campaign for Astellas Pharma's Izervay is aimed at opening retina specialists' eyes to the unique role they play in their geographic atrophy (GA) patients' lives. The "Partners in Protection" initiative, spanning print, digital and social media channels, showcases…...
Bayer and celebrity chef keep diners in the dark to shed light on heart health
1+ hour, 36+ min ago (409+ words) Bayer has cooked up the next phase of its "See Your Risks" campaign, tapping Food Network star Jeff Mauro as its sous chef." In honor of February's American Heart Month, the drugmaker is"offering people the chance to dine in…...
Novartis to seek full FDA approval for IgAN drug Vanrafia despite missing ph. 3 kidney function goal
1+ hour, 39+ min ago (391+ words) It's d'j" vu all over again. Just as the kidney disease space becomes increasingly competitive, Novartis has found itself intending to turn a statistical miss into a regulatory win. Despite the phase 3 Align trial narrowly failing to hit its kidney…...
Lilly's pre-launch inventory of oral GLP-1 candidate swells ahead of expected FDA obesity nod
2+ hour, 51+ min ago (436+ words) Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron." Specifically, Lilly had secured "pre-launch inventories" worth $1.5 billion as of…...
With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment
6+ hour, 18+ min ago (495+ words) The regulatory environment in the United States encountered by Moderna during the development of its COVID-19 vaccine bears little resemblance to what the company experienced earlier this week when the FDA refused to review its application for approval of its…...
PTC shuts down FDA approval bid for troubled Duchenne med Translarna
7+ hour, 26+ min ago (484+ words) With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna." Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation…...