Former FDA commissioner Scott Gottlieb, who unexpectedly announced his resignation from the role in March, has attracted controversy by joining Pfizer's board of directors, it was announced this week.
Ex-FDA commissioners have frequently moved into industry positions, though it is the speed at which Gottlieb has joined Pfizer that has prompted scrutiny and calls from Senator Elizabeth Warren for him to step down.
Gottlieb said he is proud of his new role at Pfizer and would be contacting Warren privately to discuss the matter.
Pfizer provides DMD update, Sarepta benefits
Sarepta Therapeutics appears to have strengthened its position of leadership within the increasingly competitive field of Duchenne muscular dystrophy (DMD), thanks to the unveiling of mixed clinical data for an experimental gene therapy being developed by Pfizer.
With Sarepta developing its own gene therapy - among other therapeutic approaches - this could prove particularly important in terms of future patient enrolment.
A leading expert told FirstWord this week that whilst Sarepta's data is the most encouraging published, question marks about DMD gene therapies remain, including their impact in terms of functional benefit.
Other approaches to treating DMD therefore remain important - see ViewPoints: The best of what's left- a who's who of non-gene therapies for DMD.
What next in rheumatoid arthritis?
With AbbVie's JAK inhibitor upadacitinib likely to be approved for rheumatoid arthritis by the FDA next month (see New drug approvals in 2019 - what’s left to come…), Gilead Sciences and partner Galapagos are seeking to keep up the pressure; they expect to file their own JAK inhibitor filgotinib with the FDA by year-end.
Meanwhile, GlaxoSmithKline has confirmed that its GM-CSF targeted antibody otilimab will enter Phase III studies, and will notably be evaluated head-to-head against Pfizer's established JAK inhibitor Xeljanz in two of these trials.
Amarin's bullish upgrade
Amarin is also awaiting an important decision by the FDA; authorisation based on results from the REDUCE-IT cardiovascular outcomes study for its Omega-3 drug Vascepa. A decision on whether to approve labelling to include lowering residual cardiovascular risk in patients with statin-managed LDL cholesterol and persistent elevated triglycerides is expected in late September, with the FDA yet to inform Amarin whether an advisory committee will be convened to discuss its application.
In the meantime, Amarin has once again increased its full-year revenue forecasts for Vascepa to between $380 million and $420 million, and announced plans to double its sales force; factors that will no doubt keep chatter about the company as a potential acquisition target high on the agenda. Physicians are clearly impressed with data from REDUCE-IT and using Vascepa off-label.
Our snap-poll of US-based cardiologists and primary care physicians from earlier this week provides further insight. More here.
Boehringer and Yuhan look to double up in NASH
Not perturbed by a number of recent setbacks in the field, Boehringer Ingelheim has entered a collaboration and license agreement with Yuhan potentially worth up to $870 million to develop a dual agonist combining GLP-1 and FGF21 activity in one molecule for the treatment of non-alcoholic steatohepatitis (NASH) and related liver diseases.
The deal includes upfront and near-term payments of $40 million from Boehringer Ingelheim, with Yuhan also eligible to receive up to $830 million in potential milestone payments plus tiered sales royalties.
The companies noted that the dual agonist is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis, as well as having direct anti-fibrotic effects.
In an interview with FirstWord Michael Mark, head of global cardio-metabolic research at Boehringer discussed how this deal has been in the making for some time.
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