RNAi pioneer is getting closer to market with NDA filing in amyloidosis expected in 2017, but ample competition is coming along, albeit far behind.
The leader in a field others have abandoned, Alnylam Pharmaceuticals Inc., has been working hard to make the case that its RNA-interference technology is moving beyond buzz-worthy platform status into a near-proven modality that is producing late-stage clinical candidates, with its first NDA filing expected in 2017.
With seven candidates in clinical development, expected to reach nine by year's end, the Cambridge, Mass
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.
US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.
