News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Nkarta announced that two of its therapies have shown complete remission in patients with blood cancer. These results are the latest development in the treatment of difficult-to-treat blood cancers.
Swiss pharma giant Roche predicts a revenue slowdown related to its COVID-19 products and the increasing challenge of biosimilar drugs.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Rita Levi-Montalcini is perhaps best known for her award-winning work in the discovery and isolation of Nerve Growth Factor (NGF) in 1956. Here’s more about her.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.
It was yet another busy week for clinical trial news, with a range of studies for COVID-19, various cancers, fungal infections and other indications.
Louisiana Attorney General Jeff Garland sued UnitedHealth Group over Medicaid fraud. In a lawsuit filed earlier this week, Garland alleged the insurance company overinflated drug charges.
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
As Omicron dominates the COVID-19 landscape, scientists are urging the FDA to reconsider how the agency defines immune responses.