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An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Johnson & Johnson’s iconic talcum powder product has been the subject of lawsuits and a scathing report that indicated the company allegedly knew that carcinogenic asbestos was sometimes found in the product. As a result, the company has received subpoenas from the federal government.
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz, a JAK inhibitor, has been a strong performer for the company, bringing in $1.77 billion in revenue last year. But now the company has indicated it intends to make a change in its post-marketing study due to safety concerns.
Undergraduate students from around the country will get real-world research experience this summer while participating in Research Experience for Undergraduates programs and other research opportunities on the campus of South Dakota School of Mines & Technology.
Lots of interesting biotech news from Asia, Europe and elsewhere was reported this week. From tapeworms to using a breathalyzer test in lung cancer diagnostics, the global biotech industry is exploding with ideas.
In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age.
The patients were part of a trial assessing Xencor’s mAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia.
The study found that the majority of patients who were given the powerful painkiller did not have cancer or pain associated with the disease, which is what the drug is indicated to help.
On Tuesday, Novo Nordisk said the FDA approved its Biologics License Application for Esperoct (turoctocog alfa pegol) formerly known as N8-GP, for the treatment of children and adults with hemophilia A.
Merck’s Keytruda paired with Pfizer’s Inlyta fares better than standard-of-care treatment in patients of advanced renal cell carcinoma.
The new designation could speed up the time for approval and could also provide a period of market exclusivity for generics of branded medicines that have no competition.