The push for legislation that would lower prescription drug prices in the U.S. has mounted in recent months, but support for Medicare pricing negotiations has faltered in the past few weeks. Sen. Bob Menendez (D-N.J.) is the latest Senate Democrat to signal his aversion to giving the government the authority to negotiate prices with drugmakers, breathing new life into hopes that the pharmaceutical industry will yet again escape a mechanism that critics say would suppress innovation at the expense of patients in desperate need of state-of-the-art therapies.
Biotech stocks and the overall market have taken divergent paths in the past month, not unlike what was seen throughout 2020, except this time, they are moving in opposite directions. While BioWorld’s Drug Developers Index (BDDI) appeared to be on the upswing only a month ago, it changed course in the final weeks of September.
Nearly two years after confronting an initial complete response letter, Enzyvant Therapeutics Inc. has won FDA approval for a unique treatment for children born without a thymus, an ultra-rare condition leaving them deeply disadvantaged in fighting infections. The product, to be marketed as Rethymic, is the first thymus tissue product approved in the U.S.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses.
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
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