News
Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.
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Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation.”
Lundbeck had tried to scoop the narcolepsy drug maker out from under Alkeremes with $2.4 billion, but Avadel has elected to go with its original suitor.
Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high between FDA Commissioner Marty Makary and Health Secretary RFK Jr.
Communication must be viewed as more than the last step of the research process. It is the structure that makes scientific work clear, trusted and remembered.
What should you do when belief in the mission remains, but the career path doesn’t?
Novo Nordisk goes “on the offensive” following Trump deal that also included rival Eli Lilly, putting an exclamation point on rapidly declining GLP-1 drug prices. Experts say the unusual situation makes it hard to predict what’s next.
Drug candidates don’t usually move among Big Pharma, but these five biotechs helped facilitate such hand-offs, scooping up assets from one pharma on the cheap before being bought out for billions by another.
The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles this summer.
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary hypertension, an indication that, according to BMO Capital Markets, has few treatment options.