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as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another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.
FEATURED STORIES
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.
FROM OUR EDITORS
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.
THE LATEST
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
While a JAMA study found a decline in mpox antibody responses after vaccination, a University of Oxford expert cautioned that there is still not enough evidence to determine if this decline also leads to waning protections.
Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections.
The adjusted guidelines will provide drugmakers with more opportunities to engage with the Centers for Medicare and Medicaid Services regarding the initial maximum fair price offers, according to the agency.
The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe.
BMO Capital Markets analyst Evan Seigerman called it “another positive indication” for Eli Lilly, whose top-selling diabetes and weight loss drugs are gaining market share as manufacturing continues to expand, while noting the drugmaker could start to benefit heading into third quarter earnings.
Stephen Majors from the Alliance for Regenerative Medicine, which hosts the conference, spoke with BioSpace about what the more than 2,000 attendees can expect to learn next week in Phoenix about the pressing issues confronting the industry.
ImmunityBio will lay off 15 employees in California, mostly in El Segundo, effective Nov. 25. The company is also letting go 16 employees later this month.
To say that 2seventy bio’s short two years of existence have been dramatic is an understatement. CEO Chip Baird told BioSpace transparency and a committed staff have kept the biotech going through thick and thin.
Big Pharma companies Bayer and Johnson & Johnson are downsizing their New Jersey workforces while Pfizer cuts jobs in Ireland. Many of the layoffs are effective by the end of the year.