Moderna’s Covid-19 and flu combo vaccine succeeds in Phase 3 study
Moderna’s Covid-19 and influenza combination vaccine was comparable to shots separately marketed for the two infections in a Phase 3 trial, the company announced Monday morning. Plans are underway to...
View ArticleGSK nixes SpringWorks licensing deal focused on Blenrep-Ogsiveo for blood cancer
GSK is walking away from an expanded partnership deal with SpringWorks Therapeutics, winding down further research activities that would combine Blenrep and Ogsiveo. The UK pharma sent SpringWorks a...
View ArticleAlumis files for IPO ahead of Phase 3 studies for second-generation TYK2...
Precision immunology startup Alumis has filed to go public, pitching itself to Wall Street just three months after raising $259 million from private investors. Alumis didn’t include an estimated figure...
View ArticleShionogi inks deal for preclinical hearing loss therapies; Alvotech’s...
Shionogi licenses hearing loss treatments in deal up to €400M: The Japan-based pharma company paid Cilcare €15 million ($16.1 million) upfront for the option to license two preclinical hearing loss...
View ArticleSkye's stock sinks following eye disease failure as company shifts focus to...
Skye Bioscience is abandoning its entire eye disease pipeline following a Phase 2a trial failure, and it’s pivoting to one of the hottest categories in the industry — obesity. The San Diego-based...
View ArticleOculis touts Phase 2 results in dry eye disease, but most data aren't...
Oculis teased that its dry eye disease therapy worked in a mid-stage trial, but it stopped short of reporting statistically significant data across most endpoints. The ophthalmology biotech identified...
View ArticleEU launches two advice pilots for clinical trial applications as part of R&D...
The EU has initiated two pilot programs aimed at boosting the quality of clinical trial applications amid a broader effort to better integrate clinical research into the European health system. The two...
View ArticleClik here to view.
Teladoc names insurance executive as new CEO
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) After two months of searching, Teladoc Health has hired Chuck Divita to be its new CEO as the telehealth...
View ArticleFDA establishes new meeting type to advise on drug safety technology
The FDA’s drug center is creating a new way for sponsors to talk with the agency about how they’re using artificial intelligence and other technologies to conduct pharmacovigilance, the regulator...
View ArticleKyowa Kirin invests $530M in first manufacturing site in North America
Kyowa Kirin is investing $530 million into a 171,700 square-foot manufacturing facility in Sanford, North Carolina, which will make biologic therapies, including antibodies, for clinical trials and...
View ArticleGSK stands by Orange Book patents that FTC has asked to rescind
British drugmaker GSK says it has no current plans to pull a group of patents that have been challenged by the US Federal Trade Commission as “junk.” In April, the FTC expanded an ongoing campaign...
View ArticlePaxlovid did not beat placebo in Stanford-led long Covid treatment trial
Pfizer’s Covid-19 antiviral did not improve symptoms in patients with long Covid compared to placebo — the latest disappointment for patients with the post-infection condition. Scientists at Stanford...
View ArticleFDA advisors back Lilly’s Alzheimer’s drug, setting stage for approval after...
An FDA advisory committee gave its strong backing to Eli Lilly’s Alzheimer’s drug donanemab, giving further support for the agency’s expected approval after a surprise delay earlier this year. The...
View ArticleClik here to view.
Ipsen and Genfit’s elafibranor secures FDA thumbs up in rare liver disease
Ipsen’s drug candidate for a rare liver disease secured accelerated approval from the FDA on Monday, making good on a licensing deal with Genfit that dates back to 2021. The candidate dubbed...
View ArticleExclusive: Auxilius raises $10M to help biotechs manage clinical trial finances
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) The cost to develop a drug and the complexity of clinical trials has increased over the years. And as...
View ArticleNew obesity biotech Syntis Bio launches with early-stage alternative to GLP-1s
Syntis Bio is joining a growing group of smaller companies that are moving into the obesity treatment space — but not with a GLP-1. Instead, the Boston-based biotech is launching SYNT-101, an oral...
View ArticleOscar stakes its future on companies dumping worker health benefits
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) More than 153 million people get health coverage through their employers. Oscar Health is banking on...
View ArticleClik here to view.
BIO's new CEO takes a patriotic pivot to win back Congress, pushing industry...
SAN DIEGO — Facing an existential moment in how drugs are developed and sold, biotech’s key lobbying group has entrusted a new leader, who is wrapping himself in the US flag to regain a seat at the...
View ArticleClik here to view.
ARCH backs lab instrument company that wants to help demystify how cells talk...
Moleculent emerged from stealth on Tuesday with $26 million to develop next-generation lab equipment that can look at how cells interact with each other in exquisite detail, joining a hot and litigious...
View ArticlePivoting to ‘ADC-like’ approach, Versant-backed startup gets $90M Series C
Bright Peak Therapeutics announced a $90 million Series C, though its scientific focus and pipeline looks different than it did three years ago. Shortly after the company raised a $107 million Series B...
View Article