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Innovent says next-gen GLP-1 drug from Eli Lilly beats top diabetes med in...

A next-generation GLP-1 candidate from Eli Lilly has outdone an older Lilly drug in a Phase 3 trial involving Chinese patients with diabetes, Lilly partner Innovent announced late Wednesday. The...

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Rapt Therapeutics winds down Phase 2 studies of lead candidate in wake of...

Rapt Therapeutics said it will close and unblind two mid-stage trials in atopic dermatitis and asthma after they were put on clinical hold earlier this year due to a case of liver failure. The company...

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Nucleus RadioPharma makes Artbio’s radiopharma assets; Minaris manufactures...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. CDMO Nucleus RadioPharma is partnering with clinical-stage company...

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Charles River touts first-quarter manufacturing revenue, says China bill is...

Charles River Laboratories’ manufacturing arm delivered a large revenue jump in the first quarter of the year owing to an uptick in customer activity. James Foster The company also noted that it...

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Verona inks financing deal worth up to $650M ahead of COPD decision

Verona Pharma has secured up to $650 million to aid the potential launch of its COPD candidate ensifentrine. Under new agreements with Oaktree Capital Management and OMERS Life Sciences, Verona can...

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Bluebird bio starts 15 patients on its three multimillion-dollar gene therapies

Bluebird bio’s stock $BLUE jumped over 20% on Thursday following its first-quarter earnings release and the announcement of 15 patients starting on its three approved gene therapies: Zynteglo, Skysona...

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Across two clinical trials, gene therapy restores hearing in children deaf...

BALTIMORE — Ten out of 11 children who were born deaf can now hear after receiving a gene therapy from a Shanghai biotech, according to new results shared Thursday. The children who recovered their...

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Ahead of likely approval, ICER finds Geron’s imetelstat is not cost-effective...

In the lead-up to the likely approval of Geron’s drug to treat certain types of anemia, drug pricing watchdog the Institute for Clinical and Economic Review said Thursday that the drug would not be...

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Takeda to shut down San Diego research center 

Takeda is shuttering its San Diego research site, the company confirmed to Endpoints News. The company told employees on Thursday that it will close the site as part of a decision “to focus more of our...

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Corrected: Experts to decide within a year whether to recommend Duchenne...

An advisory committee has postponed its decision to decide whether Duchenne muscular dystrophy should be included in a federally-recommended newborn screening panel for up to one year, Parent Project...

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BIO CEO defends the organization's about-face on the Biosecure Act

As the head of the trade group BIO and a parent to children with a rare disease, John Crowley is personally and professionally at the center of a bill targeting Chinese biotechs. Under Crowley, BIO...

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After FTC scrutiny of Sanofi deal, Maze finds a new Pompe partner in Shionogi

Maze Therapeutics has found a new buyer for its Pompe disease candidate, five months after scrutiny from the Federal Trade Commission led Sanofi to back out of a deal for the clinical-stage drug. The...

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AGC Biologics to cut close to 4% of staffers 'to adjust business priorities'

CDMO AGC Biologics is laying off just under 4% of its workforce across its headquarters in Seattle, WA, a site in Boulder, CO, and “some supporting global functional areas,” a company spokesperson told...

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Sanofi makes $1.2B deal with Novavax on Covid vaccine, explores flu combinations

Sanofi is handing Novavax $500 million upfront to bring the biotech’s Covid-19 vaccine into the fold, with dual goals of co-commercializing the current vaccine and developing combo vaccines that can...

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FDA delays Moderna RSV vaccine decision, but what's next is likely to be a...

The FDA has delayed the PDUFA date for Moderna’s RSV vaccine, the company announced Friday morning. The delay likely won’t push the decision past the end of May, according to Moderna’s press release,...

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Lykos shores up commercial team for MDMA drug; Former J&J CEO Alex Gorsky...

Allison Rosenthal Lykos Therapeutics is on a journey to get the first MDMA-assisted PTSD therapy approved by the FDA, and the biotech has tapped two new leaders to complete the trip. The additions of...

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MacroGenics investigates three patient deaths in Phase 2 prostate cancer drug...

MacroGenics reported on Thursday afternoon that three patients died in a mid-stage trial of its antibody-drug conjugate for prostate cancer. Two participants died due to pneumonitis and the third died...

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Tessera unveils promising in vivo gene editing treatment for sickle cell in...

Tessera Therapeutics, a well-funded startup based outside of Boston, announced Friday that it developed a lipid nanoparticle that shuttles a gene editing therapy directly to the bone marrow of mice....

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Ginkgo to cut spending, lay off staff after earnings disappointment

Ginkgo Bioworks is looking to cut expenses and personnel in an effort to return to profitability and break even by the end of 2026. The company said it is planning to reduce operating expenses —...

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iTeos to raise $120M; Xbrane and STADA to out-license Lucentis biosimilar

Plus, news about AnaptysBio, Alzamend, AEON Biopharma and argenx: iTeos Therapeutics’ $120M offering: The immuno-oncology company is selling about 1.1 million shares for $17.50 apiece. RA Capital...

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