Drug Development
Treatment with the TROP2 ADC sac-TMT led to a 70% objective response rate and progression-free survival was “significantly improved” as compared to placebo—the second positive readout for the asset this week.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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Analysts say Novo Holdings made the right decision last week in scooping up the CDMO to increase manufacturing capacity for Novo Nordisk’s diabetes and weight-loss drugs.
AVP-786 was unable to significantly reduce total scores in the Cohen-Mansfield Agitation Inventory versus placebo, Otsuka Pharmaceuticals reported Monday. The company is evaluating the next steps for the drug combination.
On Friday, the regulator greenlit Iovance’s lifileucel to treat advanced melanoma. Prior to the approval, experts told BioSpace that tumor-infiltrating lymphocytes therapies also hold the potential to treat several other solid tumors.
CSL’s investigational cholesterol efflux enhancer CSL112 failed to reduce major adverse cardiovascular events within 90 days in patients who had just suffered a heart attack.
Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.
Two Florida courts have sided with Novo Nordisk against Ekzotika and Effinger Health, agreeing that their compounded versions of semaglutide are against the law. The Danish pharma has reached confidential settlements with both companies.
Madrigal Pharmaceuticals announced late-stage results published Thursday in The New England Journal of Medicine for resmetirom as it awaits a March 14 PDUFA date.
Biopharma’s latest earnings season was, in a word, predictable. Companies are consistently beating Wall Street earnings and revenue estimates as they set low expectations for investors.
Following promising Phase IIb studies, Takeda will advance its oral ORX2 agonist TAK-861 into Phase III studies for narcolepsy type 1, while nixing the candidate’s development in narcolepsy type 2.
Investors drove up the price of Kyverna Therapeutics’ stock by 59% in its initial public offering on Thursday afternoon, the first day of trading, reaching a peak per-share price of $35.01.