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Cancer center leaders lay bare CAR-T makers' struggles—and an unexpected laggardThis year, the FDA moved two CAR-T therapies into earlier large B-cell lymphoma (LBCL) and cleared a second cell therapy for multiple myeloma. But despite five years of collective experience making a2023/1/3
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Tamiflu generics in short supply in latest chapter of biopharma's shortage sagaDrug shortages have become par for the course in the waning months of 2022, first plaguing the popular ADHD medicine Adderall, then the common antibiotic amoxicillin. Now, generics of Roche’s influen2023/1/3
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After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable SunlencaFour decades after the start of the HIV epidemic, patients whose virus has become resistant to multiple therapies have a new treatment option. Gilead Sciences' Sunlenca is nowclearedto be2022/12/30
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Pfizer, Sanofi settle first California Zantac case slated for trial: reportIn yet another turn in the high-profile Zantac litigation, Sanofi and Pfizer agreed to settle a case set for trial in California. Bloombergfirstreportedthe news of the settlement, which c2022/12/30
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2023 forecast: An 'inflection point' for biopharma, fueled by a flood of AI and machine learning productsWith a platform that can predict which drug candidates will work in humans—and eliminate the costly and inefficient practice of testing on animals—Quris hopes to revolutionize drug development.2022/12/27
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AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delayLess than a week after the FDA reserved judgment on Merck and AstraZeneca’s Lynparza as a treatment for metastatic castration-resistant prostate cancer (mCRPC), Europe hassignedoff on its use in the2022/12/23
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In new lawsuit, J&J's talc subsidiary takes issue with expert witness testimonyAs the seasons change and one year turns to the next, Johnson & Johnson’s talcum powder litigation rolls on. In the latest twist, J&J is taking issue with testimony from an expert witness2022/12/21
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Xeris gets green light to take subcutaneous challenger to AbbVie drug into phase 2Xeris Biopharma has the green light to take its subcutaneous levothyroxine into phase 2. After talking to the FDA, the companyoutlinedplans to start a midphase trial of the investigational alternativ2022/12/21
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AstraZeneca, Merck hit with 3-month delay for Lynparza's FDA filing in first-line prostate cancerIt’s been relatively smooth sailing for AstraZeneca and Merck’s Lynparza as it has gained indications in ovarian, breast, pancreatic and prostate cancer. But on Thursday, the companies reported a2022/12/19
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Activist shareholders ask 9 big pharmas to consider whether 'excessive' patenting hurts accessIt's no secret that drugmakers will do whatever it takes to defend their products from generics for as long as possible. Now, nine drugmakers are being asked to reconsider their patenting strategies.2022/12/19