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Innovent Biologics begins patient dosing in phase I study of IBI3002 in Australia

Thoughts on this? >> FDA blocks approval of Regeneron's blood cancer drug over confirmatory trial enrollment >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #competitivemarketing #pharma #biotech #healthcare

Thoughts on this? >> FDA blocks approval of Regeneron's blood cancer drug over confirmatory trial enrollment >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #competitivemarketing #pharmaceutical #healthcare #pharma

Today we announced positive topline results from our Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab #biosimilar, CT-P43. RT-111 was well-tolerated and delivered ustekinumab with high bioavailability – representing clinical validation of our ability to successfully transform an injectable large molecule into an oral pill. RT-111 has the potential to offer a highly differentiated dosing regimen in psoriasis compared to injectable biologics, oral small molecules, and peptides. These data mark another significant milestone in our progress towards making oral biologics a reality for the millions of patients living with autoimmune conditions. Learn more: https://bit.ly/3SPckoE #OralDelivery #OralBiologics #RaniPill #RaniTherapeutics #psoriasis

Lesson learned REGENERON PROVIDES UPDATE ON BIOLOGICS LICENSE APPLICATION FOR ODRONEXTAMAB TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. #lymphoma #fda #trialdesign #clinicalstudy #regulatoryaffairs #completeresponseletter

Doer Bio completes enrollment in phase 1b/2a trial of DR10624 in obese subjects with modest hypertriglyceridemia

Regeneron Pharmaceuticals recently received a complete response letter (CRL) from the FDA regarding the biologics license application (BLA) for linvoseltamab, a promising treatment for relapsed or refractory (R/R) multiple myeloma. The CRL was issued not due to concerns over the drug's safety or efficacy but rather because of issues identified during a pre-approval inspection at a third-party fill/finish manufacturer unrelated to linvoseltamab. Despite this setback, Regeneron remains committed to bringing this innovative therapy to patients as quickly as possible. Linvoseltamab has shown encouraging results in clinical trials, with a 71% objective response rate and a favorable safety profile. The company is working closely with the FDA and the third-party manufacturer to address the issues and is optimistic about the path forward. This decision highlights the complexities and challenges of the drug approval process, where external factors can delay the availability of potentially life-saving treatments. Regeneron is also continuing to explore linvoseltamab's potential in earlier stages of myeloma, including smoldering myeloma and MGUS, which could further expand its impact in the oncology field. Read more here: https://lnkd.in/ehhAqXDC #MultipleMyeloma #FDA #Regeneron #Oncology #Biopharma #DrugDevelopment

So proud of the work the Corbus Pharmaceuticals team put into making this happen. Next step: explore this MOA in the clinic and examine the effects of modulating latent TGFbeta activation in the TME. https://lnkd.in/e2yKZ6PZ

Polpharma Biologics, a biotech company specializing in biosimilars, announced positive topline results for their biosimilar candidate PB016, compared to the reference drug Entyvio® (vedolizumab). The study involved 120 healthy subjects and showed PB016's comparability in pharmacokinetics (PK) and pharmacodynamics (PD), with no safety concerns or immunogenicity issues. 𝐓𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐲 𝐬𝐞𝐞𝐬 𝐏𝐁𝟎𝟏𝟔 𝐚𝐬 𝐚 𝐩𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 𝐜𝐨𝐬𝐭-𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐚𝐥𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐯𝐞 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐦𝐢𝐥𝐥𝐢𝐨𝐧𝐬 𝐬𝐮𝐟𝐟𝐞𝐫𝐢𝐧𝐠 𝐟𝐫𝐨𝐦 𝐢𝐧𝐟𝐥𝐚𝐦𝐦𝐚𝐭𝐨𝐫𝐲 𝐛𝐨𝐰𝐞𝐥 𝐝𝐢𝐬𝐞𝐚𝐬𝐞𝐬 (𝐈𝐁𝐃). 𝐖𝐢𝐭𝐡 𝐏𝐁𝟎𝟏𝟔 𝐞𝐧𝐭𝐞𝐫𝐢𝐧𝐠 𝐥𝐚𝐭𝐞-𝐬𝐭𝐚𝐠𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐏𝐨𝐥𝐩𝐡𝐚𝐫𝐦𝐚 𝐁𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐬 𝐚𝐢𝐦𝐬 𝐭𝐨 𝐬𝐞𝐜𝐮𝐫𝐞 𝐜𝐨𝐦𝐦𝐞𝐫𝐜𝐢𝐚𝐥 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬 𝐟𝐨𝐫 𝐭𝐡𝐢𝐬 𝐚𝐬𝐬𝐞𝐭. Further clinical trials are underway to provide more evidence on PB016's efficacy and safety in patients with ulcerative colitis (UC). 𝐕𝐞𝐝𝐨𝐥𝐢𝐳𝐮𝐦𝐚𝐛, 𝐭𝐡𝐞 𝐭𝐚𝐫𝐠𝐞𝐭 𝐝𝐫𝐮𝐠, 𝐢𝐬 𝐚 𝐦𝐨𝐧𝐨𝐜𝐥𝐨𝐧𝐚𝐥 𝐚𝐧𝐭𝐢𝐛𝐨𝐝𝐲 𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐝 𝐟𝐨𝐫 𝐭𝐫𝐞𝐚𝐭𝐢𝐧𝐠 𝐔𝐂, 𝐂𝐫𝐨𝐡𝐧'𝐬 𝐝𝐢𝐬𝐞𝐚𝐬𝐞, 𝐚𝐧𝐝 𝐩𝐨𝐮𝐜𝐡𝐢𝐭𝐢𝐬 𝐢𝐧 𝐯𝐚𝐫𝐢𝐨𝐮𝐬 𝐜𝐨𝐮𝐧𝐭𝐫𝐢𝐞𝐬. Polpharma Biologics, with a focus on expanding access to biological medicines, is actively developing a pipeline of biosimilars across multiple therapeutic areas. #marketintelligence #competitiveintelligence #marketsmind #biosimilars #pharmaceutical

[ESMO] ABL Bio’s 'B7-H4x4-1BB' target 'ABL103' gains traction with major pharma: Meetings held with three industry giants - [Interview] ABL Bio CEO, Lee Sang Hoon - "Of the four companies involved in the meetings, three are major pharmaceutical firms, with two having initiated discussions since AACR and ASCO" - "Technology transfer for ABL103 is possible either before or at the end of phase 1 clinical dose escalation phase" - "ABL503 has also attracted interest from other companies since ASCO, highlighting the growing need for next-generation 4-1BB targets" https://lnkd.in/ga3qACyn