Merck’s Keytruda receives new approvals in Japan for NSCLC and urothelial carcinoma
- The Japanese Ministry of Health, Labor and Welfare (MHLW) approved new indications for Keytruda in certain lung and urothelial cancers.
- Keytruda, combined with chemotherapy, is approved as a neoadjuvant and adjuvant treatment for non-small cell lung carcinoma (NSCLC) based on Phase 3 KEYNOTE-671 trial results.
- Keytruda, combined with Padcev, is approved for first-line treatment of radically unresectable urothelial carcinoma based on Phase 3 KEYNOTE-A39 trial results.
- Keytruda monotherapy is approved for patients with radically unresectable urothelial carcinoma who are ineligible for platinum-containing chemotherapy, based on Phase 2 KEYNOTE-052 trial results.
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MesoPher cell therapy increases 2-year RFS rate in resected pancreatic cancer by 50%
- Amphera B.V. announces phase II trial results of MesoPher cell therapy in resected pancreatic cancer.
- The trial showed a 64% 2-year recurrence-free survival rate, compared to an expected 40%.
- 2-year overall survival rate was 83%, with low-grade side effects.
- MesoPher received Orphan Designation from both the FDA and EMA for pancreatic cancer.
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Orion’s collaboration partner Bayer submits application to U.S. FDA for third indication of darolutamide
- Bayer has submitted a supplemental new drug application (sNDA) to the U.S. FDA for darolutamide.
- The application seeks approval for darolutamide in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC).
- The submission is based on positive results from the Phase III ARANOTE trial, showing a 46% reduction in the risk of radiological progression or death.
- Darolutamide is already approved in over 80 markets for mHSPC and in more than 85 countries for non-metastatic castration-resistant prostate cancer (nmCRPC).
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BioAge Labs announces pricing of upsized initial public offering
- BioAge Labs priced its upsized IPO at $18.00 per share, offering 11,000,000 shares.
- Gross proceeds expected to be $198.0 million before deductions.
- Shares to trade on Nasdaq Global Select Market under ticker 'BIOA' starting September 26, 2024.
- Underwriters have a 30-day option to purchase an additional 1,650,000 shares.
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Guardian Pharmacy Services announces pricing of upsized initial public offering
- Guardian Pharmacy Services priced its upsized IPO at $14.00 per share for 8,000,000 shares of Class A common stock.
- Underwriters have a 30-day option to purchase up to 1,200,000 additional shares at the public offering price.
- Shares will trade on the NYSE under the symbol 'GRDN' starting September 26, 2024.
- The offering is expected to close on September 27, 2024, subject to customary closing conditions.
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AB Science provides an update on the microtubule program AB8939 and its response to MECOM rearrangement
- AB8939 is a novel microtubule destabilizer currently in phase 1 clinical trial for refractory and relapsed acute myeloid leukemia (AML).
- The trial has completed the first step of determining the maximum tolerated dose (MTD) for 3 consecutive days of treatment and is now evaluating 14 consecutive days.
- New data show AB8939 generates a complete response in combination with Vidaza in a patient-derived xenograft (PDX) mouse model with MECOM rearrangement.
- AB8939 has shown a 50% response rate in MECOM cell lines ex vivo and in phase 1 trial patients, with no severe bone marrow toxicity observed.
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ANI Pharmaceuticals announces the FDA approval and launch of ketoconazole shampoo, 2%
- ANI Pharmaceuticals received final FDA approval for its Abbreviated New Drug Application (ANDA) for Ketoconazole Shampoo, 2%.
- The product is a generic version of the reference listed drug Nizoral.
- U.S. annual sales for Ketoconazole Shampoo, 2% total approximately $69.2 million.
- The company has launched the product following the approval.
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OncoC4 and AcroImmune announce merger
- OncoC4 will acquire 100% of AcroImmune in an all-stock transaction.
- Merger expands OncoC4’s immunotherapy pipeline and adds IND-ready AI-081, a PD-1/VEGF bispecific antibody.
- Establishes in-house clinical manufacturing capabilities and expands geographical footprint.
- Upcoming milestones include IND filing for AI-081 in Q4 2024 and Phase 2 trials for AI-071 in Q4 2024 and Q1 2025.
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Genialis launches first-in-class biomarker to predict tumor response and clinical benefit to KRAS inhibitors
- Genialis has announced the commercial availability of Genialis krasID, a biomarker algorithm predicting patient response to KRAS inhibitors.
- krasID aids drug development from preclinical phases to clinical trials and market access, enhancing patient selection and combination therapy identification.
- KRAS mutations contribute to 1.6 million new cancer cases annually, with over 65 companies developing around 100 KRASi therapies.
- Genialis krasID uses AI/ML to model biological processes from gene expression, validated on real-world data from NSCLC, CRC, and PDAC patients.
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Laverock Therapeutics advances gene silencing platform and focuses on oncology and genetic diseases
- Demonstrated programmable, tunable, stable, and specific gene silencing across multiple target genes and cell types.
- Achieved proof of concept with concomitant silencing of more than one gene.
- Increased throughput and robustness of platform processes for gene editing and cell line development.
- Focused on developing advanced therapies in oncology and genetic diseases, with potential applications in other therapeutic areas through partnerships.
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