This week PharmaShots’ news was all about the updates on M&A, Pharma, Clinical Trials, Regulatory & MedTech. Check out our full report below: Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Breast06) Study Data of Enhertu to Treat Breast Cancer Read More: Daiichi Sankyo & AstraZeneca                                     Merck Reports Data from the P-III (STRIDE-10) Trial of V116 Pneumococcal Conjugate Vaccine for Adults Read More: Merck            &nb ..read more

Shots: The US FDA has granted fast track designation to the company’s eneboparatide for treating hypoparathyroidism Eneboparatide is being developed under the P-III (Calypso) trial to investigate its safety & efficacy for treating chronic hypoparathyroidism patients (n=165). The topline results are anticipated in 2025 Eneboparatide works by binding with the PTH receptor to stabilize blood calcium levels and reduce urine calcium excretion thus managing the hypoparathyroidism symptoms. It aims at preventing kidney function decline and chronic kidney disease development Ref: Amolyt Pharm ..read more

Shots: The US FDA granted RMAT designation to TSHA-102 based on safety & efficacy results from the first 3 Rett syndrome patients administered with its low dose (5.7x10^14 total vg) under REVEAL P-I/II adolescent/adult and pediatric trial TSHA-102 being evaluated in P-I/II (REVEAL Adult) dose escalation & expansion trial assessing the safety & preliminary efficacy in adult females with Rett syndrome in Canada & US and another P-I/II (REVEAL Pediatric) trial in pediatric females with Rett syndrome in US & cleared in UK TSHA-102 is a self-complementary intrathecal AAV9 gene t ..read more

Shots: Boehringer Ingelheim has collaborated with Walgreens to enhance clinical trial recruitment, aiming for accessibility and inclusivity. The P-III study opportunities will be offered in Walgreens pharmacies The collaboration will utilize Walgreens community pharmacies as study sites for obesity, overweight & type 2 diabetes, thus improving access and addressing equitable health representation in clinical trials. Walgreens will identify and engage patients using advanced, real-world insights BI also teams up with EmVenio Research to introduce mobile research units for better reach and c ..read more

Shots: Remix has recruited and dosed the first patient in two P-I dose escalation & expansion trials assessing the safety, PK/PD & anti-tumor activity of REM-422 to treat recurrent or metastatic adenoid cystic carcinoma (ACC) in one and r/r acute myeloid leukemia/high-risk myelodysplastic syndromes (AML or high-risk MDS) in the other study The US FDA also granted orphan drug designation to the company’s REM-422 for treating ACC and AML REM-422 (oral) is a potent and selective small molecule that reduces MYB mRNA & subsequent protein expression. It triggers nonsense-mediated decay ..read more

Shots: Novartis has agreed to acquire Mariana Oncology to strengthen its radioligand therapy pipeline along with expanding research infrastructure & clinical supply capabilities. The transaction will further support Novartis in oncology & RLT platform innovation Under the acquisition, Mariana will receive $1B up front plus an additional $750M on achieving pre-specified milestones The acquisition also adds diverse RLT portfolio targeting multiple solid tumors like breast, prostate and lung cancer incl. MC-339 (Ac-based RLT) being developed for small cell lung cancer, to Novartis’ pipeli ..read more

Shots:    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency     Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients     During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva. Our team at PharmaShots has summarized 8 key events of the biosimilar space of April 2024    1. Teva Pharmaceuticals ..read more

Shots: Natera has introduced its new cfDNA-based fetal RhD test aiding physicians and patients during Rho(D) immune globulin therapy (RhIg) shortages Natera’s test can be carried out as early as 9wks. gestation from the maternal blood to detect fetal RhD status such as complex pseudogene and RhD-CE-D hybrid variants The launch was supported by a validation study involving 650 RhD-ve pregnancies, confirming fetal RhD status using newborn serology and exhibiting a sensitivity & specificity of 100% & 99%, respectively. The results will be highlighted at ACOG's Annual Clinical & Scient ..read more

Shots: The P-Ib study assesses LTI-03's safety & tolerability vs PBO in IPF patients not previously treated with anti-fibrotic agents for at least 2mos. Cohort 1 evaluated 9 patients in the active arm & 3 in PBO arm who underwent bronchoscopy at baseline, were administered LTI-03 (2.5mg, BID) for 14 days & had bronchoscopy on D14 with 7 days of follow-up The results depicted reduced profibrotic protein expression in pathologic basal-like cells & fibroblasts, decreased levels of GAL-7, TSLP & Col-1α1 biomarkers confirming its ability of fibrosis & inflammation reduction ..read more

Shots: The P-III (ECHO) study investigates the safety & efficacy of Calquence + bendamustine and rituximab vs SoC CT (bendamustine and rituximab) in treatment-naïve MCL patients (n=598, over 65yrs.) in North and South America, EU, Asia and Oceania The interim analysis depicted an improved PFS with Calquence combination regimen vs SoC along with an OS trend favoring the regimen though the OS data was immature during analysis and the study is underway for its evaluation Additionally, Calquence is also being assessed as monotx. and in combinations to treat several B-cell blood cancers such as ..read more