1315 Capital’s Post

Hello connections, Happy to share #Certificateofparticipation for attending 45th SPSR international webinar on ‘Preclinical Animal Models Studying Neurological Diseases’ organized by Society of Pharmaceutical Sciences and Research (SPSR) on March 24,2024. #SPSR #PharmaceuticalSciences #IJPSR #neurologicaldiseases #preclinical #animalstudy

pHyph is close to market      Gedea Biotech AB Biotech develops pHyph, an antibiotic free vaginal tablet for the treatment and prevention of bacterial vaginosis. The CE-marking process for pHyph is ongoing, estimated to reach EU approval in 2025 and to then be ready for initiating phase 3 trials for US approval as a prescription drug. Gedea aims to close partnerships with larger pharma companies for sales and marketing as well as development for regulatory approvals worldwide of the product. We also have a pipe-line with indications for vulvovaginal candidiasis and pre-term birth. pHyph meets pressing medical needs better than current treatments • Rapid symptom relief   • Long-term effect, low risk of recurrence   • Does not lead to secondary fungal infections   • Double effect in treating both BV and VVC     The company is located in Lund, Sweden. Since its foundation, Gedea has received several prestigious grants and awards, among them Horizon 2020 Grant  and Hoizon EIC 2023 Accelerator. Book a meeting with Annette Säfholm at Bio Europe in Stockholm, November 4-6.  https://lnkd.in/dcSJZtQy #womenshealth #bioeurope

"Thrilled to share that I have received a Certificate of Participation for the 45th SPSR International Webinar on 'Preclinical Animal Models Studying Neurological Diseases.' Grateful for the opportunity to engage with experts in the field and expand my knowledge. Thank you to the Society of Pharmaceutical Sciences and Research for hosting such an insightful event! #ProfessionalDevelopment #NeurologicalResearch #SPSR"

Next stop, #OCTDACH in Zurich! Let’s connect and discuss latest developments in clinical data science. #datascience #clinicaltrials #OCT #biometrics

Laekna Therapeutics receives the US FDA approval for P-III LAE002(Afuresertib) + LAE001 for Clinical trial protocol to treat mCRP #laekna #lae002 #lae001 #afuresertib #clinicaltrials #phase3 #phase2 #prostratecancer #mcrp

USTEKINUMAB First biosimilar in Europe market

J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing After putting on a strong performance in preventing disease progression in the earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti has once again mounted a major benefit—this time in prolonging patients’ lives. A single dose of the star BCMA CAR-T therapy significantly slashed the risk of death by 45% compared with two traditional combination treatments in myeloma patients who had received at least one prior line of therapy, according to an update of the phase 3 CARTITUDE-4 trial. Combinations of either Bristol Myers Squibb’s Pomalyst, Takeda’s Velcade and dexamethasone (PVd), or J&J’s Darzalex, Pomalyst and dexamethasone (DPd) served as the trial's comparators. #pharmaceuticalresearch #drugdiscovery #biotechnology #pharma #healthcar #medicine #science #research #innovation #health

The Australia and New Zealand Sarcoma Association (ANZSA) are using this July to highlight ‘the importance of ongoing #research, funding and clinical trials to advance patient outcomes in the fight against #sarcoma’. QBiotics Group Limited supports the position of ANZSA in raising awareness for one of Australia’s rarest #cancers. We pay our respects to and advocate for those affected by sarcomas. QBiotics recently announced the completion of recruitment of our Phase IIa human clinical trial in Soft Tissue Sarcoma (STS) where we are investigating the preliminary efficacy of our anticancer intratumoural small molecule, tigilanol tiglate, in patients with advanced and / or metastatic STS. QBiotics hopes to be able to report results of the trial in early Q1 CY2025. Completion of trial recruitment follows tigilanol tiglate being awarded Orphan Drug Designation for the treatment of STS by the United States Food and Drug Administration (FDA) earlier this year. You can read more about the work QBiotics and ANZSA are doing in relation to STS on their respective websites below. QBiotics: https://shorturl.at/ZIxRx ANZSA: https://shorturl.at/ueJTd

Genentech, a member of the Roche Group announced today that the United States Food and Drug Administration (U.S. FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options. “Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Today’s approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.” “People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression,” said Natalie Blake, Executive Director of the MS Foundation. “But still, not everyone has access to these medicines. It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential. We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.” #multiplesclerosis #RMS #PPMS #OcrevusZunovo #Genentech #Roche