Happy Friday network, Following on from my post last week, wanted to share some more articles I have seen throughout this week. Daiichi Sankyo and AstraZeneca ramp up awareness of ENHERTU during Thursday night football. : https://lnkd.in/eTf6rh4T Eli Lilly and Company gained third FDA approval of immunology product, three years since establishing the speciality area. : https://lnkd.in/e5HbkxB4 10 Clinical trials to keep an eye keep an eye on during the second half of 2024. : https://lnkd.in/egM9iRPf Bristol Myers Squibb terminate partnership with Immatics on Bispecific molceule it picked up in 2021 for $150 million, leaving behind $770 million in milestones. : https://lnkd.in/e4SahhUq ADC developed by Daiichi Sankyo, Merck outperforms chemo in lung cancer trial. : https://lnkd.in/eyisAnXX #pharma #biotech #clinicaltrials #ADC
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PharmaShots Weekly Snapshots recapitulate the highlights of the news covered throughout the week! Here's the weekly highlights of our daily news: Genentech Reports the Acquisition of Regor Therapeutics Group's CDK Inhibitors Portfolio Targeting Breast Cancer Recordati to Acquire Sanofi’s Enjaymo, Enhancing its Rare Diseases Portfolio Prime Medicine, Inc. and Bristol Myers Squibb Join Forces to Develop and Commercialize Various Prime Edited Ex Vivo T-Cell Therapies Johnson & Johnson Highlights the Real-World Study of Erleada (Apalutamide) for Treating Metastatic Castration-Sensitive Prostate Cancer at ECOP 2024 Sanofi and Regeneron’s Dupixent Receives the US FDA’s and NMPA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD) AbbVie Seeks the US FDA’s Accelerated Approval of Telisotuzumab Vedotin (Teliso-V) for Treating Non-Squamous NSCLC Happy Reading! Stay Tuned! #news #weeklysanpshot #pharma #medtech #biosimilar #biotech #mergerandacquisition #clinicaltrial #digihealth #pharmashots
PharmaShots Weekly Snapshots (September 30 – October 04, 2024)
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Roche has a recently FDA-approved cancer drug called Tecentriq: * It is a PD-L1 inhibitor * PD-L1 is a protein on the surface of cells that acts as an immune checkpoint. * It is found abundantly on cancer cells. * The idea behind a PD-L1 inhibitor is that by removing the function of PD-L1, immune cells will stop perceiving cancer cells as "self" cells and instead attack. * Essentially, this is an immunotherapy approach Merck just had a promising phase 3 trial with their drug Keytruda * keytruda inhibits PD-1 (not to be confused with PD-L1). This is a protein on the surface of T cells that when bound to PD-L1 tells the T cell not to attack the cell. * Normally it has been administered via IV, but now it looks like it can be injected subcutaneously, which is awesome https://lnkd.in/d97qKvGK.
Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda
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**Only put off until tomorrow what you are willing to die having left undone** **Roche Ramps Up Breast Cancer Pipeline With Regor's CDK Inhibitors** Roche, a leading healthcare company, has recently announced an exciting asset purchase agreement with clinical-stage biotechnology company Regor Therapeutics. As part of this agreement, Roche's Genentech will acquire Regor's portfolio of next-generation CDK inhibitors, which hold immense potential for the treatment of breast cancer. The announcement was made at Roche's Pharma Day, emphasizing the company's commitment to advancing cancer treatment options. This strategic move not only strengthens Roche's position in the field of breast cancer research but also demonstrates its dedication to improving patient outcomes. Year to date, Roche's shares have experienced a remarkable 10.3% gain, showcasing investors' confidence in the company's innovative solutions and continued growth potential. Investing in healthcare, particularly in cutting-edge treatments like CDK inhibitors, aligns with the goals of individuals seeking to grow their Health Savings Account (HSA) while making a positive impact on society. Don't miss out on the opportunity to invest in companies driving breakthroughs in healthcare. By taking action now, you can secure your financial future while contributing to advancements in life-saving treatments. Act today and unlock the potential for growth and wellness for yourself, your family, and the world. 📈💪✨ #hsa #investing #healthcare #health #family #wellness
Roche Ramps Up Breast Cancer Pipeline With Regor's CDK Inhibitors
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Medicus Pharma Ltd. (TSX-V:MDCX) announced that it has received feedback from the US Food and Drug Administration (FDA) on its Phase 2 clinical protocol to non-invasively treat basal cell carcinoma, a type of skin #cancer, using its microneedle #technology. Earlier in 2024, the company submitted to the FDA its Phase 2 Investigational New Drug clinical protocol to treat basal cell carcinoma using micro-array needles containing doxorubicin (D-MNA). The proposed 60-patient, multi-center study will evaluate the efficacy of two dose levels of D-MNA compared to placebo in patients with a nodular type of basal cell carcinoma. The patients will be randomized into three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. More at #Proactive #ProactiveInvestors http://ow.ly/46UH105mOvg #TSXV #MDCX
Medicus Pharma receives FDA feedback on Phase 2 study protocol for skin cancer treatment
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GSK's ADC Receives Breakthrough Therapy Designation for Lung Cancer GSK's investigational drug, GSK5764227 (GSK'227), has been granted breakthrough therapy designation by the FDA for treating relapsed or refractory extensive-stage small-cell lung cancer (ES-SCLC). This designation will expedite the drug's development and review, potentially allowing for earlier market access. ES-SCLC is an aggressive form of lung cancer with limited treatment options. GSK'227 is being studied as a potential new treatment for patients who have progressed or relapsed after standard therapies. Breakthrough therapy designation is granted to drugs that show substantial promise in treating serious conditions. This designation provides several benefits, including increased interactions with the FDA and potential for accelerated approval. GSK'227 is currently being evaluated in a Phase I/II trial and shows promising early results. The company aims to start global trials in the second half of the year. #breakthroughtherapy #oncology #lungcancer #clinicaldevelopment #medicalaffairs https://lnkd.in/ePKCaEdQ
GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status
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In February three FDA approvals received a lot of attention from HCPs. The first was the BioTherapeutics Inc. first cellular therapy to treat patients with unresectable or metastatic melanoma. The second was AstraZeneca's Tagrisso (osimertinib), for patients with EGFR-mutated non-small cell lung cancer and lastly, the third was Genentech's Xolair (omalizumab) injection to help reduce allergic reactions to multiple foods after accidental exposure. Read what HCPs say about these new treatments via the link in the comments. Better listening for better health. https://bit.ly/49aDMSp #pharmaceuticals #healthcare #medicine
Product Launch Tracker: eHCPs are enthusiastic about the first cellular therapy for advanced melanoma.
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$LTRN "Receiving a second #FDA #FastTrack Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma (NASDAQ: LTRN). "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices." About TNBC and the Need for Novel Therapies #TNBC represents approximately 20% of all #breastcancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years. https://lnkd.in/gSw5P--s
Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)
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AnHeart Therapeutics, a clinical-stage leader in cancer precision therapies, and Innovent Biologics, experts in high-quality medicines, have made a significant leap forward in the fight against lung cancer. The Centre for Drug Evaluation of China's NMPA has accepted a second NDA for taletrectinib, positioning it as a pioneering first-line treatment for ROS1-positive non-small cell lung cancer. This marks a milestone for patients who are at the onset of their treatment for locally advanced or metastatic ROS1-positive NSCLC and have not yet been treated with ROS1 TKIs. This acceptance follows on the back of taletrectinib's first NDA and the promising results from the Phase 2 TRUST-I trial.🧬 Having presented interim analysis data at the European Lung Cancer Congress last year, anticipation builds as we await further insights at an upcoming 2024 medical meeting. The medical community buzzes with optimism with Professor Caicun Zhou of Shanghai Pulmonary Hospital reflecting on the need for improved treatments. We are witnessing the potential dawn of a new era in the management of advanced NSCLC. 🤝 #AnHeartTherapeutics #InnoventBiologics #CancerResearch
AnHeart Therapeutics and Innovent Announce China’s NMPA has Accepted Second New Drug Application for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer
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Ahead of an advisory committee meeting scheduled for Thursday, FDA staffers have raised concerns of overtreatment with AstraZeneca’s Imfinzi in its Phase III study in non-small cell lung cancer. In a joint briefing document with the pharma, the regulator’s internal reviewers noted that AstraZeneca’s approach of giving Imfinzi perioperatively—both before and after surgical resection of the tumor—could have exposed patients to excessive levels of immune checkpoint inhibitors. The FDA’s Oncologic Drugs Advisory Committee will meet on Thursday to review the “high uncertainty around the contribution of phases,” especially the need for adjuvant Imfinzi on top of neoadjuvant chemoimmunotherapy. #biotech #biopharma #pharma #NSCLC #Imfinzi #Adcomm
FDA Flags Potential ‘Overtreatment’ for NSCLC With AstraZeneca’s Imfinzi Ahead of Adcomm
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