Latest Healthcare News & Updates: FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment ONO PHARMA USA Finalizes Deal to Acquire Deciphera Pharmaceuticals CHMP Recommends Full Approval for SIRTURO by Johnson & Johnson for Treating Multidrug-Resistant Tuberculosis BeiGene's Tislelizumab Secures European Commission Approval for Non-Small Cell Lung Cancer Therapy Primary Endpoint Achieved in Sanofi's Rilzabrutinib LUNA 3 Phase III Trial for Immune Thrombocytopenia Get more detailed analysis, at: https://lnkd.in/g7Sh3qDF #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch
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Latest Healthcare News & Updates: Acoramidis Joins Bayer’s Robust Lineup, Boosting Cardiology Solutions. AstraZeneca's Datopotamab Deruxtecan Applications Validated In EU For Lung Cancer, Breast Cancer. AbbVie Joins Forces with OSE Immunotherapeutics for Innovative Monoclonal Antibody Targeting Chronic Inflammation. vTv Therapeutics LLC Makes Major Move: Cadisegliatin Heads for FDA’s Phase 3 Study in Type 1 Diabetes. A2 Biotherapeutics, Inc. Scores FDA Orphan Drug Designation for Groundbreaking Cell Therapy Program A2B530 in Colorectal Cancer. Artiva Biotherapeutics Rockets Forward with FDA Fast Track Designation for AlloNK® in Lupus Nephritis. Get a more detailed analysis, at: https://lnkd.in/gma2xEAe #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch
Latest Pharma News and Updates
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🔍 New PharmaBuzz Update 🔎 Navigating the Healthcare Horizon 👨⚕️ The pharmaceutical industry is on the brink of a new era, marked by innovative treatments and strategic advancements. Our latest PharmaBuzz edition covers everything from groundbreaking FDA approvals to the integration of AI in medical research. Discover insights on: 💉 1. Abbvie’s ovarian cancer therapy 2. Dr Reddy’s collaboration with Pharmazz 3. Cadila Pharmaceuticals’ initiative against anemia 4. Theon Pharmaceuticals’ triple-drug formulation for Type-2 diabetes And much more! Stay informed about the transformative developments shaping our health future. Read the full article here: https://lnkd.in/dyS3s7AS #PharmaBuzz #HealthcareInnovation #MedicalResearch #Pharmaceuticals #FDAApproval #AIinHealthcare
PharmaFrontiers: Navigating the New Wave of Healthcare Innovations
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Featured highlights from today's Efortless Update: [Clinical Trials] 「Arvinas Inc. and Pfizer Inc. report phase 1b trial results of vepdegestrant with palbociclib in ER+/HER2- advanced breast cancer showing 63% clinical benefit rate, 41.9% overall response rate, and median progression-free survival of 11.2 months」 「Bayer reports phase III trials of elinzanetant reduce severity of menopausal symptoms and improve sleep, seeking marketing authorizations」 「Genentech's phase Ib trial of CT-388 achieves 18.8% mean placebo-adjusted weight loss in obesity and type 2 diabetes treatment over 24 weeks」 「Ionis Pharmaceuticals, Inc. Pharmaceuticals and Biogen halt development of BIIB105 in phase 1/2 ALSpire study due to lack of neurofilament light chain reduction in ALS」 [Deals] 「Erasca, Inc. inks deals with Joyo Pharmatech and Medshine Discovery for preclinical RAS programs ERAS-0015 and ERAS-4001 with up to $336.5M in milestone payments and royalties」 [Regulatory] 「PharmAust Limited granted Orphan Drug Designation by US FDA for monepantel in Motor Neurone Disease/Amyotrophic Lateral Sclerosis treatment」 「Nuvalent, Inc.'s NVL-655 receives breakthrough therapy designation from FDA for ALK-positive non-small cell lung cancer after two prior ALK inhibitor treatments」 「FDA grants accelerated approval to Amgen's IMDELLTRA for treating extensive-stage small cell lung cancer after platinum-based chemotherapy failure based on DeLLphi-301 trial results」 「Bristol Myers Squibb receives accelerated FDA approval for Breyanzi in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy based on TRANSCEND FL trial results」 View the full newsletter contents for free via the link in the comments.
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Vorasidenib Awaits FDA Approval for Glioma Treatment Following Successful Clinical Trials The European Medicines Agency (EMA) has accelerated its assessment of glioma treatment vorasidenib, which could become the sixth therapy approved for IDH-mutant cancers. The FDA is also expected to make a decision on vorasidenib's approval by August 2024. Data from the Phase III INDIGO trial showed that vorasidenib improved progression-free survival and reduced tumor volume, with a manageable safety profile. The potential breakthrough in treating IDH-mutant gliomas offers hope to patients. For more details please click the link! https://lnkd.in/dsGxDmMs #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
Vorasidenib Awaits FDA Approval for Glioma Treatment Following Successful Clinical Trials
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Exciting developments in the biopharmaceutical industry – Race Oncology Ltd witnessed an 11% stock increase as the FDA awards Rare Pediatric Disease Designation to their drug, RC220 bisantrene. This marks a significant leap forward in pediatric acute myeloid leukemia treatment options.🎗️ Such designations are pivotal in expediting the development of treatments for life-threatening diseases with limited prevalence. The potential of obtaining a Priority Review Voucher upon marketing approval could mean game-changing outcomes for patients and investors alike. R&D in pediatric care gets an impactful boost, providing hope for effective remedies where they're deeply needed. 💡 CEO Dr Daniel Tillett and CMO Dr Michelle Rashford underline the designation's value, emphasizing speedier reviews and rewarding incentives to tackle complex pediatric diseases. Investors, take note: Race Oncology's trajectory is one to watch! 🚀 #RaceOncology #FDAApproval #Biopharmaceuticals #StockMarket #PediatricCancer #MedicalInnovation #AML #HealthcareInvesting Read more about this stride in medical science here: https://lnkd.in/gQbaskeF
Significant Gain for ASX-Listed Race Oncology Following FDA's Favorable Designation
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Last year, the FDA approved a record number of 71 new medicines, with over half targeting rare diseases, 20% dedicated to oncology, and about two-thirds utilizing accelerated approval paths. Vertex achieved a significant milestone with the approval of the first CRISPR-Cas9-cell therapy for sickle cell anemia in late 2023. Additionally, four oligonucleotide-based therapies stood out, including two antisense oligonucleotides from AstraZeneca and Biogen for ATTR polyneuropathy and ALS, respectively, Novo Nordisk's siRNA for Primary hyperoxaluria type 1, and Astellas' RNA aptamer for age-related eye disease. These advancements highlight the diverse progress in pharmaceuticals, providing hope for patients facing various medical challenges. https://lnkd.in/ema532mY).
Fresh from the biotech pipeline: record-breaking FDA approvals - Nature Biotechnology
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2023 was a watershed year in the eight-year journey of FogPharma in its mission to make profoundly impactful medicines. We have developed a new class of peptide therapeutics that can readily address protein-protein interactions, all of which are considered “undruggable” and many of which are key drivers of disease. Our most significant accomplishment in 2023 is the advancement into human clinical development of FOG-001, a long sought-after direct inhibitor of β-catenin:TCF4, the obligate pair known to drive many cancers including colorectal cancer. This pathway is one of the most important in all of cancer. Metastatic colon cancer is uniformly deadly, with no effective treatments currently, and very little in the pharmaceutical pipelines. We are focused squarely on these patients and the great many who face dire futures from Wnt/β-catenin-driven cancers. We also welcomed Mathai Mammen, M.D., Ph.D. as CEO and Chairman in June, as he took the reins from co-founder Greg Verdine. Mathai was previously an executive committee member and global head of pharmaceutical R&D at J&J, where he helped create an industry-leading pipeline and launched eight significant products. Since joining, Mathai has led FogPharma in adding world-class talent to an already excellent team of leaders and company-builders; interweaving a strong product orientation and patient orientation into our robust scientific strategy; doubling down on our moonshot culture; and doubling down on the use of data science to drive our core platform, drug discovery and drug development, making FogPharma a true hybrid tech-life sciences company. We look forward to continuing the momentum in 2024 as we build toward a unique therapeutics company. Check out the video below as we reflect on significant milestones from the last year!
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Latest Pharma News and Updates: AstraZeneca’s Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH FDA Approves Vafseo Tablets by Akebia Therapeutics for Treating Anemia in Adults with Chronic Kidney Disease on Dialysis Bristol Myers Squibb Shares Progress of Phase III YELLOWSTONE Trial with Oral Zeposia in Moderate to Severe Active Crohn’s Disease FDA Greenlights Astellas Pharma’ Supplemental New Drug Application for IZERVAY in Geographic Atrophy Truqap and Faslodex Obtain MHLW Approval for Advanced HR-positive Breast Cancer Therapy Get more detailed analysis, at: https://lnkd.in/g6uzmy5R #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch
Latest Healthcare News & Updates
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Latest Healthcare News & Updates: Alnylam Pharmaceuticals's HELIOS-B Phase III Study of Vutrisiran Shows Positive Results, Meeting All Primary and Secondary Endpoints Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab in Advanced KRAS G12C Colorectal Cancer Japan Approves EZHARMIA® as First Dual EZH1/EZH2 Inhibitor for Peripheral T-Cell Lymphoma Treatment Vertex Pharmaceuticals Reports Encouraging Findings From Phase I/II VX-880 Trial for Type 1 Diabetes at ADA's 84th Scientific Sessions argenx Receives FDA Approval for VYVGART Hytrulo to Treat Chronic Inflammatory Demyelinating Polyneuropathy Get more detailed analysis, at: https://lnkd.in/gQHgvhpT #lifesciences #pharmaceuticals #marketresearch #marketanalysis #healthcare #markettrends #health #medical #news #healthcarenews #pharmanews #clinicaltrials #clinicalresearch
Latest Pharma News and Updates
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R&D, Drug Development & Medical Affairs, Market Access Global Clinical Studies and Product Lifecycle Management, RA, Board of Directors, International Speaker, Development Programs, Strategic Leadership.
Ponatinib, first targeted therapy approved in the US as a frontline treatment for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL). #leukemia #ALLdisease #hematology #patienteducation #fdaapproval #drugapproval #drugdevelopment #pharmaceutical
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Takeda’s Iclusig (ponatinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults who are newly diagnosed with a rare form of leukaemia. The kinase inhibitor, which has been authorised for use alongside chemotherapy, is now the first targeted therapy approved in the US as a frontline treatment for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph-positive ALL). Affecting approximately 25% of adult ALL patients in the US, Ph-positive ALL is characterised by the presence of an abnormal gene known as the Philadelphia chromosome. Iclusig is already approved in the US to treat Ph-positive ALL patients with no other kinase inhibitor options, those with T315I-positive Ph-positive ALL, as well as certain patients with chronic myeloid leukaemia. Takeda’s supplemental application for the drug was supported by positive results from the late-stage PhALLCON study, in which patients received either Iclusig or imatinib plus reduced-intensity chemotherapy. The trial met its primary endpoint, with Iclusig-treated patients achieving a greater than two-fold improvement in the rate of minimal residual disease-negative complete remission at the end of induction. The safety profile of Iclusig was comparable to that of imatinib and no new safety signals were identified. Awny Farajallah, chief medical officer, oncology at Takeda, said: “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline. “We are thrilled that the FDA has recognised the potential of Iclusig to fill a large gap in care for these patients and look forward to seeing the impact this can have on people with this rare and aggressive form of cancer.” Takeda gained access to Iclusig through its $5.2bn acquisition of Ariad Pharmaceuticals in 2017. Read more: https://lnkd.in/gkPEEMFm Stay in touch with all the leading stories, events and opportunities by subscribing to our LinkedIn Newsletter: https://bit.ly/3RbdKtc or joining some of the largest groups most relevant to you: https://bit.ly/4caKquL (A-Z list)
Takeda’s Iclusig combination granted FDA accelerated approval for rare form of leukaemia
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