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***** AstraZeneca/ Daiichi Sankyo’ Enhertu® approved in US as tumor agnostic HER2-directed therapy*****   The US FDA has granted accelerated approval to Enhertu® (fam-trastuzumab deruxtecan-nxki; HER2-directed antibody-drug conjugate) for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment. The accelerated approval is based on data from three Ph2 clinical trials: -Ph2 DESTINY-panTumor02 (https://shorturl.at/rAFG3) -Ph2 DESTINY-Lung01 (https://shorturl.at/dhjzV) -Ph2 DESTINY-CRC02 (https://shorturl.at/otBF9) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The regulatory application was granted priority review by the US FDA. Enhertu® has also been granted Breakthrough Therapy designation for HER2-positive metastatic solid tumors. Enhertu® is now approved in five indications including HER2-positive metastatic breast cancer, HER2-low metastatic breast cancer, HER2-mutated metastatic non-small cell lung cancer, HER2-positive gastric/ gastroesophageal cancer, and HER2-positive (IHC3+) metastatic solid tumors. The prescribing information continues to have boxed warning for interstitial lung disease and embryo-fetal toxicity (if exposed during pregnancy) Enhertu® has been developed and commercialized by AstraZeneca and Daiichi Sankyo in collaboration since March 2019. Sales of Enhertu in the US are recognized by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as alliance revenue in the Company’s financial statements. Source: https://shorturl.at/jkuX1   Stay tuned for more such updates   #astrazeneca #daiichisankyo #cancerresearch #cancer #solidtumors #fda #fdaapproval #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #productmarketing #healthcare #lifesciences #lifesciencesconsulting

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).

More than 94% Vizient, Inc pharmacy program survey respondents reported an impact on pharmacy operations and patient care due to a shortage of crucial oncology drugs used to treat a multitude of cancers. There are currently seven antineoplastic oncology medications in short supply in the U.S. and the lack of information about medication access is exacerbating the shortage. "As an industry, we must look at every link in the supply chain and determine how we can work collectively to improve transparency and the flow of information to quickly and more evenly implement product access and mitigation strategies that help ensure equitable distribution of medications when disruptions occur," says Carina Dolan, Pharm.D, MS., BCOP, AVP, Vizient clinical oncology, pharmacoeconomics and market insights. Access "Evaluating the impact of the oncology drug shortage" white paper to learn more about these shortages and the need to mitigate them. #HealthcareSupplyChain #Oncology #Rx https://viz.inc/44up8D7

EU access to oncology medicines lags behind in the Netherlands In the study, funded by the European Fair Pricing Network (EFPN), time-to-patient access was assessed at the hospital level, including those products that entered markets initially under early access programmes. - https://lnkd.in/dSbVUtrQ #pharma #oncology #medicineaccess #marketaccess

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

Persistent Chemotherapy Shortage Raises Concerns Despite FDA Efforts, National Cancer Group Warns Despite efforts by the White House and FDA to address chemotherapy shortages, a survey by the National Comprehensive Cancer Network (NCCN) reveals ongoing challenges. Among 29 institutions surveyed, 72% report shortages of carboplatin, and 59% face shortages of cisplatin. While most centers can manage by minimizing waste, the situation remains unresolved, impacting smaller clinics and underserved areas. Further work is needed to ensure consistent access to essential cancer treatments, leaving a question mark over the future of chemotherapy supply in the United States. If you're eager to delve deeper into pharmaceutical industry developments and stay informed about the latest news, you need to visit Pharmtales, your source for the Latest Pharma News. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #chemotherapy #drugshortage #nationalcomprehensivecancernetwork #whitehouse #fda https://lnkd.in/dG84xTyg

Excited to share that my latest article on PROTACs in oncology has been featured in the The Economic Times! The global PROTACs market is projected to reach $3.7 billion by 2030. Read more about the future of oncology and the pharmaceutical industry's strides in this space. Out of 39 Phase I-III clinical trials evaluating PROTAC compounds worldwide, only two have reached Phase III clinical trial. #Arvinas is aiming to capture a higher market share by developing several PROTACs, targeting various cancers. Check out the full article here: GlobalData Healthcare https://lnkd.in/eQhWmVWw #Oncology #Pharmaceuticals #PROTACs #cancer #CancerResearch #Biotechnology #Innovation #DrugDevelopment #Healthcare #MedicalResearch #PharmaIndustry #LinkedIn #globaldata #drugdiscovery #TPD #protein

The cancer drug shortage has been a critical issue, with significant impacts on patient care and clinical trials. Crystal Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network® (NCCN®), highlights the primary causes, including manufacturing issues, supply chain disruptions, and regulatory delays. Watch here! #CancerCare #DrugShortage #Oncology #ClinicalTrials #NCCN #Pharmaceuticals

In the latest issue of the Journal of Clinical Pathways, Julie Wiedower, PhDc, CGC, and colleagues analyze the frequency of real-world off-label therapy utilization post–comprehensive genomic profiling via liquid biopsy in precision oncology.   "Despite lacking the endorsement of the FDA, off-label drug use remains a common clinical practice for pharmaceuticals... However, off-label is not synonymous with a lack of evidence supporting efficacy and safety, and in oncology, off-label utilization may be included in best practice guidelines," said the authors.   Read the full report here 👉 https://lnkd.in/egJuGYCR   #JournalOfClinicalPathways #NextGenerationSequencing #PrecisionMedicine #CancerCare #OffLabelTherapeutics

A new study raises questions about the value of a growing trend in cancer treatment: Integration of pharmacies with physician practices. Published in JAMA Network Open, the study examined the outcomes for commercially insured cancer patients whose oncologists had integrated pharmacies, versus those who remained independent. Despite concerns that this model could drive up drug utilization and expenditures, the study found:  - Only a slight increase in oral cancer drug use but no significant change in overall drug spending.  - No discernible benefits for patients in the form of lower out-of-pocket costs or improved medication adherence.  - The percentage of community oncologists with integrated pharmacies quadrupled from 2012-2019. The research team, led by #USCSchaeffer Center expert Genevieve Kanter, notes that financial motives may be driving adoption rather than patient interests.  https://lnkd.in/gBUxsBk2 USC Sol Price School of Public Policy          USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences