Earlier today, Neurocrine Biosciences announced the FDA's acceptance of 2 New Drug Applications for crinecerfont in the treatment of children, adolescents, and adults with classic congenital adrenal hyperplasia. According to the company, the NDAs have received Priority Review designations and been assigned a PDUFA date in December 2024. https://lnkd.in/e4GFrPs5 #Endocrinology #FDANews
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SCFHS certified pharmacist👨🏻⚕️ || Hodophile 🌍 || Rotaractor ⚙️ || Medical Content Creator📝 || Sports Enthusiastic ⚽️ 🏏
📍 #Linezolid is a class of antibiotics used to treat gram positive #bacterial #infections. It can be taken orally or given intravenously, and works by targeting the bacterial 50S ribosomal subunit, ultimately inhibiting bacterial protein synthesis and growth. It belongs to class of #antibiotics called #oxazolidinones. 📍 Linezolid is used for treatment of Infections caused by: Streptococci, Staphylococci, including #MRSA, Enterococci, including VRE, Mycobacteria and Anaerobic bacteria. 📍 #Sideeffects of linezolid include neurological symptoms like headache, dizziness, and optic neuritis; gastrointestinal disturbances like nausea, vomiting, and diarrhea; as well as more severe effects like #myelosuppression, #lacticacidosis, #serotoninsyndrome, #hypoglycemia and hypertensive crisis. 📍 Oxazolidinones are #contraindicated in clients with uncontrolled hypertension, as well as in those who are currently taking MAOIs, serotonergic agents, or other medications that can raise blood pressure. Linezolid is also #contraindicated in seizures, gastrointestinal or renal disease, pregnancy and breastfeeding. ⛔ Check out my detailed video about "clinical pharmacology of linezolid": https://lnkd.in/d9tCHAtE 🟢 For amazing clinical pearls, you can join my WhatsApp group: 👇🏻 https://lnkd.in/d3axttDk 🔴 You can also follow me on "YouTube and Instagram" as well: YouTube👉🏼: https://lnkd.in/d4Fx3vCr Instagram👉🏼: https://lnkd.in/dy6krB4q #antibiotics #antibiotic #antibioticstewardship #antibioticresistance #linezolid #pharmacology #pharmacologylectures #medicaleducation #pharmacyeducation #nursingeducation #NAPLEX #usmle #meded #clinicalpharmacology #youtubelearning
Antibiotics pharmacology, linezolid pharmacology, oxazolidinone pharmacology, pharmacology made easy
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Aspiring Pharmacovigilance and Drug Safety Professional || Proficient in ICSR Case Processing, MedDRA Coding & Labelling Assessment || Talks about Life Sciences||
Just came across an exciting FDA approval today! The FDA has approved Yorvipath (palopegteriparatide) of Ascendis Pharma for adults with #hypoparathyroidism—a #rare condition often resulting from surgery or autoimmune disease. This new treatment option is specifically for adults with hypoparathyroidism (but not for those with acute post-surgical hypoparathyroidism). It's a condition where the parathyroid glands don't produce enough parathyroid hormone (PTH), leading to low calcium levels in the blood. Patients usually need active vitamin D and calcium, sometimes in large, frequent doses, to keep their calcium levels stable. Yorvipath's effectiveness was tested in a 26-week trial with 82 participants. Here's the kicker—69% of patients on Yorvipath maintained normal calcium levels without the need for high doses of calcium or active vitamin D. Compare that to just 5% in the placebo group! But it's not without risks. Yorvipath comes with warnings, including potential changes in calcium levels, a risk of #osteosarcoma (observed in rats), and interactions with certain heart medications like digoxin. This drug has received orphan drug designation and underwent a priority review, reflecting its significance for this rare condition. Read more : https://lnkd.in/dZ9gQaKi #FDAApproval #Yorvipath #Hypoparathyroidism #RareDisease #OrphanDrug #PharmaNews #Biotech #ClinicalTrials #PatientCare #HealthcareInnovation #DrugSafety #Pharmacovigilance #Endocrinology #CalciumRegulation
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In a 12 to 0 vote, the #FDA’s Oncologic Drugs Advisory Committee (ODAC) decided that evidence supported that minimal residual disease (#MRD) could be used as an accelerated approval #end_point in clinical trials of #multiple_myeloma. The strength of evidence required for a surrogate end point is based on biological plausibility of the relationship, demonstration of the prognostic value of the surrogate end point for the clinical outcome, and evidence from clinical trials that treatment effects on the surrogate end point correspond to effects on the long-term clinical outcome. MRD fulfills all these criteria in multiple myeloma. https://lnkd.in/er7AVEPi
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Check out insights from HCPLive recent interview with John Browning, MD, where he discusses the potential approval of Tapinarof for Atopic Dermatitis. Browning's discussion on trial data and FDA's nod for tapinarof's supplemental new drug application sheds light on promising strides in eczema treatment. Watch the interview to explore how this novel cream, backed by robust trial findings, could revolutionize care for adults and children. #Tapinarof #AtopicDermatitis #EczemaTreatment #MedicalInnovation Dermavant Sciences
Discussing the Potential Approval of Tapinarof for Atopic Dermatitis with John Browning, MD
hcplive.com
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Assistant Professor at Centurion University of Technology and Management | Gold Medalist in M.Pharm | RIPS, Berhampur | PhD in Pharmacology | Content Writer | Manuscript Services
📢 Excited to share our latest research publication! 🌱🧬 Our article titled "Evaluating maternal toxicity induced by aqueous extract of Bambusa vulgaris shoot through biochemical, hematological, and histopathological assessment in pregnant rats" has been published in the Advances in Bamboo Sciences journal by Elsevier. This study dives deep into the potential maternal toxicity of Bambusa vulgaris shoot extract, exploring its effects on pregnancy. We conducted comprehensive assessments covering biochemical, hematological, and histopathological parameters, offering new insights into its safety profile and effects during gestation. Link: https://lnkd.in/gY-9PJ9w #Research #BambooScience #MaternalToxicity #BambusaVulgaris #ScientificResearch #AdvancesInBambooSciences #Elsevier #Toxicology #Pharmacology #Science #PregnancyResearch #Histopathology #Hematology #Biochemistry
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https://lnkd.in/gWSyZSFi This book covers the whole gamut of pharmacology including basic principles, brief review of pathophysiology of major diseases, and pharmacological basis of therapeutics. Each chapter opens with a list of contents at a glance. The coverage in the text includes pharmacokinetics, pharmacological actions, mode of action, clinical applications, preparations, dosages, drug interactions, contraindications and adverse effects. At the end of each chapter, study questions as well as references as guide are given for further reading. The level of integrative approach closely matches the needs of medical, pharmacy and dental students. #pharmacology #pharmacologybook #cbspublishers #cbspublishersanddistributors #cbsbooks #cbspharmacology #pharmionics #pharmacoepidemiology #generalconcepts #cbsbooks
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SCFHS certified pharmacist👨🏻⚕️ || Hodophile 🌍 || Rotaractor ⚙️ || Medical Content Creator📝 || Sports Enthusiastic ⚽️ 🏏
📍 Celecoxib belongs to group of medication known as NSAIDs. It is a selective Cox-2 inhibitor drug. Celecoxib is used to treat pain or inflammation caused by many conditions, like different types of arthritis. 📍 It works by inhibiting cyclooxygenase-2 enzyme. It is a hormone which is responsible for prostaglandin synthesis, which is a crucial part of the pain and inflammation pathway. Prostaglandins have a major role in modulating pain, inflammation, and fever. 📍 Clinical indications of celecoxib include Rheumatic arthritis, Osteoarthritis, Acute pain and Dysmenorrhea. 📍 Common side effects include cough, skin rash, sore throat, headache, and gas. More serious side effects: increased bleeding or bruising and liver problems. Celecoxib has a Boxed warning for increased risk for cardiovascular diseases such as heart attack or stroke. 📍 Celecoxib is contraindicated in in patients with Hypersensitivity to this drug, Sulfonamide allergies, and in Pregnancy, especially during 3rd trimester. ⛔ Check out a detailed video about "clinical pharmacology of Celecoxib": https://lnkd.in/dNSkvEqY 🟢 For amazing clinical pearls, you can join my WhatsApp group: 👇🏻 https://lnkd.in/d3axttDk 🔴 You can also follow me on "YouTube and Instagram" as well: YouTube👉🏼: https://lnkd.in/d4Fx3vCr Instagram👉🏼: https://lnkd.in/dy6krB4q #celecoxib #NSAIDs #meded #medicaleducation #nursingeducation #pharmacyeducation #pharmacology #clinicalpharmacology #hospitalpharmacy #youtubevideo #clinicalpearls
NSAIDs pharmacology, celecoxib pharmacology, clinical pharmacology lecture, pharmacology made easy
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Botanical Therapeutic Expert | Founder of CBCeuticals | Pushing Boundaries in Health & | Prophylactic & Systemic Solution Innovator | Researcher and Developer of Wellness Solutions
https://lnkd.in/ef8zetkH through an interesting lens we can begin to see how clinical applications in “animals” such as dogs and cows benefit from phyto cannabinoid compounds. While the data is still limited and minor cannabinoids we’re not the focus here a 2:1 ratio of thc/cbd offered a visual difference in the affected areas of the body as well as having an impact on the personality of the animal from before the therapy to after. I do find it very interesting that something as novel as a tincture derived from a plant can satisfy the same function or similar biological expression as a steroid cycle such we prednisone in the protocol for treatment. while the relationship for THC And CBD is still being largely explored. I would like to see other ratios tested against efficacy. Such as a CBDA, CBDVA, CBG/CBGA for more delicate needs. While dealing with these sensitive cannabinoids presents a challenge for working into finished solutions.
Case report: Cannabinoid therapy for discoid lupus erythematosus in a dog
frontiersin.org
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(Benefit-Risk Management / Pediatric Inflammatory Bowel Disease / NEW US FDA Draft Guidance) Conditions for developing IBD medications for adults and children are different and this may provide the pediatric conditions for those interested. Another view for reviewing this guidance is if you have a GI product under consideration with pediatric obligations, may want to take a peek at this guidance too. Also, an opportunity to post or share some stakeholder comments back to the agency - link to public docket included. #fda #ibd #cder #drugs #cber #biologics #inflammatoryboweldisease #gidrugs #gastroenterology
Guidance for Industry
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Extension Trial Analysis Shows Long-Term Safety, Efficacy of Atogepant in Patients With Migraines: The extension trial of atogepant demonstrated an 8.5-day improvement of monthly migraine days at weeks 13 through 16 and no new safety signals were observed. #finance #pharmacy #lifesciences
Extension Trial Analysis Shows Long-Term Safety, Efficacy of Atogepant in Patients With Migraines
pharmacytimes.com
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