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#Weight #Loss and the #Wonder #Drug (2/n) Unlocking the #Future of Weight Loss: Are #Wegovy, #Zepbound, and Other "Wonder Drugs" the Answer? The buzz around new weight loss medications like Wegovy, Zepbound, and Saxenda is growing—and for good reason. These drugs, initially created for Type 2 #diabetes, have shown incredible promise in helping people shed significant weight. By targeting #hunger #hormones, they make it easier to control cravings and maintain healthier habits. Imagine losing up to 20% of your body weight just by adding the right tool to your #lifestyle routine! But what’s the catch? These medications aren’t one-size-fits-all and they come with their own sets of potential side effects and efficacy. Curious to know which might work best for you or your clients? We’ve put together a detailed presentation below to dive deeper into each medication and how they’re transforming weight loss. Slide through to explore! ?? Novo Nordisk Eli Lilly and Company

?? Understanding EMA Approval Timelines: Key Milestones for Bringing Innovations to Market The journey of a new medicinal product through the European Medicines Agency (EMA) is a structured and well-defined process, but understanding the key timelines and steps is crucial for navigating it successfully. Here's a quick breakdown of what to expect: ?? 1. Centralized Procedure Most innovative therapies go through the centralized procedure, which ensures approval across all EU countries with a single application. From the time of submission, the review process is designed to be completed within 210 active days (excluding clock stops where the applicant responds to questions). The average time from filing to final approval typically ranges from 12 to 18 months, depending on the complexity of the product and any additional information requests. ?? 2. CHMP Opinion One of the most critical moments in the EMA process is the issuance of the CHMP (Committee for Medicinal Products for Human Use) opinion. The CHMP, a scientific body, provides a recommendation based on a thorough evaluation of the product’s quality, safety, and efficacy. This opinion typically comes around day 210 of the procedure. A positive CHMP opinion is a strong indicator that a formal marketing authorization will follow, although the final decision rests with the European Commission. ? 3. Final Marketing Authorization Following the CHMP opinion, the European Commission has up to 67 days to make its final decision, but this is usually expedited. Once granted, the marketing authorization is valid across all EU member states, plus Iceland, Liechtenstein, and Norway. ?? Conclusion From submission to final approval, the EMA timeline is rigorous but clear. The CHMP opinion is a key milestone, signaling that your innovation has passed the scientific scrutiny required for eventual approval. On average, it takes 12 to 18 months to bring your product to market from the initial filing. Interested in receiving an excel file with complete dataset of all drugs under review by EMA and latest info on CHMP review outcome!! Just type “YES” in comments section of this post OR email us at?[email protected] Don’t forget to Follow our Pharma Insights Buddy page and get more informative content, participate in discussion with industry experts and get resolution to your queries by industry peers!! #Pharma #EMA #CHMP #DrugApproval #DrugDevelopment #LifeSciences #RegulatoryAffairs #EMAApproval #HealthcareInnovation #ClinicalTrials #Biotech #PharmaceuticalIndustry #MedTech #HealthTech #MedicalInnovation #EuropeanUnion #RegulatoryPathways #MedTechRegulation

#Weight #Loss and the #Wonder #Drug (1/n) Obesity is a medical condition where excess body fat negatively impacts health. In adults, overweight and obesity are defined as a #BMI ≥25 kg/m2. In children, overweight and obesity are defined as a BMI >1sd above the WHO median child reference values. It’s a complex issue influenced by genetics, environment, lifestyle, and socioeconomic factors, leading to serious health complications like heart disease, diabetes, and certain cancers. Globally, the number of people living with obesity has almost tripled since 1975 and is set to reach over 1.2 billion adults by 2030. ?? Dive deeper into the statistics, causes, and the urgent need for comprehensive action in the slides below. Let’s work together to promote healthier, more active lives! ?? #obesity #wegovy #GLP-1 #Strokes #heartfailure #PublicHealth #ObesityCrisis #HealthMatters #GlobalHealth #Wellness

FDA Approval Alert! Niemann-Pick disease Type C (NPC) disease received first approved treatment in the USA on 20 Sep 2024 with approval of Miplyffa from Zevra Therapeutics. The indication is poised for a market share tussle with another competitor vying for approval, as IB1001 from Intra Bio awaits FDA decision on 24 Sep 2024!! Like and Follow Pharma Insights Buddy for more insightful content and knowledge sharing by the industry experts!! Do you want to share your insights, learnings with like minded audience? Just send your content to [email protected]. Get published, reach beyond network and earn #Amazon_Vouchers if the post receives more than 50 Likes ?? #Post_Credit: Big thanks to Anuj Kumar Rai for the analysis and sharing with PIB community.

Please select a Non-Oncology disease that you believe currently has the most dynamic and innovative pipeline in terms of new drug development and clinical trials, and is likely to soon experience a paradigm shift in its treatment. One #lucky_respondent will win Amazon vouchers! Also, Pharma Insights Buddy will publish a disease landscape report for the most voted therapy area or most mentioned indication in the comments section.

Are you often confused by the complex jargon around Prescription Metrics? Don’t worry! Swipe through Rx Metrics overview and earn to chance to win Amazon vouchers too! ??

FDA data visualizer dashboard has been updated with latest data (17th Sep 2024) FDA Dashboard Link: https://lnkd.in/gFJn8dve For queries, email us at [email protected]

??pssst … I am an intern with PIB, I want to share a secret before they come back!! I heard they have built something. If you are a professional in #Pharma domain #Competitive_Intelligence #Forecasting #Data_analytics #Strategy #Consulting and often access #USA_FDA website for drug #Label then you should read this post :) Now get required info and additional details from a single window! #Interested ? Access Web Report below (Power BI not required to access report) #Report Link: https://lnkd.in/gFJn8dve If you like to access source Power BI file then #Follow Pharma Insights Buddy page --->Like this post --->Provide your email in #comments OR #email us at [email protected] OR #Message us. We will email the the Power BI file. Oh, they are coming back, gotta go. Happy weekend! The Pharma Insights Buddy is an initiative to bring lifesciences peers together as a #community. If you like to collaborate with us to bring more Solutions / Insights / Knowledge Sharing OR share your #Experience #Learnings #Innovative thoughts / #Impactful Insights with curious peers and get #Credit for same then reach out via email ([email protected]), we will get in touch :)

????????????: ???????????????????????? ???????????? ?????????????????????? ?????????? 3: Risk Evaluation and Mitigation Strategies (REMS) A #Risk #Evaluation and #Mitigation #Strategy (REMS) is a drug safety program that the U.S. #FDA may require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. ?????????????? ???? ???????????????? ???? ?????????????????????? ?????????????? ?? ???????? ???????????????? ?? ????????: (A) Estimated size of the #target population (B) #Seriousness of the disease or condition being treated with the drug (C) Expected #benefit of the drug (D) #Duration of treatment (E) Seriousness of any known or potential #adverse events related to the drug (F) Whether the drug is a new #molecular entity Each REMS is unique and may include different elements and tools to mitigate the drug’s risk(s). Listed below are the content areas that a REMS inspection will focus on: 1?? ???????????????????? ??????????: The REMS for a drug may require the sponsor to develop a Medication Guide, which sets forth requirements for patient labeling for human prescription drug products, including biological products. This guide must be made available to patients when the drug is dispensed. 2?? ?????????????????????????? ????????: The REMS for a drug may require the sponsor to develop and implement a communication plan targeted at healthcare providers. 3?? ???????????????? ???? ???????????? ???????? ?????? (??????????): The FDA may require a REMS to include elements necessary to assure the safe use of the drug. An ETASU will address one or more of the REMS goals. ???????????????????????? ???? ???????? ???? ???????????? ??????????????????????: 1. #Market Share Prediction: Drugs under the REMS program behave differently than other drugs, as their distribution is restricted and patients must follow additional procedures to obtain the drug. 2. #Launch Strategy Optimization: REMS can inform launch plans, resource allocation, and marketing strategies. 3. #Generic Entry Post-Patent Expiry (LoE): Any generic drug that mimics a branded drug under REMS must share the same REMS, which makes generic entry more complex after patent expiry. 4. #Analog Analysis: Choosing REMS-approved drugs as analogs only makes sense if your drug is also REMS-approved. Otherwise, the data may be skewed. Thus, REMS is a #critical parameter to consider when developing a forecast for your drug. It can significantly impact your projections if not properly assessed. Pharma Insights Buddy is sharing the ?????????? ???? ?????????????????? with different FDA databases including detailed information?on all ????????-???????????????? ?????????? for our #community members. Provide your email in the comments section or email us at [email protected]. Don’t forget to #follow and #like your Pharma Insights Buddy page for more #informative content and get answers to your #queries from industry peers!

????????????:?#Cancer #Burden and #Epidemiology (1/n) Topic 1: ?????? 10 ???????????? ?????????? ???? ?????????????????? 1. The #incidence of the top 10 Cancer sites makes up almost 63% of all the cancers (35+ specified and Unspecified sites) 2. Lung cancer is the most commonly #diagnosed cancer (12.4% of all cancer incidence) and the #leading cause of cancer death #worldwide (18.7% of all cancer mortality). In absolute numbers, in 2022, almost 2.5 million cases (1 in 8 cancers) and 1.8 million deaths (1 in 5 deaths) were from Lung cancer 3. Five Year #Prevalence of certain types of cancer, #breastcancer for example has increased (around 8.2 million cases) because of better #treatment options and early diagnosis ???????? ?????????? ??????????: - In 2022, approximately 20 million cancer cases were newly diagnosed worldwide. By 2050, the number of cancer cases is predicted to increase to 35 million based solely on projected #population growth - Approximately 9.7 million people died from cancer worldwide in 2022, corresponding to about 26,700 deaths per day - Approximately 1 in 5 individuals will develop cancer in their #lifetime, and 1 in 9 men and 1 in 12 women will die from the disease - In males, lung cancer is followed by #prostate, #colorectal, and #stomach cancers for incidence, and #liver, colorectal, and #stomach cancers for mortality. - In females, #breast cancer ranks first for both incidence and mortality, followed by #lung, #colorectal, and #cervical cancers. ? Pharma Insights Buddy is sharing an #excel containing the incidence, prevalence and mortality rates details (Absolute numbers and Percentages) for 35+ Cancer Sites for our community members. Provide your email in the comments section OR email us at?[email protected] Don’t forget to Follow our Pharma Insights Buddy page and get more #informative content, participate in #discussion with #industry experts and get resolution to your #queries by industry peers!! Also, #Like and #share the post!!