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?? Wrapping up 2024 with an exciting case study in the pharma domain—and there’s a prize to celebrate the achievement too! ?? ?? Case Study: A Failed 'Potential Blockbuster' in Opioid Management ?? Background: In 2014, a next-gen painkiller was launched to address the growing opioid crisis. Combining a potent analgesic with an abuse-deterrent agent, it aimed to revolutionize pain management by providing effective relief while reducing the potential for misuse. ?? Expectations: Touted as a safer alternative, analysts projected billions in sales, driven by widespread opioid use and regulatory support for abuse-deterrent formulations. ?? Outcome: Despite high hopes, the drug failed to achieve projected sales and was eventually discontinued. ?? Your Turn: Let’s Brainstorm! Q1: What, according to you, were the reasons for this product not becoming a commercial success? Q2: If you were the brand lead, what strategies would you have implemented to ensure its success? ?? Share your insights in the comments below and stand a chance to win! ?? #Win a ?1500 #Amazon Gift Voucher ?? ?? The comment with the most likes (minimum 15 likes to qualify) will be declared the winner! The contest is open for participation until the end of December 25th! Let’s collaborate and learn from this intriguing case! ?? #NMIMS #Casestudy #NIPER #IIHMR #MBA #Strategy

Series: Demystifying Pharma Forecasting Topic: ?? Trending Techniques for Pharma Forecasting ?? Accurate forecasting is critical in pharma to optimize resource planning, inventory, and strategic decisions. Here's a quick breakdown of a few key trending data projection techniques every forecaster should know: 1?? Linear Projection Best for: Products with steady demand growth. Method: Predicts future values based on a constant growth trend (y = mx + b). Tip: Ensure data stability and monitor R2 for accuracy. 2?? Logarithmic Projection Best for: Products with rapid initial growth tapering toward saturation (e.g., new launches). Method: Models growth that slows over time using natural logarithms. Tip: Effective when decline stabilizes or market saturation occurs. 3?? Exponential Projection Best for: Early adoption phases or scenarios of exponential growth/decline (e.g., vaccines). Method: Assumes percentage-based growth proportional to current value. Tip: Avoid when data shows linear trends—may overestimate values. 4?? Holt’s Linear Trend with Damping (Holt’s Decay) Best for: Products nearing maturity with slowing trends. Method: Adds a damping factor to stabilize long-term forecasts while accounting for remaining upward or downward trends. Tip: Ideal for leveling off high-growth products. ?? Bonus: Want a FREE Data Trending Tool to run these and other statistical model based projections in Excel? ?? Drop your email in the comments or email us at: [email protected] ?? Follow Pharma Insights Buddy for expert content and discussions with industry peers. #PharmaForecasting #DataProjection #ForecastingModels #PharmaInsights Content Credit: Molecule Insights

#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 :)