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Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of developments that highlight the dynamism and complexity of our industry. The pharmaceutical and biotech sectors continue to evolve rapidly, driven by scientific innovations, regulatory shifts, and strategic initiatives.Eli Lilly's recent move to launch "Employer Connect," a platform aimed at improving access to its obesity medications, marks a significant step in addressing the growing public health issue of obesity. This initiative reflects the increasing influence of employer-driven healthcare solutions in managing chronic conditions. By directly involving employers, Eli Lilly seeks to enhance both the accessibility and affordability of its treatments, which could lead to better patient outcomes and reduced healthcare costs associated with obesity-related complications.In dermatology, Galderma has doubled its sales projections for Nemluvio (nemolizumab), an atopic dermatitis treatment, following a successful market debut. The revised projection to over $4 billion in peak annual sales underscores Nemluvio's strong market performance against competitors like Dupixent. This success not only highlights the drug's therapeutic efficacy but also indicates robust market demand for innovative dermatological therapies.Regulatory landscapes remain pivotal in shaping the industry. Vanda Pharmaceuticals' ongoing efforts to expand Hetlioz's label for jet lag treatment have been met with regulatory challenges since 2019. The FDA's response to Vanda's request for a public hearing underscores the complexities involved in navigating approval processes for label expansions. The outcome of such hearings could have broader implications for similar drugs seeking label amendments.Geopolitical dynamics also influence biopharma investments, with Ireland emerging as a stable manufacturing hub amidst global uncertainties. Despite geopolitical tensions, U.S. investments continue to flow into Ireland, highlighting its strategic importance as a location for biopharmaceutical manufacturing and innovation.In oncology, Pfizer is advancing its research and development strategy under Jeff Legos' leadership by leveraging its $43 billion acquisition of Seagen. The aim is to build an antibody-drug conjugate empire while advancing a PD-1xVEGF bispecific drug licensed from 3SBio. This approach underscores Pfizer's commitment to expanding its oncology pipeline through innovative therapies and combination regimens that could potentially transform cancer treatment paradigms.Meanwhile, Merck KGaA faces challenges with declining U.S. sales of Mavenclad due to anticipated generic competition. This situation reflects a broader industry trend where pharmaceutical companies must navigate patent expirations and generic market entries that threaten revenue streams of established products.Leo Pharma's launch of a direct-to-consumer campaign for Anzupgo, targeting hand eczema treatment, signifies the growing role of consumer engagement in pharmaceutical marketing strategies. Such approaches are becoming increasingly important in reaching patients directly.Collaborations remain a key driver of innovation within the industry. Daiichi Sankyo's partnership with German medtech Gaia to commercialize Lipodia—a digital therapeutic for high cholesterol management—illustrates the convergence between digital health technologies and traditional pharmaceuticals.In gene therapy news, uniQure finds itself in a contentious dialogue with the FDA over its Huntington's disease therapy. The debate centers around uniQure's claim that the FDA requested a "sham trial," which the agency denies. This situation underscores regulatory complexities surrounding gene therapies targeting rare diseases.Simultaneously, PepGen faces a partial clinical hold on its muscle wasSupport the show
MS-Perspektive - der Multiple Sklerose Podcast mit Nele Handwerker
Cladribin (Mavenclad, Leustatin, Litak) ist eine Induktionstherapie, die das Immunsystem unterdrückt und bei hochaktiver MS eingesetzt wird. Hier findest Du den Blogbeitrag zum Nachlesen: https://ms-perspektive.de/272-cladribin Cladribin (Mavenclad, Leustatin, Litak) ist eine Immuntherapie aus dem Bereich der Immunsuppressiva, die zur Behandlung von hochaktiver Multipler Sklerose (MS) eingesetzt wird. Es gehört zur Klasse der verlaufsmodifizierenden Therapien, die das Immunsystem durch Depletion gezielt beeinflussen, um das Fortschreiten der Krankheit zu verhindern. Erfahre mehr über das Prinzip der Induktionstherapien, wie Cladribin funktioniert, wie wirksam es ist und welche potenziellen Risiken damit verbunden sind. Du lernst die Rolle von Cladribin in der MS-Therapie kennen, seine verschiedenen Formen und was PatientInnen wissen sollten, wenn sie diese Behandlung in Betracht ziehen, insbesondere im Hinblick auf Schwangerschaft, Stillen und langfristige Gesundheitsüberwachung. Bitte bedenke, dass ich hier nur einen Überblick geben kann. Dein Neurologe und deine MS-Schwester sollten dich ausführlich über die richtige Therapie für dich beraten. Das liegt daran, dass sie deinen allgemeinen Gesundheitszustand kennen und du auch über deine Ziele, Wünsche, Ängste und Vorlieben sprechen solltest, damit diese berücksichtigt werden können. Inhaltsverzeichnis Allgemeine Informationen Wie wird Cladribin (Mavenclad, Leustatin, Litak) bei den Immuntherapien eingestuft? Wofür ist Cladribin (Mavenclad, Leustatin, Litak) zugelassen? Wie sieht die Situation für spezielle Patientengruppen aus? Wer sollte Cladribin (Mavenclad, Leustatin, Litak) meiden? Wie wirkt Cladribin (Mavenclad, Leustatin, Litak)? Wie wird es eingenommen? Wie wirksam ist Cladribin (Mavenclad, Leustatin, Litak)? Risiken und Nebenwirkungen von Cladribin (Mavenclad, Leustatin, Litak) Impfungen Quellen Schlussbemerkung --- Vielleicht möchtest du auch einen Blick auf die Beiträge zu den anderen Immuntherapien werfen: #256: Dimethylfumarat (Tecfidera) und Diroximelfumarat (Vumerity) #258: Glatirameracetat (Copaxone, Brabio) #261: Interferon-beta (Avonex, Betaferon, Extavia, Plegridy, Rebif) #264: Teriflunomid (Aubagio) #266: Natalizumab (Tysabri, Tyruko) #268: S1P-Modulatoren – Fingolimod (Gilenya), Ozanimod (Zeposia), Ponesimod (Ponvory), Siponimod (Mayzent) #270: Alemtuzumab (Lemtrada, Campath) bei hochaktiver Multipler Sklerose Bis bald und mach das Beste aus Deinem Leben, Nele Mehr Informationen und positive Gedanken erhältst Du in meinem kostenlosen Newsletter. Hier findest Du eine Übersicht zu allen bisherigen Podcastfolgen.
Episode 455 Comic Book talk about Count Crowley Amateur Midnight Monster Hunter #3 of 4, Do a Powerbomb! #2, Edgar Rice Burroughs The Land that Time Forgot #1, Equilibrium #1, Gunslinger Spawn #10, King Spawn #12, Moon Knight Black, White & Blood #3, Pink Panther #1, The Three Stooges TV Time Special #1. Multiple Sclerosis Health Talk about Mavenclad, Exercises for overall body benefits, Epstein-Barr Virus and other stuff with health and MS. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. #ms, #multiplesclerosis, #comicbooks, #comicbookreviews --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Episode 453 Comic Book talk about the Living Corpse Relics #1 to 6 of 6, Vampirella #15 & 16, Vampirella versus Purgatory #2 & 4. Multiple Sclerosis Health Talk about Mavenclad and youtube videos along with whatever else we decide to talk about. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Multiple Sclerosis News Today's multimedia associate, Price Wooldridge explains how the safety and efficacy of Mavenclad in a real-world group of RRMS patients, were similar to what was observed in its clinical trials. He also reads “A New Gift Helps Me Stay Cool in the Summer Heat”, by Ed Tobias from his column “The MS Wire.” =================================== Are you interested in learning more about multiple sclerosis? If so, please visit: https://multiplesclerosisnewstoday.com/ ===================================== To join in on conversations regarding multiple sclerosis, please visit: https://multiplesclerosisnewstoday.com/forums/
Episode 384 Wellness Wednesday episode in which we talk about Multiple Sclerosis stuff, Stem Cell Treatments, Mavenclad year two preperations, Foods for a Healthy Gut and more for Multiple Sclerosis Health and MS. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Multiple Sclerosis News Today's multimedia associate, Price Wooldridge, covers how MS patients on Mavenclad are less likely to experience a disease relapse than those on other oral DMTs like Gilenya, Tecfidera, or Aubagio. He also reads “The Double-Edged Sword of Fatigue Medications”, from Beth Ullah's column "Through the Looking Glass". =================================== Are you interested in learning more about multiple sclerosis? If so, please visit: https://multiplesclerosisnewstoday.com/ ===================================== To join in on conversations regarding multiple sclerosis, please visit: https://multiplesclerosisnewstoday.com/forums/
Folge 72: T-Rezept, OTC-Switch und Mavenclad – was gibt's Neues?
Episode 331 Comic Book talk about Vampiverse #5, Darkhawk #5. Multiple Sclerosis Health Talk about characters in Movies and TV with relationships to MS and Mavenclad skin issues and MS. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Episode 249 Comic Book talk about Crisis in Infinite Quarantine one shot, Dark Ages #1, Lester of the Lesser Gods one shot, Red Sonja #1, Sinister War #4, Spawn #321, Suicide Jockeys #1, Technofreak #1, Usagi Yojimo Dragon Bellow Conspiracy #3. Multiple Sclerosis Health Talk about Herbal Supplements and Vitamins. MS update on my Mavenclad experience. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Episode 247 Comic Book talk about Shang-Chi #1 to 5, Shang-Chi vs #1 to 3, Shang-Chi and the Legend of the Ten Rings movie review. Multiple Sclerosis Health Talk about Tips to lose Body Fat, Nutritious Purple Items, Anti-Inflammatory Foods. MS update on my Mavenclad experience. Send comments, questions and tips to kevintheduckpool@gmail.com please help us out by rating and reviewing us and telling a friend. Also check out audio and video versions of Crimson Cowl Comic Club & Under the Cowl podcasts. A fun variety of great people talk comic books, entertainment or whatever and you can see or hear me on many episodes of those podcasts as well with many more great episodes to come out in the future. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
Madison Copot was diagnosed with MS about 9 years ago, just before turning 13. And when she received her diagnosis, Madison was also told that she was too young to be seen by an MS specialist. Today, Madison is a 21-year old young woman, and if you want to hear what a real-life superhero sounds like, you won't want to miss my conversation with Madison. While we're on the subject of superheroes, we'll tell you about Darkhawk, who debuted last week as the first Marvel superhero to be diagnosed with MS. We're sharing the American Academy of Neurology's COVID-19 vaccine guidance. And we have a very specific message to share with anyone living with MS who is still on the fence about being vaccinated. You'll learn about new NIH-funded research that may extend our understanding of how MS happens. We'll also tell you about a clinical trial getting underway in the U.K. that's exploring whether Mavenclad can slow the worsening of hand and arm function in people with progressive MS. And we'll share the line-up of no-cost CAN-DO MS virtual programs taking place throughout the month of September. We have a lot to talk about! Are you ready for RealTalk MS??! Darkhawk returns...and this time, he has MS :22 AAN issues its formal COVID-19 vaccine guidance 2:34 NIH-funded research will examine cell communication in the central nervous system 6:59 CHARIOT-MS clinical trial launches in the U.K. 9:54 CAN-DO MS September programs focus on staying in charge of your life 11:28 My conversation with Madison Copot 13:43 Share this episode 26:52 Download the free RealTalk MS app for your iOS or Android device 27:13 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/209 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com National MS Society COVID-19 Vaccine Guidance for People Living with MS https://www.nationalmssociety.org/coronavirus-covid-19-information/multiple-sclerosis-and-coronavirus/covid-19-vaccine-guidance National MS Society Additional (3rd) COVID-19 Vaccine Dose Guidance for People Living with MS https://www.nationalmssociety.org/About-the-Society/News/Additional-COVID-19-Vaccine-Dose-(Booster)-and-MS Darkhawk (2021) Issue 1 https://www.amazon.com/Darkhawk-1-5-Kyle-Higgins-ebook/dp/B095836W91/ COVID-19 and Vaccination in the Setting of Neurologic Disease: An Emerging Issue in Neurology https://n.neurology.org/content/early/2021/07/29/WNL.0000000000012578 ChariotMS Clinical Trial https://www.mssociety.org.uk/research/explore-our-research/research-we-fund/search-our-research-projects/can-cladribine-slow Can-Do MS September Programs https://www.cando-ms.org/programs Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Androidhttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 209 Guest: Madison Copot Tags: MS, MultipleSclerosis, MSResearch, MSSociety, COVID-19, Marvel, RealTalkMS Privacy Policy
EP230 Comic Book talk about Deadpool Black, White & Blood #1, MFKZ #2, Ravencroft Institute for the Criminally Insane #1, Sinister War #2. Multiple Sclerosis talk about Multiple Sclerosis Sucks Podcast, Vertigo and MS and CBD Infusion with h-patch. I give an update on my Year 1 Week 1 Day 4 of my Mavenclad journey. Send questions, comments, tips to kevintheduckpool@gmail.com and please rate and review us. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
EP229 I lost the internet for a week and here is what I been up to and more. Christina Applegate has been diagnosed with Multiple Sclerosis and we talk about it, what has been happening with me starting up with Mavenclad year 1 week 1. Talk about Suicide Squad 2 and what I thought about it and some other random stuff, I just ramble on from missing podcasting to my masses. Send comments, questions and donations to kevintheduckpool@gmail.com and rate and review us and tell your friends. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
EP217 Comic Book talk about X-Men Evolution #1 to 9. Multiple Sclerosis talk about Mavenclad and MS along with some healthy shopping tips. Send comments, questions and donations to kevintheduckpool@gmail.com and please rate and review us. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
EP211 MS Deep Dive episode about Multiple Sclerosis and Mavenclad. Send questions comments and donations to kevintheduckpool@gmail.com please rate and review on your listening platform. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/kevin-kleinhans/message Support this podcast: https://anchor.fm/kevin-kleinhans/support
In the first Need to Know MS News Update, we discuss two new medications that were recently approved by the U.S. Food and Drug Administration. Information on Mavenclad and Mayzent are available on the National MS Society's website. Prescribing information for Mavenclad and Mayzent is also available via each drug’s website.
If someone is being treated for MS, their neurologist is using the Expanded Disability Status Score, or EDSS, to indicate their level of disability. What if there were a better, easier, and more accurate way to measure mobility and evaluate disability? My guest today is Dr. Valerie Block, a Postdoctoral Fellow in the Department of Neurology at University of California San Francisco. As a physical therapist, Dr. Block is focused on MS rehabilitation. And we're talking about a just-published study that demonstrates that the way neurologists measure disability may not be providing a complete and accurate picture...and there may be a much better way to get that done. We're also talking about a new effort to eliminate the Affordable Care Act and strip away all of its protections for people living with MS and every other chronic illness -- and how the National MS Society and 25 other national patient organizations are fighting back by supporting new legislation designed to strengthen the ACA. We'll tell you about the TWO!!! MS prescription medications that just received FDA approval, and we'll even tell you about yet another MS prescription medication that's now awaiting FDA approval. We have a lot to talk about! Are you ready for RealTalk MS?! ___________ RealTalk MS Reaches a Milestone :26 Join the RealTalk MS Conversation :48 Living with MS? Your Access to Healthcare is Under Attack ...Again! 2:53 Mavenclad Receives FDA Approval for Treating Relapsing-Remitting and Active Secondary Progressive MS 11:37 Siponimod Receives FDA Approval for Treating Relapsing-Remitting and Active Secondary Progressive MS 15:01 Celgene Submits Application for FDA Approval of Ozanimod for Treating Relapsing-Remitting MS 16:41 My Interview with Dr. Valerie Block 19:16 Download the Free RealTalk MS App 34:04 ___________ ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jonstrum@RealTalkMS.comPhone: (310) 526-2283 ___________ LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Download the RealTalk MS App for iOS Download the RealTalk MS App for Android Give RealTalk MS a Rating & Review 26 Patient Groups Support Bill to Stabilize and Strengthen the Affordable Care Act FDA Approves New Oral Treatment for Multiple Sclerosis FDA Approves New Oral Drug to Treat Multiple Sclerosis ___________ Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 84 Hosted By: Jon Strum Guest: Dr. Valerie Block Tags: MS, MultipleSclerosis, MSResearch, ProgressiveMS, Mavenclad, EMDSerono, Siponimod, Novartis, Celgene, RealTalkMS
Caregiving carries a lot of challenges. And for some people, it can feel overwhelming. So, what are the things that make being a caregiver for someone living with a chronic illness like MS so challenging? We're kicking off National Family Caregivers Month with my guest, Dr. Amy Sullivan, Director of Behavioral Medicine, Research and Training at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, and we're talking about how to best navigate some of the challenges that go along with being a caregiver for someone living with MS. We're also talking about today's election in the U.S., and what it means for people living MS, the unresolved status of Ocrevus as a treatment for primary progressive MS in the UK, and the fast-tracking of Mavenclad in the UK. We'll tell you about the bus driver who stood up for a man with MS, an insurance company that will fly people to Mexico and pay a cash bonus to buy their MS prescription medication there, and we'll share results from the Embracing Carers International Survey. We have a lot to talk about! Are you ready for RealTalk MS?! ___________ It's Election Day in the U.S. (and what that means to people living with MS!) :22 The Bus Driver Who Stood Up for a Man with MS 2:49 An Insurer Will Fly People with MS to Mexico to Buy Their Prescription Drugs 4:00 Ocrevus On Hold for People with Primary Progressive MS in the UK 5:49 Mavenclad Fast-Tracked in the UK 7:59 Embracing Carers Campaign & Can Do MS Announce a New Collaboration 9:42 Embracing Carers International Survey Results 10:52 Interview with Dr. Amy Sullivan 12:55 ___________ LINKSIf your podcast app doesn’t allow you to click on these links, you’ll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Download the RealTalk MS App for iOS Download the RealTalk MS App for Android RealTalk MS Congressional Report Card CanDo-MS Embracing Carers Program Recommendations for Cognitive Screening and Management in Multiple Sclerosis Care Give RealTalk MS a Rating & Review ___________ Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 63 Hosted By: Jon Strum Guest: Dr. Amy Sullivan Tags: MS, MultipleSclerosis, MSActivist, DrAmyBSullivan, ClevelandClinic, Caregiving, Caregiver, Ocrevus, Mavenclad, EMDSerono, EmbracingCarers, CanDoMS, RealTalkMS
China’s 3SBio gains a North American through its $290 million purchase of Canada’s Therapure Biopharma Marck’s cladribine tablet Mavenclad achieves sustained control of relapsing multiple sclerosis. A patient enrolled in a CAR-T trial dies. I’m Nestor Arellano. And these are the stories we’ll discuss today on the Biotechnology Focus Podcast. But first, let’s talk about the future of Canada’s life science workplace and workforce +++++ What are the things that employees in Canada’s life science industry value about their workplace? What is it about their organization that keep life science professionals and workers engage and productive each day? How can you, as an employer attract and retain great talent? These are just some of the crucial questions many operators and owners of Canadian life science companies face as they work to grow their business. The key to finding the answers to these questions is data. And the best way to get that data is through the ongoing Biotechnology Focus, Stratford Managers Corporation, and BioTalent Canada nationwide 2017 Life Science Workplace Survey. The poll is one of the most comprehensive attempts to take the pulse Canada’s life science workplace environment. The findings of the survey will provide life science organizations across the country a critical guide on what areas to focus on in order to enhance their operations and relationships with their workers. Don’t miss this chance. There’s still time to take part in the poll. All you have to do is head over to Surveymonkey.com/r/biotechEOS and spend a few minutes taking the poll. Remember that’s surveymonkey.com/r/biotechEOS. Do the survey now and have your say counted. ++++ Early this month, Chinese biotech firm 3SBio Inc., shelled out $290 million For Mississauga, ont’s biologics manufacturer Therapure Biophrama. 3SBio is focused on oncology, nephrology and auto-immune diseases. It has been slowly extending its reach out of its Shenyang headquarters in north China. By purchasing Therapure, 3SBio has effectively put its North American expansion plans into high gear. “3SBio’s global expansion strategy is now on fast track,” according to Dr. Jing Lou, chairman of 3SBio He called the purchase “a key milestone of the global expansion strategy” of his business. The acquisition integrates 3SBio’s mammalian cell culture capabilities and Therapure’s downstream purification and plasma source technologies. This also combines the production capacity of the Chinese company’s recently acquired stakes in Sunshine Guojian Pharmaceutical and Sirton Pharmaceuticals SpA with Therapure’s operations. More than 340 biologics professionals in North America focusing on operations and management, market development, R&D, and manufacturing are expected to join 3SBio. 3SBio will also get certain rights to Therapure’s plasma production and technology, according to the Canadian company. Therapure’s CDMO business will continue to operate under the Therapure brand and be led by Therapure’s CEO Nick Green and the current senior management team at its manufacturing facilities located in Mississauga. +++++ Merck’s Mavenclad branded cladribine tablets for the treatment of highly active relapsing multiple sclerosis has demonstrated the medication a achieve sustained control of the disease over four years with a maximum of only 20 days of oral treatment. The trial, included 806 patients out of 1,184 patients who completed an earlier study. The latest study assessed several clinical efficacy endpoints including annualized relapse rate (ARR) and confirmed three-month Expanded Disability Status Scale (EDSS) progression. ++++ CAR-T therapy has been getting a lot of attention recently. Earlier this month, the FDA gave the green light to Novartis’ CAR-T therapy which uses a patient’s own immune cells to destroy aggressive blood cancer cells. With this method, the patient’s T-cells are collected and sent to a manufacturing centre where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. French biopharmaceutical firm Cellectis was not a fortunate with its own research. The company’s work on an off-the-shelf CAR-T therapy was placed on hold by the United States Food and Drug Administration following the death of one of the patients enrolled in the company’s clinical trial for the therapy. The hold was placed on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML) and in blastic plas macy toid dend ritic cell neoplasm (BPDCN). A 78-year-old BPDCN male patient received a dose of CD123-targeting CAR-T UCART 123 on August 16. Nine days later, the patient died. Another patient treated in the study experienced a similar but less severe reaction. The 58-year-old woman with AML was given the same dose of UCART 123 as the BPDCN patient. Now Cellectis has to determine what precautions to take before moving forward with enrolling more BPDCN and AML patients for the two phase 1 trials it plans. The (Data Safety Monitoring Board) has recommended lowering the dose of UCART123 in both studies to 4g over 3 days. The French biopharmaceutical firm is now working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123. +++++ That’s all the time we have for today. Thank you very much for listening in and I hope you enjoyed our podcast. This is your host Nestor Arellano Inviting you to join us again next week for more biotech news and views on the Biotechnology Focus Podcast.