Harriet Wheat

2024 is already shaping up to be a landmark year with groundbreaking FDA approvals. With the first half of the year aimed at cell & gene therapy, the second half of 2024 is equally thrilling with key FDA decisions on the horizon: 🧠 Eli Lilly and Company's donanemab for Alzheimer's - promising better cognitive outcomes. 💪 Adaptimmune’s afami-cel for synovial sarcoma - a potential game-changer in T cell therapy. 💊 Lykos Therapeutics’ MDMA for PTSD - could be the first psychedelic drug approved for a neuropsychiatric disease. 🧬 Bristol Myers Squibb's KarXT for schizophrenia - set to be the first new class in decades. 🎯 Daiichi Sankyo US & AstraZeneca's Dato-DXd for non-small cell lung cancer - aiming to join the elite ADC club. Stay tuned for these exciting developments! 🌟 #Biotech #FDA #Innovation #Healthcare https://lnkd.in/eR998NUX

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Clinical Updates: #BIOSECURE Act gives drug makers until 2032 to sever ties with China. What does this mean for US Pharma? The BIOSECURE Act is a bill in the US Congress aimed at reducing reliance on Chinese biotechnology companies. It prohibits US government agencies and drug manufacturers from working with these firms, which are considered a national security risk. The latest version of the Act includes a grace period until 2032 for drugmakers to find alternative suppliers, acknowledging the challenges of an immediate switch. This could still disrupt existing supply chains and potentially lead to drug shortages or delays in research. What are tyhe possible effects? Here there is a brief summary of what this could mean for the US pharma industry: Disrupted Supply Chains: Many US drug companies rely on Chinese firms like WuXi AppTec for services like manufacturing or clinical trials. Finding new suppliers and building new partnerships will take time and resources, potentially causing delays in drug development and production. Drug Shortages: The transition period may not be smooth, leading to temporary shortages of existing medications that rely on Chinese suppliers. Increased Costs: Finding new suppliers or building in-house capabilities may be more expensive than using established Chinese firms. This could drive up drug development costs and potentially impact drug prices for consumers. Research Delays: Disruptions in ongoing research partnerships with Chinese companies could set back development timelines for new drugs and therapies. Innovation Impact: The US may lose access to some of the expertise and technologies offered by Chinese firms, potentially hindering advancements in the pharmaceutical and biotechnology sectors. https://lnkd.in/e3gvjsUd #medicalaffairs #clinicaldevelopment #medicaljobs #clinicaljobs

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🚀 Immunovant's strategic shift in autoimmune treatment focus! 🚀 Immunovant, a spinout of Roivant Sciences, has announced a pivotal shift in its research priorities. The company will now focus on IMVT-1402, a promising FcRn inhibitor, targeting a range of autoimmune disorders including Graves’ disease. 🧬💡 🔬 Key Highlights: - IMVT-1402: Designated as the lead asset due to positive in-class data. Planned for 4-5 registrational studies in endocrinology, neurology, and more within FY 2025. - Batoclimab: While still important, its prioritization for myasthenia gravis (MG) is being reassessed. Topline results expected within the fiscal year. - Vyvgart: With this shift, argenx’s Vyvgart, FDA-approved for MG, maintains its leading position for now. 🗣️ CEO Pete Salzmann: “We see tremendous opportunity for IMVT-1402, which we believe has a combination of potentially best-in-class features not seen with any other FcRn inhibitor.” 📈 Analyst Insights: William Blair analysts commend the decision, noting the prudence of addressing batoclimab’s LDL lowering concerns and the strategic move to bolster Immunovant’s future in autoimmune treatment. #Biotech #Pharma #AutoimmuneDisease #Research #ClinicalTrials #Innovation #Healthcare #Immunovant #RoivantSciences #FcRnInhibitor #MyastheniaGravis #GravesDisease #MedicalAdvancements #DrugDevelopment

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Clinical Trials Updates: Aurion Biotech receives Breakthrough Therapy and Regenerative Medicine Advanced Therapy Designation in the same day for their ophthalmologic allogeneic Cell therapy Aurion Biotech achieved a significant milestone for its allogeneic cell therapy, AURN001. The FDA granted AURN001 both Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation for treating corneal edema secondary to corneal endothelial disease. This marks a first for AURN001, becoming the first allogeneic cell therapy to receive both BTD and RMAT designations for this specific condition. These designations are crucial as they expedite the development and review process for drugs with promising potential to address unmet medical needs. Corneal transplants, the current treatment option, face limitations due to a shortage of donor corneas and require complex procedures. AURN001 offers a potentially more accessible treatment approach for millions of patients suffering from corneal endothelial disease. The safety and efficacy of AURN001 are currently being evaluated in a Phase 1/2 clinical trial: a multi-centre trial enrolling 97 subjects across the US and Canada. Building on its existing regulatory approval in Japan, Aurion Biotech will leverage these designations to work closely with the FDA and accelerate the development of AURN011. #celltherapy #ophthalmology #raredisease #FDA https://lnkd.in/esTyddGh

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A Future Blockbuster from Arrowhead Pharmaceuticals? Arrowhead's Plozasiran looks poised to become an incredibly effective dyslipidemia treatment, potentially reaching $700M in sales by 2032, according to GlobalData 📊 Targeting the liver protein ApoC3, Plozasiran would fill a crucial gap in the dyslipidemia care market. 🎯 Phase IIb results showed a remarkable 74% reduction in triglyceride levels at 24 weeks, with continued benefits observed at 48 weeks. 📈💡 With Phase III trials underway and FDA Fast Track designation, Plozasiran's approval looks imminent 🌟 #HealthcareInnovation #phaseIIb #biotech #pharmaceuticals #Dyslipidemia #CardiovascularHealth #MedicalBreakthrough #ArrowheadPharmaceuticals 🩺💉

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🌟 Breaking News: Touchlight, CGT Catapult, and Complement Therapeutics Join Forces! 🌟 🚀 Innovative Manufacturing Process for Gene Therapies 🚀 I'm excited to share some groundbreaking news in the biotech industry. Touchlight, Cell and Gene Therapy Catapult (CGT Catapult), and Complement Therapeutics have partnered to develop an advanced manufacturing process for gene therapies. This collaboration has been awarded over £1 million by Innovate UK and aims to revolutionise the production of recombinant adeno-associated virus (rAAV) gene therapies. 📅 Key Highlights: Grant Award: Over £1 million from Innovate UK Objective: Develop innovative rAAV production process using dbDNA™ Collaborators: Touchlight, CGT Catapult, and Complement Therapeutics 🔬 Project Details: Touchlight's enzyme-based DNA manufacturing platform will produce doggybone DNA (dbDNA™), which is significantly faster to produce than traditional plasmid DNA. This innovation aims to increase yield, lower costs, and reduce the environmental impact of manufacturing gene therapies. The dbDNA will be used to produce rAAV, which will then be utilized to manufacture Complement Therapeutics' gene therapy candidates. CGT Catapult will optimize its rAAV manufacturing and analytical platform to support this process, ultimately helping gene therapy developers across the UK. 🗣️ Statements from Leaders: Karen Fallen, CEO, Touchlight: "We are excited to combine our dbDNA technology with those of Complement Therapeutics and CGT Catapult to develop an innovative solution to AAV production. dbDNA has the potential to improve the productivity and thus, the cost of AAV manufacture, while also eliminating bacterial impurities." Rafiq Hasan, CEO, Complement Therapeutics: "We are looking forward to this collaboration in exploring the potential of this innovative dbDNA technology in the manufacture of our AAV gene therapy candidates." Matthew Durdy, CEO, CGT Catapult: "Building on Touchlight’s pioneering dbDNA platform and Complement Therapeutics’ expertise in gene therapies, we hope to develop an innovative process that streamlines viral vector manufacturing and helps to reduce the cost of advanced therapies." 🌍 Impact: This collaboration has the potential to make life-changing gene therapies more affordable and accessible by improving manufacturing processes, increasing yield, and lowering costs. #GeneTherapy #Biotechnology #InnovateUK #Touchlight #CGTCatapult #ComplementTherapeutics #dbDNA #rAAV #HealthcareInnovation #AdvancedTherapies #Biotech #MedicalResearch #LifeSciences

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🦠 Bristol Myers Squibb (BMS) and Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M. Cellares will optimize, automate, and tech-transfer select BMS CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for BMS’ exclusive use. This strengthens BMS’ existing global network of cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets 🦠 Legend Biotech announced that the European Commission has granted approval of CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, have demonstrated disease progression on the last therapy and are refractory to lenalidomide. 🦠 Vertex Pharmaceuticals and TreeFrog Therapeutics announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing technology, C-StemTM, to optimize production of Vertex's cell therapies for type 1 diabetes (T1D). C-Stem™, is designed to mimic the natural microenvironment, allowing cells to grow exponentially in 3D. The technology will enhance Vertex's ability to generate large amounts of fully differentiated cells for its portfolio of T1D cell therapies 🦠 TScan Therapeutics announced closing of upsized public offering. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan. The company intends to use the net proceeds from the offering for general corporate purposes. TScan expects its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. 🦠 SCG Cell Therapy and the A*STAR - Agency for Science, Technology and Research in Singapore launched joint laboratories to advance the development of iPSC technology to produce novel cell therapies that meet GMP standards. The collaboration is supported by $22 million under Singapore’s Research, Innovation and Enterprise 2025 Plan. The joint laboratories leverage SCG’s and A*STAR’s proprietary technologies to develop scalable GMP-grade iPSC and therapeutic products

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Fierce Pharma article forecasts CDMOs to outpace pharma market growth until 2028, as they become indispensable in the evolving therapeutic landscape. Recruitment and investment are key challenges. With over 11 years of experience, N&T can assist with the former, offering expertise in sourcing technical and soft skills crucial for CDMO's success. We've aided global workforce expansion, attracting talent from diverse life sciences sectors to the dynamic CDMO space. https://lnkd.in/eAkVrZ3g

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Clinical Trials Updated: The FDA grants priority review to Tagrisso for specific subtype of NSCLC Straight after ASCO, AstraZeneca's lung cancer drug Tagrisso has received priority review from the FDA for treating unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy. If approved, it would be the first targeted treatment for this condition. Tagrisso showed promising results in a clinical trial, reducing the risk of disease progression or death by 84% compared to placebo. Patients taking Tagrisso had a median progression-free survival of 39.1 months compared to 5.6 months for those on placebo. Safety data was consistent with Tagrisso's known profile. AstraZeneca is seeking a fast-track approval and hopes to establish Tagrisso as a new standard treatment for this type of NSCLC. https://lnkd.in/ewtsc7Xz #oncology #medicalaffairs #clinicaldevelopment #clinicaljobs #medicaljobs

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🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

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Data released in relation to the NOTUS trial, a phase 3 study in COPD, shows positive signs. Not only has the trial met its primary objective, it has also met its secondary endpoint. With a 34% reduction in moderate or severe exacerbations for patients on maximal standard-of-care treatment with a blood eosinophil count (BEC) of 300 cells or greater/µL (per microliter) and with type 2 inflammation, it has also shown improvement in lung function versus the placebo. Edging closer to the FDAs target decision date (27th June 2024) on whether Dupixent will be approved for COPD. #COPD #pharamceuticalnews #sanofi #regeneron

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The latest U.S. Biotechnology Instruments Market report unveils remarkable growth and new opportunities. Here are 10 essential takeaways for every biotech professional: 1️⃣ Market Growth Projections: The market is set to surge from USD 36.16 billion in 2024 to an impressive USD 49.11 billion by 2033, with a CAGR of 3.46%. 2️⃣ Dominance of Analytical Instruments: Analytical instruments, holding a 65.9% market share in 2023, play a vital role in biotechnological applications, from research to quality control. 3️⃣ Rapid Growth in Cell Culture Instruments: The cell culture instruments segment is poised for the fastest growth through 2033, driven by advancements in biopharmaceuticals, regenerative medicine, and personalized healthcare. 4️⃣ Pharmaceutical & Biotech Companies Lead in End-Use: Dominating the end-use segment with a 40.11% market share in 2023, these companies showcase the industry's dedication to drug discovery and genetic engineering. 5️⃣ Rising Investment in Precision Medicine: With expanding applications, precision medicine presents substantial opportunities, boosting demand for biotechnology instruments crucial for genomic sequencing and biomarker analysis. 6️⃣ Regional Innovation Hubs: California and Massachusetts remain strongholds of biotech innovation, with emerging clusters in Texas and North Carolina contributing significantly to industry growth. 7️⃣ Addressing Regulatory Challenges: Navigating regulatory complexities, especially around gene editing and stem cell research, is crucial for sustaining innovation and market growth. 8️⃣ Global Market Size Estimates: The global biotech instruments market is projected to grow from USD 89.85 billion in 2023 to USD 132.36 billion by 2033, at a CAGR of 3.95%. 9️⃣ Recent Product Innovations: 2024 saw notable advancements, including LICORbio's Odyssey® F biomolecular imaging systems and Waters Corporation’s Alliance iS Bio HPLC System, enhancing productivity and research capabilities. 🔟 Impact of Biopharmaceutical R&D: The expansion of biopharmaceutical R&D, focusing on biologic drugs like monoclonal antibodies and cell therapies, is driving increased demand for sophisticated biotechnology instruments. For those looking to stay ahead, these insights provide a roadmap to understanding market dynamics and seizing growth opportunities. Dive into the full report for an in-depth analysis. Procure Complete Report (220+ Pages PDF with Insights, Charts, Tables, and Figures) @ https://lnkd.in/dGry4wGJ #Biotech #MarketInsights #Innovation #PrecisionMedicine #Genomics #Biopharmaceuticals #BiotechInvestments #RegulatoryAffairs #BiotechResearch #MarketGrowth Let's continue to elevate the biotech industry together! 🚀

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𝗗𝗮𝗶𝗹𝘆 𝗡𝗲𝘂𝗿𝗼-𝗯𝗶𝘁𝗲𝘀 🧠: 💵𝘾𝙤𝙣𝙜𝙧𝙖𝙩𝙪𝙡𝙖𝙩𝙞𝙤𝙣𝙨 to CereVasc who secures $70 million series B financing, following FDA approval of STRIDE study 𝗦𝗼, 𝘄𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲𝘆 𝗴𝗼𝗶𝗻𝗴 𝘁𝗼 𝘂𝘀𝗲 𝘁𝗵𝗶𝘀 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗳𝗼𝗿? 🧑‍💻Support the clinical and regulatory development of the company’s novel eShunt system ⚕️Fund their upcoming STRIDE pivotal study involving patients with normal-pressure hydrocephalus. 🤔𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗱𝗼? Their eShunt System is a minimally invasive approach to treating hydrocephalus. The System comprises an endovascularly implantable CSF shunt and associated delivery component. This is designed to avoid the need for: ⭐Invasive surgery ⭐General anesthesia ⭐Extended hospitalization ⭐Post-procedure pain management. #hydrocephalus #brainhealth #minimallyinvasive #patientoutcomes #neurovascular https://lnkd.in/e-R5wkkQ https://lnkd.in/enfjKs_E

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Clinical Trials Updates: The FDA approves ImmunityBio, Inc. immunotherapy therapy treatment for Bladder cancer Bladder cancer, the tenth most diagnosed globally, often manifests as non-muscle invasive bladder cancer (NMIBC), where cancer cells are confined to the bladder lining. Up to 80% of bladder cancer cases fall under this category, which is often treated with Bacillus Calmette-Guérin (BCG). However, some patients do not respond to BCG treatment, necessitating alternative therapies. The FDA has approved ImmunityBio's Anktiva, an IL-15 receptor antagonist, in combination with BCG, to address BCG-unresponsive NMIBC, particularly in cases with carcinoma in situ (CIS) and papillary tumors. Anktiva functions by stimulating the patient's NK cells, CD8+ killer T cells, and CD4+ T helper cells, enhancing the proliferation of memory killer T cells. In simpler words, this therapy aims to activate the body's own immune system to fight the cancer, Approval was based on findings from the QUILT 3.032 trial, showing a 62% complete response rate with Anktiva and BCG combination therapy. Notably, 58% of patients maintained a complete response for at least 12 months, with 40% maintaining it for at least 24 months. Expected to be available in the US by mid-May 2024, Anktiva's approval signifies a shift towards next-generation immunotherapies in bladder cancer treatment. Patrick Soon-Shiong, executive chairman of ImmunityBio, sees this approval as a milestone in advancing treatment options beyond conventional approaches, potentially setting a new standard of care for NMIBC patients. Congrats to ImmunityBio, Inc. for this important milestone! #clinicaltrials #medicalaffairs #clinicaldevelopment #cancer #oncology #clinicaljobs #medicaljobs https://lnkd.in/eDgzmW-K

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🚀 Exciting news from the FDA! Merck's new 21-valent pneumococcal conjugate vaccine, Capvaxive, has just been approved for preventing invasive pneumococcal disease and pneumonia in adults. This innovative vaccine targets strains causing 84% of such diseases and includes eight unique serotypes not covered by existing vaccines, offering significant protection for adults 50+ and seniors 65+. Backed by robust Phase III trials, Capvaxive shows superior immune responses and a comparable safety profile to current options. With this approval, Merck is set to challenge Pfizer's Prevnar 20 in the pneumococcal vaccine market. 🌟 #HealthcareInnovation #Vaccines #FDAApproval #Merck #Capvaxive https://lnkd.in/ewDnUrV3

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The FDA has just approved two biosimilars to Regeneron's blockbuster eye injection Eylea: Biocon Biologics' Yesafili and Samsung Bioepis/Biogen's Opuviz. These biosimilars, designed for conditions like wet age-related macular degeneration and diabetic retinopathy, are set to offer high-quality, affordable alternatives with the FDA's interchangeability designation, meaning they can be used in place of Eylea without needing prescriber consultation. This move underscores the rigorous review process that confirmed these biosimilars' efficacy, safety, and similarity to Eylea. With the potential to lower costs and increase accessibility, biosimilars like Yesafili and Opuviz are poised to be a win for patients. Follow Warman O'Brien for all the latest updates in the life sciences industry. #HealthcareInnovation #Biosimilars #PatientCare #FDAApproval #EyeHealth

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Exciting News in Biotech Collaboration! Bio-Sourcing, a Belgian biotech, has partnered with Afrigen Biologics (Pty) Ltd Biologics, a South African biotech, to launch an innovative pilot program in South Africa called BioMilk. This groundbreaking biotherapeutic platform aims to improve access to essential biotherapeutics, including monoclonal antibodies (mAbs) and insulin products. How can other countries leverage similar collaborative models to enhance their healthcare systems and ensure equitable access to vital medicines? Looking forward to your thoughts and discussions on this exciting development! #Biotech #Collaboration #HealthcareInnovation #BioMilk #BioSourcing #AfrigenBiologics #AffordableMedicine #GlobalHealth

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The Pharma & Biotech industry shows no signs of slowing down. Q2 has started with a series of new investments and acquisitions: Vertex Pharmaceuticals signed a $4.9B deal for Alpine Immune Sciences, Inc., expanding work in kidney and autoimmune disease MSD acquires Abceutics Inc. in deal worth $208m to improve the safety of ADCs FUJIFILM Corporation invests $1.2B in its biotechnological site expansion Contineum Therapeutics announces IPO raising $110M Genmab has agreed to buy ProfoundBio for $1.8 billion Adaptimmune shares drop as Genentech terminates deal once valued at $3 billion Rallybio and Johnson & Johnson collaborate to tackle maternal-foetal blood disorder

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