James Luterbacher’s Post

🔬 Latest pharma industry updates 👇 💰 Arsenal Biosciences, Inc. raises $325M for cancer therapies, continuing its collaboration with Bristol Myers Squibb and Roche. ⚖️ U.S. lawmakers to vote newt week on Biosecure Act, which could sever ties between biopharma companies and Chinese firms by 2032. 📊 BioMarin Pharmaceutical Inc. reveals growth plans after layoffs and restructuring, aiming for new drug approvals over the next decade. 💊 Novo Nordisk faces ongoing Ozempic® shortages due to high demand and capacity constraints, expected to persist until late 2024. ⚠️ FDA faces a backlog of nearly 2,000 factory inspections, hampered by staff shortages and increased workload. 💉 Vaxcyte’s pneumococcal vaccine outperforms Pfizer’s Prevnar 20 in trials, boosting shares by 36%. 🧪 Moderna’s experimental mpox vaccine shows greater efficacy in animal models than existing vaccines, with human trials underway. 💰 OrsoBio, backed by Eli Lilly, raises $67M to develop weight loss drugs, advancing beyond GLP-1 therapies. 🔍 Recursion shows safety in mid-stage trials but offers little clarity on the efficacy of its brain malformation drug. 💷 UK government invests £400M with the private sector to establish 18 new clinical trial centers. ❌ Athira Pharma’s Alzheimer's drug fosgonimeton fails to meet primary and secondary trial endpoints, causing shares to plummet by 78%. 🔍 New data shows GLP-1 analogs do not increase suicide risk compared to other diabetes drugs, reassuring for Type 2 diabetes patients. 💉 Emergent BioSolutions' ACAM2000® becomes the 2nd mpox vaccine approved in the U.S., with 50,000 doses donated to African countries. 🏭 Novartis begins constructing 2 new U.S. sites to boost radioligand drug production for cancer therapies. 💔 IN8bio cuts workforce by 49% and suspends glioblastoma development to prioritize other programs. 👁️ U.S. Medicare drug prices for 10 medicines are 2 to 5 times higher than in other high-income countries. ⚖️ The EU’s antitrust ambitions face a setback as the court sides with Illumina over its acquisition of GRAIL. 📈 Hoth Therapeutics, Inc’ HT-001 successfully treats papulopustular eruptions in cancer patients, driving shares up 81%. 🔍 Eli Lilly and Company’s weekly insulin shot matches daily alternatives in controlling blood sugar in diabetics, showing promise in Phase 3 trials. 🏢 Lykos Therapeutics CEO resigns after FDA rejection and 75% workforce cuts. ⚖️ Johnson & Johnson ordered to pay Auris Health, Inc. investors over $1B for failing to meet regulatory milestones after the 2019 acquisition. 🟢 Travere Therapeutics receives FDA approval for FILSPARI to slow kidney disease progression, boosting shares by 11%. 🏭 India’s steps to reduce reliance on Chinese pharmaceutical imports show progress, though challenges remain in competing on scale and cost.

🔬 Latest pharma industry updates 👇 💰 Arsenal Biosciences, Inc. raises $325M for cancer therapies, continuing its collaboration with Bristol Myers Squibb and Roche. ⚖️ U.S. lawmakers to vote newt week on Biosecure Act, which could sever ties between biopharma companies and Chinese firms by 2032. 📊 BioMarin Pharmaceutical Inc. reveals growth plans after layoffs and restructuring, aiming for new drug approvals over the next decade. 💊 Novo Nordisk faces ongoing Ozempic® shortages due to high demand and capacity constraints, expected to persist until late 2024. ⚠️ FDA faces a backlog of nearly 2,000 factory inspections, hampered by staff shortages and increased workload. 💉 Vaxcyte’s pneumococcal vaccine outperforms Pfizer’s Prevnar 20 in trials, boosting shares by 36%. 🧪 Moderna’s experimental mpox vaccine shows greater efficacy in animal models than existing vaccines, with human trials underway. 💰 OrsoBio, backed by Eli Lilly, raises $67M to develop weight loss drugs, advancing beyond GLP-1 therapies. 🔍 Recursion shows safety in mid-stage trials but offers little clarity on the efficacy of its brain malformation drug. 💷 UK government invests £400M with the private sector to establish 18 new clinical trial centers. ❌ Athira Pharma’s Alzheimer's drug fosgonimeton fails to meet primary and secondary trial endpoints, causing shares to plummet by 78%. 🔍 New data shows GLP-1 analogs do not increase suicide risk compared to other diabetes drugs, reassuring for Type 2 diabetes patients. 💉 Emergent BioSolutions' ACAM2000® becomes the 2nd mpox vaccine approved in the U.S., with 50,000 doses donated to African countries. 🏭 Novartis begins constructing 2 new U.S. sites to boost radioligand drug production for cancer therapies. 💔 IN8bio cuts workforce by 49% and suspends glioblastoma development to prioritize other programs. 👁️ U.S. Medicare drug prices for 10 medicines are 2 to 5 times higher than in other high-income countries. ⚖️ The EU’s antitrust ambitions face a setback as the court sides with Illumina over its acquisition of GRAIL. 📈 Hoth Therapeutics, Inc’ HT-001 successfully treats papulopustular eruptions in cancer patients, driving shares up 81%. 🔍 Eli Lilly and Company’s weekly insulin shot matches daily alternatives in controlling blood sugar in diabetics, showing promise in Phase 3 trials. 🏢 Lykos Therapeutics CEO resigns after FDA rejection and 75% workforce cuts. ⚖️ Johnson & Johnson ordered to pay Auris Health, Inc. investors over $1B for failing to meet regulatory milestones after the 2019 acquisition. 🟢 Travere Therapeutics receives FDA approval for FILSPARI to slow kidney disease progression, boosting shares by 11%. 🏭 India’s steps to reduce reliance on Chinese pharmaceutical imports show progress, though challenges remain in competing on scale and cost. #GMP #ANDESBIOTECH #PHARMACONSULTING #COMPLIANCE #LIFESCIENCE #PHARMA #HEALTHCARE

🔬 Latest pharma industry updates 👇 💰 Arsenal Biosciences, Inc. raises $325M for cancer therapies, continuing its collaboration with Bristol Myers Squibb and Roche. ⚖️ U.S. lawmakers to vote newt week on Biosecure Act, which could sever ties between biopharma companies and Chinese firms by 2032. 📊 BioMarin Pharmaceutical Inc. reveals growth plans after layoffs and restructuring, aiming for new drug approvals over the next decade. 💊 Novo Nordisk faces ongoing Ozempic® shortages due to high demand and capacity constraints, expected to persist until late 2024. ⚠️ FDA faces a backlog of nearly 2,000 factory inspections, hampered by staff shortages and increased workload. 💉 Vaxcyte’s pneumococcal vaccine outperforms Pfizer’s Prevnar 20 in trials, boosting shares by 36%. 🧪 Moderna’s experimental mpox vaccine shows greater efficacy in animal models than existing vaccines, with human trials underway. 💰 OrsoBio, backed by Eli Lilly, raises $67M to develop weight loss drugs, advancing beyond GLP-1 therapies. 🔍 Recursion shows safety in mid-stage trials but offers little clarity on the efficacy of its brain malformation drug. 💷 UK government invests £400M with the private sector to establish 18 new clinical trial centers. ❌ Athira Pharma’s Alzheimer's drug fosgonimeton fails to meet primary and secondary trial endpoints, causing shares to plummet by 78%. 🔍 New data shows GLP-1 analogs do not increase suicide risk compared to other diabetes drugs, reassuring for Type 2 diabetes patients. 💉 Emergent BioSolutions' ACAM2000® becomes the 2nd mpox vaccine approved in the U.S., with 50,000 doses donated to African countries. 🏭 Novartis begins constructing 2 new U.S. sites to boost radioligand drug production for cancer therapies. 💔 IN8bio cuts workforce by 49% and suspends glioblastoma development to prioritize other programs. 👁️ U.S. Medicare drug prices for 10 medicines are 2 to 5 times higher than in other high-income countries. ⚖️ The EU’s antitrust ambitions face a setback as the court sides with Illumina over its acquisition of GRAIL. 📈 Hoth Therapeutics, Inc’ HT-001 successfully treats papulopustular eruptions in cancer patients, driving shares up 81%. 🔍 Eli Lilly and Company’s weekly insulin shot matches daily alternatives in controlling blood sugar in diabetics, showing promise in Phase 3 trials. 🏢 Lykos Therapeutics CEO resigns after FDA rejection and 75% workforce cuts. ⚖️ Johnson & Johnson ordered to pay Auris Health, Inc. investors over $1B for failing to meet regulatory milestones after the 2019 acquisition. 🟢 Travere Therapeutics receives FDA approval for FILSPARI to slow kidney disease progression, boosting shares by 11%. 🏭 India’s steps to reduce reliance on Chinese pharmaceutical imports show progress, though challenges remain in competing on scale and cost.

🔬 Latest pharma industry updates 👇 ✅ EU approves Novo Holdings’ acquisition of Catalent Pharma Solutions and sale of 3 production sites to Novo Nordisk. ⚖️ McKinsey & Company fined $650M for helping Purdue Pharma boost opioid sales of highly addictive drug OxyContin. 🤝 AbbVie acquires Nimble Therapeutics for $200M, gaining oral IL-23 blocker to complement Skyrizi®. 🎓 77 Nobel laureates oppose Robert Kennedy Jr’s U.S. health secretary nomination, citing vaccine misinformation and public health risks. ❌ Editas Medicine cuts two-thirds of the workforce after failing to find sickle cell partner; shifts to in vivo focus. 🤝 BeiGene pays $150M for CSPC’s MAT2A inhibitor, expanding its cancer combo pipeline. 💰 Citryll raises €85M to advance therapies for immune-inflammatory diseases. 🦠 Scientists warn of potential avian flu pandemic as certain HxNy strains, like H5N1, gain mutations that could infect humans. 🔬 Amgen’s MariTide® shows 20% weight loss in Phase II obesity trial, matching rivals but with higher dropout rates (11% vs 7%). ❌ BioAge Labs halts obesity drug study combining azelaprag and tirzepatide over safety concerns; shares tumble. 🧠 Chimerix, Inc. plans NDA for dordaviprone in rare brain cancer by year-end; strong data raise share price over 200%. 📈 uniQure surges 110% after FDA agrees on accelerated approval path for Huntington’s therapy AMT-130. 🚫 BIOSECURE Act’s prospects fade after exclusion from defense bill; future passage uncertain. ❤️ NewAmsterdam Pharma Corporation’s obicetrapib shows strong LDL-C reductions, shares up 41%. ❌ CervoMed’s neflamapimod fails Phase 2b in dementia with Lewy bodies, shares drop 79%. 🤝 Chroma Medicine and Nvelop Therapeutics merge to combine epigenetic editing and non-viral delivery tech, raising $75M. 💊 Candel Therapeutics’s CAN-2409 improves disease-free survival in prostate cancer; shares up 68%, plans FDA talks. 🏭 BioMarin Pharmaceutical Inc. invests €60M in Irish plant expansion for manufacturing, QC, and process development labs. 👁️ Eli Lilly and Company’s imlunestrant cuts cancer progression risk by up to 43% in advanced breast cancer trial. ⚠️ Keros Therapeutics halts two dosing arms in lung disease trial after pericardial effusions, shares plunge 73%. 💊 LadRx Corporation restarts FDA approval pursuit for aldoxorubicin in sarcoma via 505(b)(2) path; shares surge 236%. 🏬 U.S. lawmakers propose forcing PBMs to divest pharmacies, aiming to curb conflicts, and higher drug costs. 😷 Congo declares maximum alert over “Disease X” with high mortality; Africa CDC assesses situation on site.

🔬 Latest pharma industry updates 👇 💔 Bristol Myers Squibb cuts about 12 projects and 2,200 jobs in a major $1.5 billion cost-saving drive. 🤝 Ipsen and Skyhawk Therapeutics partner on targeting RNA in rare neurological diseases, with a deal potentially worth over $1.8 billion. 🔬 TreeFrog Therapeutics to produce billions of stem cells for Vertex Pharmaceuticals under a deal potentially worth over €765 million. 💻 Moderna enhances its AI-driven healthcare solutions through an expanded partnership with OpenAI, utilizing its internal mChat system. 💔 Bayer adopts a radical organizational overhaul to save €2 billion by eliminating many middle management positions. 🧐 Global cancer cases among those under 50 have surged by 80% from 1990 to 2019. 🔄 Giovanni Caforio, former CEO of Bristol Myers Squibb, to become chairman of Novartis, taking over in 2025. 📉 Sanofi reports a 14.7% drop in its operating result for Q1 but beats expectations with €2.84 billion. ⛔ Abeona Therapeutics sees a 54% drop in share price following an FDA Complete Response letter. 🧐 The EU faces a €150 million extra cost for its former EMA headquarters in London, negotiating with bankrupt tenant WeWork to minimize impact. 💰 Chiesi Group reports a 10% revenue increase to €3.03 billion in 2023, driven by its rare diseases sector. 💉 Moderna will supply Brazil with 12.5 million doses of its mRNA COVID-19 vaccine as part of the 2024 national vaccination campaign. 💵 Endeavor BioMedicines raises $132.5 million in Series C funding, surpassing initial targets. 🔎 3 Japanese firms Takeda, Astellas Pharma and Sumitomo Corporation form a joint venture to revitalize drug research in Japan. 📈 American companies continue to lead global R&D spending, with U.S. firms investing €533 billion in 2023. 🔎 Sanofi considers selling or spinning off its consumer health division, potentially valued over $20 billion. 📊 Novartis sees a stock surge after Q1 reports exceed expectations. 💊 Eli Lilly and Company acquires a drug plant from Nexus Pharmaceuticals in Wisconsin to boost production of injectable medicines. 🛑 BioMarin Pharmaceutical Inc. discontinues investment in 4 experimental therapies that do not meet commercial or patient impact criteria. 💉 WHO study reveals vaccines saved over 154 million lives in the last 50 years, drastically reducing global and African regional infant mortality. 💊 The European Commission launches a five-year Critical Medicines Alliance to combat drug shortages. 🤝 KKR and Impilo jointly acquire Immedica Pharma AB planning to bolster its orphan drug portfolio and expand into new markets. 🤝 Bristol Myers Squibb contracts Cellares to boost its CAR-T cell therapy production, preparing for increased demand and new market launches.

Catch the latest updates from the pharma industry: Bristol Myers Squibb announces major job cuts, partnerships flourish in RNA targeting and AI healthcare, and notable shifts in leadership and investment strategies mark significant industry movements. Dive into these pivotal changes and strategic collaborations shaping the future of pharmaceuticals. Thank you Nicolas Schmitz for the updates. #pharmaupdates #pharmaindustry #healthcare #futureofpharma

Stories making headlines today in the biopharma industry: Eli Lilly has successfully secured FDA approval for donanemab, now branded as Kisunla, following years of rigorous research and safety assessments. This offers a new treatment option for Alzheimer's patients, aiming to reduce amyloid plaque buildup in the brain, despite modest therapeutic benefits. This approval positions Kisunla as a competitor to Eisai and Biogen’s Leqembi, which also targets amyloid proteins. A recent LEK Consulting survey reveals that 68% of global life science companies are adjusting their operations due to the geopolitical tensions affecting US-China collaborations. Despite increased legal scrutiny, most companies have not severed ties, focusing on compliance and diversification to mitigate risks related to the Biosecure Act. Emergent BioSolutions has updated its contracts with the US government, securing over $250 million to deliver vital countermeasures for anthrax and smallpox, among other threats. This funding underscores Emergent’s pivotal role in public health defense, especially in light of recent operational challenges. London's High Court has rendered a mixed verdict in the patent dispute between Moderna and Pfizer/BioNTech. While the court upheld Moderna’s patent EP949, another patent was invalidated. This partial victory highlights the ongoing complexity of legal battles over mRNA technology, with further appeals likely. New Sumitomo Pharma CEO Toru Kimura plans to optimize the company’s R&D structure, despite potential job cuts. Kimura attributes financial difficulties to the lack of a successor to the antipsychotic drug Latuda and underperformance in North America, though recent restructuring efforts show positive signs. Moderna secured a $176 million contract from BARDA to advance its H5 avian influenza vaccine, aimed at bolstering pandemic preparedness. This funding supports the late-stage development of a crucial pre-pandemic vaccine candidate. Ovid Therapeutics faces challenges after a pivotal trial failure, resulting in layoffs. Despite the setbacks, Ovid is committed to progressing its neurological drug pipeline, highlighting the iterative nature of biotech innovation. Johnson & Johnson and Legend Biotech reported positive results for Carvykti in earlier-line multiple myeloma treatment, demonstrating improved survival rates and potentially expanding therapeutic options for patients with this challenging cancer. Checkpoint Therapeutics has resubmitted its biologics license application for the PD-L1 inhibitor cosibelimab after an initial FDA rejection. The revised filing aims to address previous regulatory concerns, with hopes of approval for this promising immunotherapy candidate. These concise updates shed light on this week's key developments in the biotech and pharmaceutical sectors, offering industry professionals essential insights into the ever-evolving landscape. #pharma #biotech #topstories #biodatastudio

Healthcare & Life Sciences News #4 📑 💊 💊  Pfizer creates a new oncology division, targeting $8B medicines by 2030 after a tough financial year. 🤝 Gilead Sciences announces a $4.3B acquisition of CymaBay Therapeutics for its liver disease drug seladelpar, aiming to expand its portfolio in chronic liver conditions. 💰 Novo Holdings plans to invest up to $7B annually by 2030 in life sciences, expanding beyond its significant holdings in Novo Nordisk and Novozymes. 💰 Novartis invests €500M in Austrian production sites, enhancing manufacturing capabilities in Kundl and Schaftenau. 🏭  Daiichi Sankyo, Inc. invests €1B in German site expansion, aiming to boost cardiovascular disease and ADC production, creating 350 new jobs. 💰 Denali Therapeutics gets a $500M boost from a private investor after a Sanofi-partnered ALS drug trial setback. 💔 Roche to cut 6% of their Pharma Product Development workforce as part of restructuring plans. 🤝 Almirall licenses IL-21 blocking antibody from Novo Nordisk for dermatological conditions, gaining global rights to develop and market the therapy. ✍  AbbVie bolsters its portfolio with a $64 million deal with Tentarix Biotherapeutics, focusing on oncology and immunology. 📊  Eurofins struggles post-COVID test boom, with a 3% revenue drop and a net profit halved. 📉 Moderna narrows annual losses with a surprise Q4 profit, buoyed by cost-cutting measures and deferred revenue from Gavi, the Vaccine Alliance. 📈 LEO Pharma returns to financial health, marking a positive EBITDA for the first time in 3 years, aiming for IPO by 2025. 💰 AbbVie plans a $13 billion corporate bond sale to finance acquisitions. of ImmunoGen, Inc. and Cerevel Therapeutics. 👨💼 Thermo Fisher Scientific cut 8,000 jobs globally in 2023, part of a restructuring plan after a 5% revenue drop. 💉 Takeda partners with Biological E. Limited to boost dengue vaccine Qdenga® production, aiming for 100 million doses annually within ten years. 📈 Johnson & Johnson receives EMA support for broader use of its CAR-T therapy in multiple myeloma, potentially outpacing Bristol Myers Squibb’ Abecma. 💼 Novavax to compensate Gavi, the Vaccine Alliance with up to $475M over five years in a settlement regarding COVID-19 vaccine contract obligations. Make sure to follow and share this post, see you in 2 weeks for a new episode ! ✌

Interesting recent pharma industry news 🏭 Sanofi plans to invest €1.5 billion in its Frankfurt plant, reversing plans to relocate production to France. 🤝 Eli Lilly and Company invests $140 million upfront in Radionetics Oncology, with an option to acquire the company for $1 billion. 🤝 GSK acquires CureVac's mRNA flu and COVID-19 vaccines for €400 million upfront, with potential payments up to €1.05 billion. 💉 Emergent BioSolutions secures over $250 million from the US for strategic stockpile vaccines and treatments. 💸 Beacon Therapeutics raises $170 million to advance its lead eye disease therapy in clinical trials. 💉Moderna secures $176 million from BARDA to develop a bird flu vaccine using mRNA technology. 💰 Cartesian Therapeutics raises $130 million through PIPE financing and reports positive Phase 2b trial results for myasthenia gravis treatment. 🧠 Eli Lilly and Company's Alzheimer's drug Kisunla® gains FDA approval, offering monthly treatment for cognitive decline, priced at $32,000 per year. 🧐 Multinational companies, including GSK, Bayer, and Sanofi, exit Nigeria due to inflation and currency issues. 🔍 The US FTC investigates Teva Pharmaceuticals for patent misuse, aiming to combat inflated drug prices and promote generic competition. 🧬 The "RNA bridge" could revolutionize genome editing, allowing precise genetic code transfers without scars, surpassing CRISPR-Cas9 limitations. 🦟 Valneva receives EU approval for its single-dose chikungunya vaccine, Ixchiq®, with plans to deliver doses by Q4 2024. 💊 AstraZeneca's sipavibart for COVID-19 prevention receives accelerated evaluation from the European Medicines Agency based on positive trial data. 💔 Sumitomo Pharma announces job cuts in Japan, following US reductions, to improve profitability after losing exclusivity on a key schizophrenia drug. 💔 Ginkgo Bioworks, Inc. cuts 158 jobs, aiming to reduce labor costs by 35% after disappointing clinical results. 👨💼 Robert Michael becomes CEO of AbbVie, succeeding Richard Gonzalez, who now chairs the board. 📊 China leads in future tech investments, outpacing Western democracies in biotech and AI, driven by substantial government subsidies. 🧠 Annovis Bio, Inc.'s Parkinson's drug buntanetap succeeds in late-stage trials, improving motor and cognitive functions, leading to a 38% stock rise. 🏢 Germany adopts a new medical research law, allowing private drug price negotiations, aiming to accelerate market access for innovative products. ⚖️ Novo Nordisk limits Wegovy® launch in China to avoid supply disruptions globally with its current limited production capacity. ❌ Eisai US and Bristol Myers Squibb end their cancer ADC partnership due to portfolio prioritization.

It was a delight to moderate a stimulating panel discussion on “Leadership and Innovation in Pharma”. This DCT series, organized by AKT Health Inc. in collaboration with the Boston Global Forum and AI World Society (AIWS) -https://aiws.net/, explored key paradigm shifts in R&D strategies and future-proofing the medical value of drugs in development. Key Highlights & Take Aways Panelists:   Uli Stilz, Head of Bio Innovation Hub, Novo Nordisk Roberto Araujo, Global Head of Medical Evidence Generation for Rare Disease, Sanofi Shaju Backer, SVP, Global Head of Immunology Franchise, Sanofi Organizers: David A. Hall, Fion Liao from AKT Health Inc. Pharma leadership must reorient its focus on innovation with an "end-in-mind" approach that directly links to real-world unmet needs. Too often, innovation is confined to mechanistic advances, when in reality, it’s the sophistication in clinical development that enables meaningful real-world impact for any drug. There remains a herd mentality in drug development, leading to too many “me-too” drugs that offer only incremental innovation. The success of GLP-1 agonists (anti-obesity drugs) underscores the importance of balancing quality vs. quantity. Substantial human/financial capital must be invested in new MOAs and pathways—backed by profound translational science and market realities. A truly innovative drug has 1) considerable differentiation from the competition, 2) Highly clinically meaningful effect sizes, and 3) Patient-centric focus, with fit-for-purpose label-grade Patient Reported Outcomes (PROs). Despite billions invested in oncology drug development over the last decade, we still see many cancer drugs yielding 2-3 months of OS difference. More than half of cancer drugs granted accelerated approval in the last decade even failed to show survival benefits in confirmatory studies (1). An analysis of 50 U.S. prescription drugs from all areas revealed significant disparities between forecasted and actual sales during the first five years post-approval (2). With fast changing Reimbursement Dynamics in the US and EU’s HTA regulation on Joint Clinical Assessment (JCA) in place, its imperative that future drugs meet critical standards for differentiation and innovation. Today, RWE, Digital Health, AI, Health Economics, & PROs have become pillars of any innovative clinical development strategy. It’s essential not only to integrate and empower cross-functional SMEs in clinical decision-making but also for R&D leaders to roll up their sleeves and get a granular understanding of these disciplines. Relying on intuition and buzzwords is not enough. Proactive, well-informed strategies are critical for driving both innovation and executional excellence. 1.     Liu ITT, et al. Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval. JAMA. doi:10.1001/jama.2024.2396 2.    https://lnkd.in/egdQdbEX