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Pharma and Biotech Daily: The Latest in Acquisitions, Regulatory News, and Innovative Therapies
Manage episode 461022280 series 3478766
Indhold leveret af Pharma and BioTech News and BioTech News. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af Pharma and BioTech News and BioTech News eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.player.fm/legal.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Johnson & Johnson has made a significant move in the neurology field by acquiring Intra-Cellular for $14.6 billion, gaining access to assets such as Caplyta for schizophrenia and bipolar depression. Biogen has submitted an offer to acquire Sage Therapeutics after facing regulatory and clinical challenges. Gilead is diversifying with a potential $1.7 billion inflammation pact with Leo, focusing on targeting stat6. The FDA's evolving biomarker focus was highlighted by a committee's decision to limit the use of Keytruda and Opdivo in certain cancers based on PD-L1 expression levels. AGC Biologics is offering representative scale-down data for gene of interest candidates before committing to a GMP contract, potentially accelerating timelines by up to 6 months. Other news includes GSK's acquisition of Idorsia targeting rare cancer, AbbVie absorbing the cost of a schizophrenia failure, and collaborations between Merus and Biohaven. Additionally, five novel FDA approvals have been achieved in 2024, while Passage Bio is cutting staff to extend cash runway.The FDA's evolving focus on biomarkers is reflected in the scrutiny of Keytruda and Opdivo for stomach and esophageal cancers based on PD-L1 expression levels. This trend leverages ever-maturing datasets to make more informed decisions about drug approvals. In addition, five novel FDA approvals in 2024 included new mechanisms of action in oncology and neurosciences. Gene therapies for cardiovascular diseases like congestive heart failure and cardiomyopathy are advancing in the clinic, benefiting from technological advancements and positive early data. The NextGen Class of 2025 startups are focusing on ADCs, radiopharmaceuticals, and cell and gene therapies. Pfizer's subcutaneous PD-1 blocker showed positive results in bladder cancer trials, while Denali and AbbVie/Calico faced setbacks in ALS trials. The FDA is proposing setting a bar for weight-loss therapies as the obesity space heats up, with Metsera touting powerful weight loss results.
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65 episoder
Manage episode 461022280 series 3478766
Indhold leveret af Pharma and BioTech News and BioTech News. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af Pharma and BioTech News and BioTech News eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.player.fm/legal.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Johnson & Johnson has made a significant move in the neurology field by acquiring Intra-Cellular for $14.6 billion, gaining access to assets such as Caplyta for schizophrenia and bipolar depression. Biogen has submitted an offer to acquire Sage Therapeutics after facing regulatory and clinical challenges. Gilead is diversifying with a potential $1.7 billion inflammation pact with Leo, focusing on targeting stat6. The FDA's evolving biomarker focus was highlighted by a committee's decision to limit the use of Keytruda and Opdivo in certain cancers based on PD-L1 expression levels. AGC Biologics is offering representative scale-down data for gene of interest candidates before committing to a GMP contract, potentially accelerating timelines by up to 6 months. Other news includes GSK's acquisition of Idorsia targeting rare cancer, AbbVie absorbing the cost of a schizophrenia failure, and collaborations between Merus and Biohaven. Additionally, five novel FDA approvals have been achieved in 2024, while Passage Bio is cutting staff to extend cash runway.The FDA's evolving focus on biomarkers is reflected in the scrutiny of Keytruda and Opdivo for stomach and esophageal cancers based on PD-L1 expression levels. This trend leverages ever-maturing datasets to make more informed decisions about drug approvals. In addition, five novel FDA approvals in 2024 included new mechanisms of action in oncology and neurosciences. Gene therapies for cardiovascular diseases like congestive heart failure and cardiomyopathy are advancing in the clinic, benefiting from technological advancements and positive early data. The NextGen Class of 2025 startups are focusing on ADCs, radiopharmaceuticals, and cell and gene therapies. Pfizer's subcutaneous PD-1 blocker showed positive results in bladder cancer trials, while Denali and AbbVie/Calico faced setbacks in ALS trials. The FDA is proposing setting a bar for weight-loss therapies as the obesity space heats up, with Metsera touting powerful weight loss results.
…
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65 episoder
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1 Pharma and Biotech Daily: Moderna's Losses, RFK Jr.'s Appointment, and More Updates 0:52
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna reported higher-than-expected losses in its fourth-quarter earnings report and is anticipating layoffs. The company's revenue was down substantially from the previous year. Meanwhile, controversial figure RFK Jr. was confirmed as the Health and Human Services Secretary, despite his history of anti-vaccine rhetoric. In other news, BMS' phase III Opdivo and Yervoy combination therapy failed in adjuvant melanoma, potentially limiting market opportunities. Amgen and Ideaya have ended their collaboration on a cancer combo therapy, with Amgen continuing to advance one component in a mid-stage trial for lung cancer. Pliant has brought in outside experts to review a study pause in idiopathic pulmonary fibrosis research. Stay tuned for more updates on various biopharma companies and their developments.…
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1 Pharma and Biotech Daily: Novo's Semaglutide, FDA Job Cuts, Sanofi's Impairment, and More! 0:58
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novo's semaglutide shows promise in curbing alcohol use disorder, according to data published in JAMA Psychiatry. This supports the use of GLP-1 receptor agonists for addictive disorders. Meanwhile, the Trump administration is considering job cuts at the FDA. This could potentially lead to uncertainty and delays in regulatory reviews.In other news, Sanofi is facing a $250 million impairment after scrapping a J&J-partnered E. coli vaccine. Roche's Evrysdi has become the first pill cleared for spinal muscular atrophy. Pfizer has expanded the label for Adcetris to include non-Hodgkin lymphomas.Additionally, Newleos Therapeutics has raised $93.5 million to advance neuropsychiatric drugs from Roche's pipeline. All this information was shared by BioSpace, a platform that provides updates on the biotech and pharmaceutical industry.…
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1 Pharma and Biotech Daily: Your Essential Industry Update 1:16
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Lilly and Novo are leading the pharmaceutical industry with their impressive sales growth of GLP-1 drugs, leaving their competitors in the shadows. Meanwhile, Vir Biotechnology is shifting its focus to immunology following the loss of emergency authorization for its COVID-19 antibody.The shadow market of off-brand versions of GLP-1 drugs is causing regulatory headaches, while Trump's policies continue to impact earnings calls in the pharma sector. Gilead is gearing up for a mid-year launch of lenacapavir, and Novartis has made a major acquisition in a $3.1 billion deal for a blood thinner.In other news, Biogen has secured $250 million from Royalty Pharma for a phase III lupus program, while Lilly is making moves in the mesh and cancer sectors. Inventiva is planning to cut its workforce in half to focus on promising mesh candidates, and Novo executives are working to boost sentiment after a recent error.Stay tuned for more updates in the industry, but remember that job opportunities and other information are always available. For further details, reach out to Annalee Armstrong, senior editor at Biospace. Don't forget to subscribe for a personalized email experience tailored to your preferences.…
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1 Pharma and Biotech Daily: Novartis acquires Anthos Therapeutics, Merck KGaA in talks with SpringWorks, and more! 0:58
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novartis has paid $925 million upfront to acquire Anthos Therapeutics, a company it previously backed in February 2019. This acquisition is part of Novartis' strategy to buy back its drug, a blood thinner, and the entire company. In other news, Merck KGaA is in talks with SpringWorks for a potential acquisition, Lilly has signed deals with Olix Pharmaceuticals and Advancell, and there is a thriving shadow market of GLP-1s for weight loss causing regulatory concerns. Additionally, Vertex is expanding access for JourNavX, Pfizer has positive phase I data for a prostate cancer drug, and Inventiva is halving its workforce to focus on a specific candidate. Boehringer Ingelheim's lung fibrosis drug has scored a second late-stage win, Bain is investing in the Japanese market with a $3.3 billion Tanabe buy, and there is a decline in women leaders in biotech.…
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1 Pharma and Biotech Daily: CAR T Therapy Expansion, Lung Fibrosis Drug Success, and More! 1:14
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Bristol Myers Squibb is seeking to broaden the use of its CAR T cell therapy, Breyanzi, to address marginal zone lymphoma as a strategy to offset losses from exclusivity. In other news, Boehringer Ingelheim has seen promising results in a Phase III trial for its lung fibrosis drug, randomilast, aimed at progressive pulmonary fibrosis. However, Pliant has experienced a stock decline following the halt of its Phase IIb/III study for idiopathic pulmonary fibrosis. Additionally, Vertex has received FDA approval for its non-opioid pain treatment, while AbbVie has secured approval for a new antibiotic. Bain's acquisition of Tanabe for $3.3 billion is also making headlines. Regeneron is currently in a legal battle with Sanofi over the Dupixent pact, and Equillium's itolizumab is undergoing testing against Humira for ulcerative colitis. On the horizon, Acelyrin and Alumis are joining forces to address immune-mediated diseases, while Eisai is seeking subq approval for Leqembi due to sluggish US sales. Job opportunities are available at ATCC, AbbVie, Regeneron Pharmaceuticals, and Dren Bio.…
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1 Pharma and Biotech Daily: The Latest in Industry News and Developments 1:08
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eisai reports lagging sales of Leqembi in the US and is now looking towards gaining approval for a subcutaneous version. Novo Nordisk executives are trying to boost sentiment after the failure of obesity candidate Cagrisema, without providing hard numbers. Regeneron is suing Sanofi for allegedly withholding information about the sales of Dupixent. Nasdaq newcomers Acelyrin and Alumis have merged to focus on immune-mediated diseases. The AAPS National Biotechnology Conference will cover trends in research and biopharma markets.Equillium's Itolizumab is competing with Humira in ulcerative colitis. FDA approval of Vertex's non-opioid Jornavx signals a new era in pain treatment. Novo's bispecific for hemophilia has aced a phase III pediatric trial. Lilly has increased Zepbound supply, prompting analysts to question if it is sustainable. BMS has added $2 billion to cost-cutting plans and is eyeing deals after the success of Cobenfy. AstraZeneca has axed two Alexion assets as Q4 earnings exceed expectations.…
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1 Pharma and Biotech Daily: Key Updates in the Industry 1:11
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eli Lilly CEO David Ricks faced questions about potential oversupply of the company's drug Zepbound. Analysts are concerned that Lilly may have gone too far in expanding the supply chain for its GLP-1 drug. Meanwhile, Bristol Myers Squibb announced plans to increase cost-cutting measures and pursue new deals following the success of its drug Cobenfy. AstraZeneca discontinued two assets acquired from Alexion, despite exceeding Q4 earnings expectations. BMS reported $10 million in sales for Cobenfy in the fourth quarter of 2024.On the other hand, the AAPS National Biotechnology Conference will take place in May, covering trends in research and biopharma markets. X4 Pharmaceuticals and Viracta faced financial struggles, while Kura Oncology eyes FDA filing after a win in AML. Frontier Medicines announced staff cuts, but there is optimism for the job market in January. Pfizer is in discussions for new deals, including potential collaborations in China.Overall, job opportunities are available at companies like Amgen, Takeda, and Novo Nordisk.…
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1 Pharma and Biotech Daily: Navigating the Latest in Industry Trends and Challenges 1:40
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novo Nordisk's drug Wegovy saw a significant increase in sales in 2024, but analysts are still not satisfied and are questioning why the company can't access more patients, especially in the U.S. Despite this success, there is a lack of female leadership in new biotech companies, with only nine out of 102 launches having a woman at the helm. In other news, GlaxoSmithKline is looking to make deals in the cancer, respiratory, and inflammation sectors, while Valerio is facing financial challenges and has had to cut operations. The biotechnology industry is facing a shift towards more data integration and an increase in mergers and acquisitions.Women leaders in biotech are declining as new company founders prioritize CEOs with a proven track record. Out of the 102 most recent company launches or financings, only nine had a woman at the helm. The lack of women in leadership roles in biopharma continues to be a recurring issue. Biopharma companies are investing more in licensing deals to enrich their pipelines with novel therapies, with a focus on combating patent expirations and generics. Despite challenges, such as a shortage of skilled operators, training programs are being emphasized to upskill teams effectively. Some top biopharma licensing deals of 2024 are highlighted, along with updates on various companies' earnings and strategic moves. The Biotech Sisterhood aims to provide fellowship among women leaders in the industry, showcasing a group of women and allies as their authentic selves at events like the J.P. Morgan Healthcare Conference. Additionally, the newsletter includes job listings and opportunities for industry professionals to stay informed and engaged.…
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1 Pharma and Biotech Daily: Your Daily Dose of Important Updates in the Healthcare World 2:25
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Pfizer announces new breakthrough in cancer treatmentPfizer, a leading pharmaceutical company, has recently announced a major breakthrough in cancer treatment. Their new drug has shown promising results in clinical trials, with a significant increase in survival rates for patients with advanced stages of the disease. This development brings hope to millions of people affected by cancer worldwide.## FDA approves new diabetes medicationThe FDA has approved a new medication for the treatment of diabetes. This drug is expected to provide better blood sugar control and improve overall quality of life for patients with the condition. The approval is a significant milestone in the fight against diabetes, which affects millions of people globally.## Biogen partners with research institute to develop Alzheimer's treatmentBiogen, a biotechnology company, has partnered with a leading research institute to develop a new treatment for Alzheimer's disease. This collaboration brings together the expertise of both organizations to tackle one of the most challenging health issues facing society today. The potential impact of this partnership on Alzheimer's research is immense.## Novartis launches new vaccine for infectious diseaseNovartis, a pharmaceutical giant, has launched a new vaccine for an infectious disease that poses a threat to public health. This vaccine is expected to provide protection against the disease and help prevent its spread. The launch of this vaccine is a significant step forward in the fight against infectious diseases worldwide.## Roche acquires biotech startup for groundbreaking gene therapyRoche, a multinational healthcare company, has acquired a biotech startup that specializes in gene therapy. This acquisition will allow Roche to further develop groundbreaking treatments for genetic disorders and other diseases. The synergy between the two companies is expected to lead to innovative therapies that could revolutionize healthcare.## ConclusionIn conclusion, these recent developments in the pharmaceutical and biotech industry are groundbreaking and have the potential to transform healthcare as we know it. From breakthroughs in cancer treatment to advancements in diabetes medication, the future looks promising for patients around the world. Collaborations between industry leaders and research institutes are paving the way for innovative therapies that could have a lasting impact on global health. Stay tuned for more updates on the latest news and advancements in Pharma and Biotech.…
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1 Pharma and Biotech Daily: Trump's Tariffs, Psychedelic Success, and Industry Developments 0:47
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Trump's tariffs are expected to affect the pharmaceutical industry by leading to higher costs and lower margins for companies like J&J, AstraZeneca, Novo Nordisk, and Roche. This could result in financial setbacks for these companies. Meanwhile, GH's inhaled psychedelic has shown success in treating depression, which could provide a new treatment option for patients. In other news, Pfizer's Braftovi has shown promising results in a phase III trial for colorectal cancer, AbbVie's marketing misstep has impacted its aesthetics sales, and Takeda has dropped an epilepsy drug while appointing a new CEO. Overall, the pharmaceutical industry is experiencing various developments and challenges that could impact its future.…
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1 Pain Relief Revolution: Vertex's Journavx Approval and the Future of Non-Opioid Options 1:20
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novartis plans to continue making bolt-on deals in 2025 after a successful year in 2024. AbbVie is regrouping after a mid-stage schizophrenia drug failure. Vertex's non-opioid pain drug has been approved by the FDA. Biotechs are turning to the courts to fight off potential buyers. Other news includes drug pricing under Trump, RFK Jr.'s scrutiny over vaccines, Blackstone's new fund for life sciences, and layoffs at various companies.The FDA has approved Vertex's Journavx (suzetrigine) as the first non-opioid pain signal inhibitor in over two decades. This drug offers patients a non-opioid option for managing acute pain by targeting and binding to the nav1.8 voltage-gated sodium channel. The approval of Journavx comes after Vertex's $7.4 billion opioid settlement and is part of a new wave of medicines aiming to provide effective pain relief without the risks associated with opioids. The FDA's decision was based on positive results from Phase III trials, showing significant improvements in pain scores for patients who had undergone bunionectomy and tummy tuck surgeries. This approval marks a milestone in the development of new pain medications and signals a potential shift towards safer alternatives to opioids for pain management.…
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1 Pharma and Biotech Daily: Stay Informed with the Latest Industry Updates 1:09
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Roche is planning to be cautious with high-priced deals in 2025, prioritizing putting science at the center of its business development decisions. Sanofi's recent earnings were driven by Dupixent and a new RSV vaccine, with a strong focus on R&D and potential M&A deals. Inhibikase has decided to scrap a Parkinson's drug after disappointing mid-stage data, adding to recent setbacks in the field. RFK Jr. faced a divided Senate during his confirmation hearing for HHS secretary, downplaying concerns about his previous anti-vax statements. Vertex is awaiting the FDA verdict on a non-opioid pain drug, while Ironwood has made the decision to cut half of its staff due to disappointing 2025 guidance. Zentalis is planning to lay off 40% of its staff in order to extend its cash runway. The life sciences scene in the Chicago area continues to show growth.In the latest news, The Weekly covers RFK Jr.'s Senate hearing, Sage's rejection of Biogen, and developments in the obesity space. Thank you for tuning in to Pharma and Biotech Daily.…
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1 Biotech Buzz: Updates on Lilly, Novo Nordisk, and FDA Changes 0:44
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Lilly has stopped a mid-stage study on relaxin for chronic kidney disease due to a lack of foreseeable clinical benefit, following the drug's failure in a related heart failure study. Meanwhile, Novo Nordisk's Ozempic has received FDA approval for kidney disease, expanding its use beyond diabetes and weight loss. The FDA may see changes under RFK Jr. and Makary, with concerns raised about Kennedy's vaccine-related views. BioAge has dropped an obesity asset after going public, I-Mab and Zentalis are cutting staff, and Novavax is seeking silver linings two years into a reset. Stay tuned for more updates in the biotech industry.…
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1 Pharma and Biotech Daily: Neurocrine's New Depression Drug, Novavax CEO Update, and More Industry News 0:59
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Neurocrine has secured sole rights to a potentially first-in-class depression drug called Osavampator from Takeda. Little information has been released about the drug since its promising phase II performance last spring. Meanwhile, Novavax CEO John Jacobs discusses the company's progress after layoffs, pipeline reorganizations, FDA delays, and clinical holds. Additionally, Versant Ventures has launched a new obesity startup called Helicore with a focus on improving weight loss quality. Atai has reported positive data for psychedelic therapy in alcohol use disorder, following FDA approval of J&J's esketamine nasal spray for treatment-resistant depression. Other news includes AstraZeneca and Daiichi Sankyo expanding their ADC collaboration, Metsera seeking a $289 million IPO, Pfizer receiving a breather from Starboard's assault, and more updates in the biotech industry.…
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1 Pioneering Progress in Pharma and Biotech: A Deep Dive into Innovations and Challenges 1:21
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sage has rejected Biogen's unsolicited buyout offer and will seek strategic alternatives. Biogen and Eisai have received approval for a monthly maintenance regimen for Alzheimer's drug Leqembi. Veru's drug has shown promise in sparing lean mass in overweight adults on Wegovy. The Duchenne muscular dystrophy space is on the verge of a pivotal era with several companies developing investigational therapies. Akero has rebounded in a mid-stage trial, Daiichi Sankyo is optimistic for 2025, and Allakos is cutting its workforce. The text discusses the advancements in the Duchenne Muscular Dystrophy (DMD) space as it enters a pivotal era, with companies such as Capricor Therapeutics, Wave Life Sciences, and RegenxBio working on investigational therapies to address unmet needs. It also mentions Daiichi Sankyo's recent success with the approval of Astrazeneca-partnered Dato-DXD. Additionally, new treatments are in development for Achondroplasia to challenge Biomarin's Voxzogo. Novo's obesity drug shows promising results, Merck's Keytruda combo fails in a Phase III trial for GI cancer, and Tris Pharma wins late-stage for a non-opioid painkiller. The text also invites feedback from readers on topics they would like to see covered in the future.…
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