Episodes
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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.Two companies, Beam Therapeutics and Verve Therapeutics, have developed lead candidates using a safer alternative to conventional CRISPR called base editing. Clinical results have been promising. FDA insiders are calling on FDA Commissioner Marty Makary to fight against agency politicization. The Trump administration, including HHS Secretary Robert F. Kennedy Jr., is accused of distorting and denying scientific truths and potentially censoring information.FDA action alerts include expansion bids for drugs by GSK and Merck. A new AI-powered solution called Generative AIPTP helps life sciences firms streamline clinical workflows. The FDA is rehiring travel staff as lapses begin to show.RFK Jr. is driving a wedge into vaccine conversations. WHO may add obesity drugs for adults to the essential medicines list. Various companies like Merck, GSK, and Roche present key data at AACR 2025.HHS will require placebo-controlled trials for all new vaccines in a radical departure from past practices. Tariffs dominate Q1 earnings, AACR excites the cancer space, CEO pay gaps are discussed, and more news and events are highlighted.
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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. Amgen, along with other big pharma companies, is advocating for a "pro-growth tax policy" over tariffs to boost domestic pharmaceutical manufacturing. They are urging the Trump administration to consider tax policy as a better alternative. A report suggests that low-price drug nations are benefiting from US innovation, FDA is rehiring travel staff, and there are concerns about censorship of scientific truths by RFK Jr. Trilink Biotechnologies has introduced custom sets of mRNA for screening studies. Updates include potential additions of obesity drugs to essential medicines list, company buyouts, layoffs in the industry, and upcoming events and job opportunities in the biotech sector.
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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's revenue jumped by 45% in the latest quarter, driven by the success of their drugs Zepbound and Mounjaro. Moderna missed revenue expectations for the first quarter but plans to cut $1.5 billion in costs. Biogen executives are dealing with tariffs, but believe the impact will be minimal. The Department of Health and Human Services announced a new policy requiring placebo-controlled trials for all new vaccines, which has been met with criticism from experts. Trilink Biotechnologies has introduced custom sets of mRNA for screening studies. In other news, CVS has chosen Novo's side in the obesity market battle, RFK Jr. is sparking controversy in vaccine discussions, and J&J has entered the myasthenia gravis market. Additionally, AstraZeneca faced a setback with their drug Truqap in a phase III prostate cancer study.
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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 recently acquired Regulus for $1.7 billion, signaling a trend of increased M&A activity in the pharmaceutical industry. Many companies have hinted at upcoming deals during recent earnings calls, which is seen as a positive sign for the biopharma ecosystem amidst challenges like tariffs and potential drug pricing pressures. GSK remains optimistic about M&A opportunities despite the threat of tariffs, with CEO Emma Walmsley emphasizing a cautious and disciplined approach to dealmaking. Trilink Biotechnologies has introduced custom sets of mRNA for screening studies, offering flexibility and scalability for research needs. The AACR 2025 conference featured promising data from Marengo and Briacell, while Pfizer CEO Albert Bourla has been lobbying against pharmaceutical industry tariffs proposed by President Trump. Overall, the industry is seeing a mix of challenges and opportunities, with companies navigating trade tensions and economic uncertainties while also pursuing strategic growth through acquisitions and innovative research initiatives.Pharmaceutical companies are navigating political uncertainties, particularly in relation to tariffs and dealmaking with China. Major companies are investing billions in US manufacturing to avoid tariffs threatened by President Trump. Despite lobbying efforts, Trump has expressed national security concerns regarding the pharmaceutical industry. CEO-to-employee pay gaps in the industry remain significant. Novartis, GSK, and AstraZeneca are facing challenges and making strategic shifts in response to political and market conditions. Tariff uncertainty is impacting Q1 earnings, with companies like Merck taking significant financial hits. Despite these challenges, the industry remains active with mergers and acquisitions. Upcoming events and job opportunities in the biopharma sector are highlighted.
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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. AstraZeneca has decided to abandon its neuroscience research and focus on weight loss and immunology, following recent discontinuations in Alzheimer's and migraine research. FDA experts are urging Commissioner Makary to resist politicization of the agency. Novartis CEO dismisses tariffs but warns against Trump's pricing controls. Pfizer announces $1.7 billion in cost savings, including a revamp of its R&D organization. Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Other news includes Steminent showcasing therapy for spinocerebellar ataxia, Regeneron's shares tumbling, and ABEONA receiving FDA approval for a gene therapy for a rare skin disease. In summary, AstraZeneca shifts focus, FDA concerns arise, Novartis CEO speaks out, Pfizer announces cost savings, Trilink Biotechnologies introduces new product, Steminent showcases therapy, Regeneron's shares tumble, and ABEONA receives FDA approval.
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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.Akeso's drug, Ivonescimab, has received approval in China as a competitor to Merck's Keytruda. However, its prospects in the US, where Summit owns the rights, are uncertain. Merck KGaA is acquiring SpringWorks for $3.9 billion to enhance its rare disease and oncology pipelines. Keytruda has shown promising results in reducing negative events in head and neck cancer patients. The cell and gene therapy sector faces challenges post-Marks FDA exit, including tariffs and workforce cuts.Transitioning to the next news, Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Steminent Biotherapeutics is set to showcase a novel therapy for spinocerebellar ataxia. The cell and gene therapy sector is facing a critical period after the exit of FDA director Peter Marks, with threats such as tariffs and workforce cuts. Experts are uncertain about the future but are hopeful that Marks' legacy will continue under new FDA commissioner Marty Makary.Moving on to the upcoming American Association for Cancer Research meeting, which will feature presentations from companies like Merck and Boehringer Ingelheim that could impact cancer treatment. The industry in the U.S. is experiencing significant changes under the Trump administration, while conditions of regulatory and economic turmoil are more common in non-western markets. Makary's first interviews as FDA commissioner have raised questions about the accuracy of his statements.Lastly, the biopharma industry is also dealing with setbacks such as disappointing trial results and safety concerns. Overall, the sector is facing challenges but remains hopeful for the future under new leadership.
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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.AbbVie, a pharmaceutical company, has criticized President Trump's drug pricing proposal despite reporting strong earnings this quarter. The company is facing challenges with declining sales of its drug Humira and a struggling aesthetics business. Meanwhile, Gilead is moving forward with the launch of its HIV drug despite macro pressures in the industry. FDA Commissioner Marty Makary's recent statements have been fact-checked, with some contradictions emerging.In other news, SpringWorks is potentially being bought out by Merck KGaA for $3.5 billion. Wacker Biotech is offering services for advanced therapies. Stay tuned for more updates on these developments in the pharmaceutical and biotech sectors.
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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.The first quarter earnings calls of major pharmaceutical companies were dominated by uncertainty surrounding President Trump's tariffs. Merck took a $200 million hit due to the tariffs, while Roche believes it is well-positioned to weather the impact. Despite challenges, companies are preparing for potential impacts of the tariffs on their businesses. This uncertainty is also affecting M&A activity in the pharmaceutical industry. Wacker Biotech is positioning itself as a partner for advanced therapies, offering services for process development and production of PDNA and mRNA therapies. Novavax asserts that its COVID-19 shot is "approvable", Vanda criticizes the FDA for delays, and there are updates on investments in innovative therapies. The industry is also reshaping the women's health landscape with economic challenges and strategic investments. Overall, companies are navigating through challenges while striving to thrive in a changing biotech landscape.
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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.Lilly is currently involved in a legal battle with compounders over knockoff versions of tirzepatide, marketed as Zepbound for weight loss. The FDA has prohibited compounders from producing these knockoffs after confirming the end of the tirzepatide shortage in December 2024. On the other hand, BMS is facing disappointment with Cobenfy's late-stage failure in treating schizophrenia, marking their second high-profile setback in recent weeks. RFK is contemplating removing COVID-19 from the CDC's vaccine guidelines for children to align with other countries and the WHO. Biotech investors are navigating a turbulent period due to new tariffs and economic uncertainty, causing additional upheaval in an already fragile market. Trump is looking to reinstate international drug pricing policies, while Swiss ADC Biotech is opting for the SPAC route to Nasdaq.Summit's bispecific has outperformed another cancer medication, putting pressure on Keytruda's dominance. In the midst of this biotech downturn, Wacker Biotech is offering advanced therapy process development and production services. Moving on to the next news, executives in the pharmaceutical industry often receive substantial golden parachutes upon leaving a company. Pfizer is defending its cardiac blockbuster drug against competition from Alnylam and BridgeBio. The biotech sector was showing signs of a rebound until new tariffs and economic uncertainty introduced further instability.Lilly is pursuing legal action against compounders for producing counterfeit drugs, while Roche and Regeneron are committing billions to US manufacturing amidst tariff challenges. The industry is undergoing significant changes under the current administration, with opportunities to learn from global markets. Challenges such as investor pullback and market volatility are impacting the biotech sector.Janssen's departure from Galapagos and the promising future of all-American biotech companies are also discussed. Stay tuned for more updates on upcoming events and job opportunities in the field.
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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.Roche and Regeneron are both investing heavily in US manufacturing, with Roche committing $50 billion and Regeneron signing a $3 billion deal with Fujifilm. This move comes as Trump's tariffs threaten the industry. Meanwhile, Pfizer, Alnylam, and BridgeBio are competing in the market for ATTR-CM treatment, with Alnylam and BridgeBio vying for patients switching from Pfizer's tafamidis drug and all three companies seeking new patients.Novo Nordisk has filed for FDA approval of an oral weight loss pill, AstraZeneca and Daiichi Sankyo are pushing their drug Enhertu for frontline breast cancer treatment, and Gilead's Trodelvy in combination with Keytruda has shown promise in slowing disease progression in triple-negative breast cancer. Wacker Biotech is offering services for advanced therapies, while Tempest has recently laid off 80% of its workforce.The industry is facing regulatory challenges and economic uncertainty, with Trump's tariffs potentially impacting pharma companies. Lilly has promised to manufacture a weight-loss pill in the US following a phase III win, and Makary discusses rare disease approvals and public distrust in a new interview. Biotech's future may be more focused on American companies according to PitchBook.
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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. In a recent interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary discussed a potential new mechanism-driven pathway for expedited rare disease approvals, as well as the possibility of certain environmental factors contributing to autism. Despite Makary's announcement of a directive to limit industry participation in the FDA's advisory committees, industry involvement is actually required by a 1997 law, and banning industry representatives would not have a significant impact. Additionally, the FDA recently approved Sanofi/Regeneron's Dupixent for chronic hives after initially rejecting it, and Lilly has promised to manufacture a weight-loss pill in the US following a Phase III win. The newsletter also includes other news stories, opinions, and upcoming events in the biopharmaceutical industry.
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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.##New vaccine shows promising results in clinical trialsA new vaccine for a common virus has shown promising results in clinical trials, with a high efficacy rate and minimal side effects. This development could potentially revolutionize the way we prevent and treat this virus in the future.##FDA approves groundbreaking gene therapy for rare genetic disorderThe FDA has approved a groundbreaking gene therapy for a rare genetic disorder, marking a significant milestone in the field of genetic medicine. This therapy has the potential to transform the lives of patients suffering from this debilitating condition.##Big pharma company announces major mergerA major pharmaceutical company has announced a merger with another big player in the industry, creating a powerhouse in the global pharmaceutical market. This merger is expected to have far-reaching implications for the industry as a whole.##Biotech startup secures record-breaking funding roundA biotech startup has secured a record-breaking funding round, signaling strong investor confidence in their innovative approach to drug development. This funding will allow the startup to advance their research and bring potentially life-saving treatments to market.##Researchers discover new mechanism of action for cancer drugResearchers have discovered a new mechanism of action for a commonly used cancer drug, shedding light on how it effectively targets cancer cells. This discovery could lead to the development of more targeted and effective cancer treatments in the future.##FDA issues warning about potential side effects of popular arthritis medicationThe FDA has issued a warning about potential serious side effects associated with a popular arthritis medication, urging patients to consult their healthcare providers before starting or continuing treatment. This warning highlights the importance of monitoring and reporting adverse reactions to medications.##Biopharmaceutical company announces breakthrough in Alzheimer's researchA biopharmaceutical company has announced a major breakthrough in Alzheimer's research, identifying a promising new drug candidate that could potentially slow or even reverse the progression of the disease. This development offers hope for millions of patients and their families affected by Alzheimer's.##Pharma giant partners with leading research institute to accelerate drug discoveryA pharmaceutical giant has partnered with a leading research institute to accelerate drug discovery efforts and bring innovative therapies to market faster. This collaboration aims to leverage the strengths of both organizations to address unmet medical needs and improve patient outcomes.##Health authorities approve new treatment for rare autoimmune diseaseHealth authorities have approved a new treatment for a rare autoimmune disease, providing much-needed hope for patients who have struggled to find effective therapies. This approval represents a significant milestone in the field of autoimmune medicine.##Biotech company receives grant to develop novel antibioticA biotech company has received a grant to develop a novel antibiotic targeting drug-resistant bacteria, addressing a critical need in the fight against antibiotic resistance. This funding will support the company's research efforts and help bring this potentially life-saving treatment to market.##Innovative technology platform revolutionizes drug deliveryAn innovative technology platform has revolutionized drug delivery, enabling more precise targeting of drugs to specific cells or tissues in the body. This technology has the potential to improve treatment outcomes and reduce side effects for patients across various therapeutic areas.#End of podcast episode
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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.Eli Lilly's shares surged 11% after their obesity pill, orforglipron, showed "injectable-like efficacy" in a phase III diabetes trial. The drug achieved significant reductions in body weight and improvements in glucose control, making it the first small-molecule GLP-1 drug to ace a late-stage study for type 2 diabetes. Kennedy's search for a link between vaccines and autism is criticized as misguided, and Trump plans a $40 billion budget cut for HHS. Biotech companies are urged to focus on all-American manufacturing due to tariffs, and experts discuss the importance of product validation in cell and gene therapies. RFK Jr. advocates for changes to vaccine injury surveillance, while HHS withdraws funding for GeoVax's next-gen COVID-19 vaccines. Sanofi invests over $1.8 billion in AI-developed bispecifics, and Q1 Biopharma announces layoffs in California and Massachusetts. Former FDA officials warn of unseen changes within the agency, and J&J's tariff decisions set the tone for Q1 earnings reports. Top-paid pharma CEOs are revealed for 2024.
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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 has signaled support for removing the IRA's 'pill penalty', with analysts cautiously optimistic about the executive order. Tariffs are in focus as Q1 earnings get underway, with EU and US pharmas making demands of the European Commission. Former FDA officials warn of potential implications of workforce cuts at the FDA. J&J sets the tariff tone as Q1 earnings begin to roll in. Experts offer advice on optimizing process development and validation steps for cell and gene therapies. In other news, bluebird's second suitor, Ayrmid, fails to make an offer, and the top 6 highest-paid pharma CEOs in 2024 are revealed.The top 6 highest paid pharma CEOs in 2024 have been revealed, with Johnson & Johnson's Joaquin Duato no longer holding the top spot. Duato has urged for a tax fix rather than tariffs to drive US pharma manufacturing. Viking Therapeutics saw a share rally after rival Pfizer discontinued an obesity candidate. Johnson & Johnson's Q1 earnings beat analyst estimates, thanks to Tremfya and Carvykti. Novartis has pledged a $23 billion boost to US operations amid tariff threats. Trump has signaled support for removing IRA's pill penalty and opened a national security probe on pharma imports. The industry is facing uncertainty due to ongoing tariff drama. Trilink's grna for gene editing has been successful, offering high-purity custom guide RNAs for research purposes. Trump's tariff pause sparked a late-day rally for pharma stocks. Some companies, like Glycomine, Merck, and Boehringer Ingelheim, have received significant funding or made deals in the biopharma sector.Senior Editor Annalee Armstrong encourages readers to suggest topics for future coverage in the biopharma industry.
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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.President Trump has opened a national security probe on pharmaceutical imports, potentially leading to tariffs on these products. Johnson & Johnson reported strong earnings in Q1 thanks to certain drugs, while a phase III trial for BMS' Camzyos did not show new benefits. J&J CEO Joaquin Duato called for tax changes instead of tariffs to encourage drug manufacturing in the U.S. Merck is exploring oral peptide delivery through a new deal, while Boehringer Ingelheim is expanding its portfolio in the inflammation and immunology space. In response to Trump's tariff threats, J&J and other pharma companies are investing in U.S. manufacturing. Thank you for listening to Pharma and Biotech daily.
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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.Pfizer has dropped its lead obesity molecule, danuglipron, due to safety concerns regarding liver issues, leaving the company with only one molecule in its obesity pipeline. This decision has raised questions about the future direction of Pfizer's obesity research. Additionally, there are fears about the impact of recent firings at the Department of Health and Human Services on the FDA, with concerns about delays in drug approvals and increased political influence on regulatory decisions.In other news, Verve's base editor showed promise in lowering bad cholesterol levels in a phase Ib trial, and there are ongoing legal battles between Vanda and the FDA over off-label use of a drug for jet lag. Overall, the biotech industry is facing challenges and uncertainties in light of recent developments.The FDA is facing an uncertain future following a major overhaul by Kennedy, which included staff cuts that could threaten user fees, nearly half of the FDA's budget. Drug review delays and increased executive oversight are expected, with fears mounting about the agency's future direction. AI is enabling the development of smart antibodies that can more precisely target cancer cells while sparing healthy tissues.Upcoming FDA actions include a cell-based gene therapy for a rare skin disease and product expansions for Regeneron and Sanofi. Experts are concerned that FDA layoffs could trigger a mechanism that may set the industry back 35 years. Other news includes the FDA replacing some animal testing with AI and human 'organoid' lab models, changing attitudes towards the MMR vaccine, recent approvals in colorectal cancer, and more.Readers are encouraged to provide feedback on what topics they would like to see covered next.
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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.Lawmakers are focusing on boosting the US biotech industry while keeping China's growth in check. Novartis plans to invest $23 billion in US operations, potentially creating up to 1,000 new jobs. The FDA is exploring the use of AI and human 'organoid' lab models to replace some animal testing. The current tariffs and layoffs in the biopharma industry under the Trump administration have created uncertainty. Experts are advising companies to optimize process development for gene therapy products. Biopharma professionals are engaging in discussions on how nonprofit organizations can drive healthcare innovation amidst significant industry layoffs, such as Opthea cutting 65% of staff and Pfizer cutting 56%. The recent tariff pause by Trump has led to a late-day rally for pharma stocks. upcoming events include webinars on AI, regulation, and drug development laws, as well as strategies for surviving in the biotech downturn. Biotech leaders are calling on Senator Cassidy to address FDA cuts that could potentially set the US back 35 years.
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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.Pharma stocks had a turbulent day after Trump's tariff pause, with some stocks making a late-day recovery. However, there are concerns about potential FDA budget cuts that could severely impact drug access in the US. Biotech leaders are calling on Senator Cassidy to take action in response to these cuts, which have already caused delays and uncertainty in the regulatory process. Experts are warning that jeopardizing the FDA user fees program could have dire consequences.In other news, nonprofit organizations are playing a key role in driving innovation in healthcare. Tempest is currently seeking funding for a late-stage liver cancer asset, while Amgen's Uplizna has shown promising results in treating myasthenia gravis.Upcoming events include webinars on AI and regulation in drug development, as well as strategies for navigating the biotech downturn. On a less positive note, several biopharma companies have announced layoffs, including Vincerx and Reckitt Benckiser.Overall, the industry is facing challenges but also opportunities for growth and advancement.
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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. President Trump's announcement of 'major' pharmaceutical tariffs has caused market turmoil and a decrease in industry value. Analysts predict increased costs for medicines and potential negative effects on patient drug access. Pharmaceutical companies are preparing for potential financial impacts as they brace for the implications of the upcoming tariffs on their operations and bottom line.The pharmaceutical market is witnessing a significant decline in value due to President Trump's tariffs, with billions in market cap being shed. Analysts forecast increased costs for medicines as a result of the tariffs, posing challenges for the traditionally recession-resistant industry. Intense competition between drug rivals is evident, with companies like Eli Lilly experiencing significant drops in value. Wacker Biotech is offering their services as a partner for advanced therapies, amidst warnings about China overtaking the US in biotech and FDA job cuts under Trump's administration. Various developments in the biopharmaceutical industry are also shaping the landscape. Job openings in the sector are highlighted, urging readers to subscribe to the Biospace newsletter for updates on news and trends.
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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.The pharmaceutical industry, traditionally seen as recession-resistant, may face challenges due to Trump's tariffs and the dominance of GLP-1s. Lexeo is moving forward with a gene therapy for Friedreich's ataxia after promising phase I/II data, while Rallybio is pivoting to a new antibody for rare autoimmune disorders. HHS Secretary Robert F. Kennedy, Jr. will not be speaking to the Senate health committee this week as scheduled. In other news, Merida is entering the autoimmune and allergy arena with a $121 million series A funding. Lilly is suing an Indianapolis spa for selling knockoff versions of its migraine drug Zepbound, and biotech shares are affected by the departure of FDA's Marks. Cardiovascular disease is back in the spotlight.
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