Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Donald Trump has issued an executive order to expedite the timeline for building new facilities in the US while increasing inspections on foreign plants. Despite a drop in venture capital fundraising in the first quarter of the year, large investments are still being made in the pharmaceutical industry. Companies like BMS are investing billions in US manufacturing despite potential tariffs. Vertex has seen success with their non-opioid pain drug launch and biopharma venture capital fundraising has declined, but median deal sizes remain high. Lotte Biologics offers specialized ADC manufacturing services in Syracuse, NY. Other news includes Lilly's ALS pipeline expansion, states suing to block HHS cuts, and layoffs at PTC despite a Phase II win. Thank you for tuning in to today's episode of Pharma and Biotech daily. Let's dive into the latest updates from the industry.

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.

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.

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.

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.

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.

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.

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.

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.

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.