Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The FDA is planning to fully integrate AI into their decision-making process by June 30, with individual centers starting the rollout immediately. Sanofi has cut off its antibody partner, leading to an 80% reduction in headcount at IgM Biosciences. The FDA has faced delays, including missing review dates for GSK's Nucala. President Trump is expected to unveil a drug pricing plan on Monday that has been criticized by big pharma and patient groups. Lotte Biologics offers end-to-end services for ADC manufacturing in Syracuse, NY. Rallybio, Insitro, Shape, and Vor have all downsized their workforces.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda's $30 billion investment in the U.S. is making headlines, along with their opposition to Trump's proposal on drug prices. The FDA's appointment of Vinay Prasad is stirring up mixed reactions within the industry. On another note, Lilly's legal victory against compounders, Novavax's growing sales, and Gilead's significant investment in U.S. manufacturing are all key developments. The FDA vaccine advisors are gearing up for a meeting to discuss COVID-19 updates, while Vor Bio is seeking an exit due to funding challenges. Biotech stocks took a hit following Prasad's appointment to lead CBER, highlighting the industry's current challenges including vaccine hesitancy and job market struggles.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novo Nordisk predicts a brighter future for Wegovy with the end of the semaglutide shortage, but analysts remain skeptical as Eli Lilly's Zepbound gains ground in sales. The new HHS vaccine requirement has raised questions about its true intentions, with leading vaccine physician Paul Offit criticizing the lack of clarity. Meanwhile, pharmaceutical imports from Ireland are on the rise, biotech stocks fell after Vinay Prasad was named to succeed Marks at CBER, and Lotte Biologics' ADC facility in Syracuse offers end-to-end services for antibody manufacturing. CRISPR's Casgevy is gaining traction with more gene therapy proof of concept expected in 2025, impacting M&A and IPOs in the biotech industry. Summit Pharmaceuticals is nearing the first global phase III data for Keytruda, set to lose exclusivity in 2028 and potentially face competition from biosimilars. A report suggests that low-price drug nations are benefiting from US innovation, undervaluing innovative medicines by 90%. VC financing in biopharma declined by 20% in Q1, but megarounds kept the median deal size high. M&A and IPOs faced challenges due to policy issues, leading to an increase in licensing deals. Novo vows to improve market access for Wegovy, while Trump orders FDA to ease US plant expansion and increase inspections of foreign facilities. BMS pledges a $40 billion investment in the US, Novartis makes M&A moves, and Lilly remains unfazed by CVS's decision to side with Novo in the obesity market battle. Some drugmakers are stockpiling products in the US amid Trump's trade war. NGM terminates half of its staff as its lead asset moves through a registrational study. Job opportunities in clinical quality assurance audit, RBQM central statistical monitoring, and field medical capabilities are available.

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.