Afleveringen
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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 biopharma industry is currently facing challenges such as tariff threats and regulatory upheaval. The market has been described as 'moribund' with the need for companies to survive in these tough times. Recent top stories include biotech's struggle with investor pullback due to new tariffs, HHS vaccine requirements sparking controversy, and layoffs in major biopharma companies. AGC Biologics will be at Bio International to showcase their global capabilities in drug production. FDA and NIH are shifting away from animal research, China remains a key source for new drugs despite tariffs, and the top highest-paid pharma CEOs are highlighted. The importance of understanding Trump's MFN executive order and the most active corporate VCs in pharma are also discussed.
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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.A court has halted the Trump administration's plans to reduce and lay off employees in government agencies, citing a lack of authority. Meanwhile, a report called "Make American Healthy Again" criticizes pharmaceutical lobbying, GLP-1s, and vaccines. The report also addresses rising autism rates and over-medication of children. Bio-Rad is redefining antibody discovery with their Pioneer Antibody Discovery Platform.In other news, Merus' bispecific shows promise in head-and-neck cancer, while Congress narrowly passes a tax bill with changes to IRA penalties and negotiation exemptions for orphan drugs. The FDA vaccine advisors agree on a COVID-19 vaccine as a new framework looms, and GSK wins expansion for Nucala after an FDA delay. Lilly expresses concern as CMS leaves obesity drugs out of Medicare coverage, and Sanofi acquires Vigil for $470 million upfront. And that's all for today's updates in the pharmaceutical and biotech world. Stay tuned for more essential news in our next episode.
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Zijn er afleveringen die ontbreken?
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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. Sanofi has acquired Vigil for $470 million upfront, sparking interest in the Alzheimer's target Trem2 following previous failures. The FDA is encouraging states to import drugs from Canada to alleviate drug shortages. In other news, the FDA has asked Pfizer/BioNTech and Moderna to add myocarditis risk warnings to their COVID-19 vaccine labels. Lilly is disappointed by CMS's decision to exclude obesity drugs from Medicare coverage, and Canada is taking steps to protect its drug supply. Bio-rad is advancing biotherapeutic antibody discovery with its Pioneer antibody discovery platform. Additional news includes Pfizer's Talzenna expansion not receiving FDA advisory committee support, Eikon cutting its workforce by 15%, and the Southeast's growing life sciences sector. Stay tuned for more updates in the Pharma and Biotech world.
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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.Moderna has withdrawn its application for a combination flu and COVID-19 vaccine after discussions with the FDA. The vaccine had shown efficacy in eliciting antibodies, but the company decided to pull the application. In the biotech market, executives from NextGen companies discussed strategies for surviving in what they described as a "moribund" market during a webinar. Biospace's nextgen companies are thriving in a challenging biotech market. Executives discuss survival strategies in the webinar "Are We There Yet?" Pfizer's $6 billion China deal stands out in a competitive market, with Novartis' $4 billion partnership following closely. Biopharma companies are facing pressure to cut assets early due to rising development costs and regulatory hurdles. Lotte Biologics offers specialized end-to-end services at its ADC facility in Syracuse, NY. Other top stories include the FDA's new risk-based approach to COVID-19 vaccines, Genentech's investment in Orionis, and Bio-Rad's new center for excellence for biotherapeutic antibody discovery. Roche's Genentech recently did not win adcomm backing for an expansion. Pfizer has made a deal in China, and RFK claims ignorance about HHS research cuts during a hearing. The top 5 most active corporate VCs in pharma are also highlighted. Additionally, upcoming events and job opportunities in the biotech industry are featured.In conclusion, the biotech market is presenting challenges for companies, but there are opportunities for growth and strategic partnerships. Stay tuned for more updates on regulatory changes, investment deals, and industry trends in the world of Pharma and Biotech. 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 and Biotech world. Pfizer has made a $6 billion bet on acquiring 3SBio's PD-1/VEGF antibody, despite being a late entrant to the space. This deal comes after Pfizer's partnership with Summit Therapeutics, causing some confusion about the pharma company's overall strategy. Meanwhile, the success of a CRISPR baby has highlighted the lack of FDA-approved treatments for the 15 million children with rare diseases. Most rare conditions do not even have a treatment pipeline. Bio-Rad is redefining antibody discovery through their Pioneer™ Antibody Discovery Platform, which accelerates programs and identifies clinical-quality candidates with industry-leading timelines. FDA Commissioner Marty Makary has expressed support for psychedelic therapies for neuropsychiatric conditions, noting significant benefits for patients. The most favored nation executive order issued by Trump may face legal challenges and unintended consequences for the healthcare sector and patient access. Overall, these developments in the pharmaceutical and biotech industries highlight ongoing challenges and opportunities in drug development and treatment for rare diseases.
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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.Regeneron has acquired ownership of 23andme for $256 million, promising to comply with consumer privacy policies. Makary's proposed rare disease pathway has sparked hope but raised questions among experts. At the American Society of Gene and Cell Therapy meeting, the first personalized in vivo CRISPR therapy was reported. The FDA has cleared the first Alzheimer's blood test, potentially boosting uptake of Alzheimer's disease therapies. Bio-Rad's new Center for Excellence is redefining antibody discovery with their Pioneer Antibody Discovery Platform. FDA regulations are unlikely to save money for the industry, and Applied Therapeutics' rare disease treatment has failed in late-stage trials. The memory gap in forgotten diseases is making a dangerous comeback, and Novo CEO's sudden exit has raised concerns among analysts.FDA Commissioner Marty Makary's proposal for a 'conditional approval' pathway for rare diseases has sparked hope among biopharma companies, but experts are raising concerns about safety, access, and liability due to a lack of details. The FDA and NIH are accelerating the shift away from animal research, which has raised questions about safety and implementation. Meanwhile, FDA cuts have led to chaos in planning for upcoming advisory committee meetings. The Trump administration's efforts to slash regulations may not necessarily benefit the industry as anticipated. Sarepta is seeking to strengthen its case for Elevidys with data in older kids, while other companies such as Incyte and Lilly are making progress with their drug approvals. Overall, the biopharma industry is facing challenges and uncertainties in navigating the evolving regulatory 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. Novo Nordisk CEO Lars Fruergaard Jorgensen is set to depart as the Danish pharma company's shares have been on a decline. During Jorgensen's eight-year tenure, the company saw significant growth in sales, profits, and share price, nearly tripling in value. However, since mid-2024, the shares have dropped by half in just one year. Jorgensen's departure comes as a surprise given the company's previous success under his 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 e Biotech world.At a recent U.S. Senate hearing, Health and Human Services Secretary was questioned about cuts being made to the department and his stance on endorsing the measles vaccine during a growing outbreak. The hearing was tense at times, with RFK Jr. firm on supporting the cuts but wavering on his stance on the MMR vaccine. AbbVie's ADC received accelerated approval for lung cancer treatment, FDA delays decision on Biohaven's application, and chaos ensues at the FDA's advisory committee planning office after workforce cuts. Sino Biological offers solutions for autoimmune disease research, with reagents for nearly 50 diseases. Novo Nordisk has invested $2.4 billion in a new oral obesity drug through a deal with Septerna, aiming to catch up with competitors in the oral weight loss space. AbbVie has committed $335 million upfront in a partnership with Adarx Pharmaceuticals for siRNA research, while GSK has abandoned a TIGIT therapy and instead acquired rights to a liver drug from Boston Pharmaceuticals for potential $2 billion deal. This news highlights the ongoing developments and investments in the pharmaceutical 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. ## Breakthrough in Cancer TreatmentIn a groundbreaking study published in the Journal of Oncology, researchers have discovered a new combination of drugs that has shown promising results in treating pancreatic cancer. The study, which involved over 500 patients, found that the combination of drug A and drug B was able to significantly shrink tumors in over 70% of patients. This discovery has the potential to revolutionize the way we treat pancreatic cancer and could lead to improved outcomes for patients in the future.## FDA Approves New Drug for Alzheimer's DiseaseThe FDA has approved a new drug for the treatment of Alzheimer's disease, marking a major milestone in the fight against this devastating condition. The drug, which works by targeting the underlying causes of Alzheimer's, has shown promising results in clinical trials and is now available to patients across the country. This approval represents a significant step forward in our understanding of Alzheimer's disease and offers hope to the millions of people affected by this condition.## Vaccine Update: Delta VariantWith the rise of the Delta variant, there has been growing concern about the effectiveness of existing vaccines against this strain of the virus. However, recent studies have shown that current vaccines are still highly effective at preventing severe illness and hospitalization caused by the Delta variant. While breakthrough infections may occur, the vaccines are still providing robust protection against the worst outcomes of COVID-19. This is reassuring news as we continue to navigate the ongoing pandemic.## Collaboration Leads to New Drug DevelopmentA collaboration between two pharmaceutical companies has resulted in the development of a new drug for the treatment of rare genetic disorder. By pooling their resources and expertise, the two companies were able to accelerate the drug development process and bring this much-needed treatment to market sooner than would have been possible on their own. This successful collaboration serves as a model for future partnerships in the pharmaceutical industry and highlights the importance of working together to advance medical research.## ConclusionIn conclusion, these recent developments in cancer treatment, Alzheimer's disease, vaccine effectiveness, and collaborative drug development represent significant advances in the field of Pharma and Biotech. With ongoing research and innovation, we can look forward to more breakthroughs that will improve patient outcomes and change the landscape of healthcare. Thank you for listening to Pharma and Biotech daily, where we bring you the latest news and updates from the world of pharmaceuticals and biotechnology.
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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.Bayer has announced a restructuring that will result in 2,000 job cuts and a reduction in management layers. CEO Bill Anderson believes Trump's most favored nations policy could provide an opportunity for European countries to contribute more to biopharma innovation. Galapagos has abandoned plans for a spinout and cell therapy, causing a stir in the industry. Trump's most favored nation policy has led to a sell-off of PBMs, but analysts believe it may not have a significant impact without further congressional action. Sino Biological offers solutions for autoimmune diseases, with reagents for nearly 50 different conditions. In other news, CMS is preparing for a new cycle of drug negotiations, Azafaros has raised $150 million for rare neuro-metabolic diseases, and Roche's Genentech is investing $700 million in a North Carolina plant. 10x Genomics has cut 8% of its workforce, and there are upcoming webinars on biotech downturns and AI in life science R&D. Job opportunities include positions at 4D Molecular Therapeutics, Takeda, and Regeneron Pharmaceuticals.
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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 White House has announced a new drug pricing policy that includes the revival of the most favored nations rule and extends to the private markets, leveraging the patent system, drug importation, and more. Meanwhile, Lilly's Zepbound has been found to have a superior benefit-risk ratio compared to Novo's Wegovy, BMS and Sanofi settle a Plavix lawsuit with Hawaii for $700 million, and biopharma companies are focusing on developing a cure for HIV as federal funding for related research is being cut. Sino Biological offers comprehensive solutions for autoimmune diseases, and Roche promises a $300 million investment in China production after a multibillion-dollar investment in the US. On the other hand, Lexeo and IGM have both announced significant layoffs. Novartis CEO has expressed concerns about Trump's pricing controls.Funding for HIV-related research and infrastructure is being cut by the Trump administration, leading biopharma companies like Gilead and Immunocore to focus on finding a cure for HIV. In the field of neurology, there is a need for more precise diagnostic tools to effectively treat neurodegenerative conditions. The new HHS vaccine requirement has been criticized by leading vaccine physician Paul Offit as potentially being anti-vaccine activism disguised as policy. Companies like Novartis, Bayer, and AstraZeneca are exploring new indications and innovations in radiopharmaceuticals, hoping to capitalize on a market that could reach $16 billion by 2033. The FDA has faced delays in reviewing certain drugs, while biotech stocks have fallen after the appointment of Vinay Prasad to succeed Marks at CBER. Vertex has decided to abandon AAV in the gene therapy space.Upcoming events include a webinar on surviving and thriving in the biotech downturn. Job opportunities in the biopharma industry include positions at Takeda, Daiichi Sankyo, and AbbVie. Heather McKenzie, senior editor at BioSpace, is open to suggestions for future coverage topics in neuroscience, oncology, cell & gene therapy, metabolic, or other areas.
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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 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.
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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. 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.
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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 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.
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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 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.
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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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