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.

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.

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.

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

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.

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.