Pharma and BioTech Daily – Details, episodes & analysis

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 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. ## 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.

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.

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.

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.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.