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 has launched a direct-to-consumer program for their drug Wegovy, offering it at a reduced price of $499 per month for uninsured or underinsured patients, less than half of the drug's list price. Meanwhile, rare disease biotechs are facing challenges as Congress has failed to renew the rare pediatric disease priority review program, creating uncertainty and concerns within the biopharma industry. Congress failed to renew the rare pediatric disease priority review program at the end of 2024, leaving rare disease biotechs in a difficult position. Companies spent $513 million on priority review vouchers in 2024. Delphia, a biotech company, launched a new precision medicine approach called Activation Lethality in May 2024. The top 10 best-selling drugs of 2024 included Merck's Keytruda and Abbvie's Humira. Pfizer is prepared to reshore manufacturing if tariff threats are realized. Other news includes BridgeBio Oncology's plan to go public, Abbvie's deal with Gubra, and GSK CEO Emma Walmsley's pay increase. Industry leaders will be discussing the future of orphan drug development and rare disease care at the upcoming World Orphan Drug Congress in 2025. Annalee Armstrong, senior editor for Biospace, invites readers to suggest topics for future coverage and provide feedback to improve their Biospace experience.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Pfizer and Eli Lilly are considering reshoring manufacturing in the U.S. in response to President Trump's tariff threats. Biohaven faces setbacks in clinical trials, while Roche gains FDA approval for a stroke drug expansion. Startup Delphia aims to use a precision medicine approach to target cancer cells. Industry leaders will discuss orphan drug development at the World Orphan Drug Congress 2025. Other news includes Beigene's label expansion, AstraZeneca and Daiichi Sankyo's success with Enhertu in stomach cancer, and Atara's restructuring.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. AbbVie has recently entered the obesity market through a deal with Gubra for Amylin, worth up to $2.2 billion. This move positions AbbVie among industry leaders like Novo Nordisk and Eli Lilly. The focus on redefining obesity as a chronic disease is gaining momentum, with recent FDA documents and The Lancet Diabetes & Endocrinology commission highlighting the importance of maintenance treatment. In immuno-oncology, experts are searching for the next breakthrough beyond Keytruda and Yervoy. Novel targets, combinations, and pre-emptive immunization are being explored as potential areas of growth. The upcoming World Orphan Drug Congress in 2025 will gather industry leaders to discuss the future of orphan drug development and rare disease care. Positive developments have been reported for Biogen and Eisai's Leqvio in Europe, AstraZeneca and Amgen's Phase III win for Tezspire, and advancements in non-opioid painkillers by Lexicon. The text also discusses the maturation of immuno-oncology, the potential of mRNA technology in rare diseases, recent FDA approvals for rare disease treatments, the evolving mindset towards treating obesity as a chronic disease, and updates on FDA-related news. Lastly, job opportunities in the biotech industry are available at AbbVie, Moderna, Arvinas Inc., and Sonothera. Share your input on topics to cover in the biopharma industry.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Lilly has entered a $1.6 billion deal in the molecular glue space, following the steps of other big pharma players like Novo Nordisk, Pfizer, and Novartis. On the other hand, the FDA, NIH, and CDC are experiencing chaos with canceled meetings and postponed discussions since Donald Trump's return as U.S. president, without a clear reason. In other news, Cassava's stock is on the rise after licensing seizure rights for simufilam, while BridgeBio Oncology is going public through a SPAC deal. Meanwhile, Vertex has decided to sever a partnership for liver gene therapies. Trilink is offering mRNA designs for reliable performance, and Eisai is planning to cut 7% of its US workforce.The role of mRNA in bridging the innovation gap in rare diseases is being discussed, highlighting the importance of industry and AI in fighting misinformation and empowering patients.Thank you for tuning in to Pharma and Biotech daily.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. The FDA's vaccine planning meeting was canceled due to disruptions caused by Robert F. Kennedy Jr. GSK's CEO Emma Walmsley received a pay increase to align with industry standards. Lilly invested $27 billion in US manufacturing after Trump's tariff threats. Regeneron scaled back approval goals for a lymphoma bispecific drug. Kallyope released disappointing data for an oral obesity candidate. Trilink offers mRNA designs for reliable performance. Congress reintroduced the EPIC Act to remove IRA's 'pill penalty'. Layoffs were announced at Lava and Ryvu, with new job opportunities in the life sciences industry available.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The Epic Act has been reintroduced in Congress to remove the IRA's 'pill penalty', with hopes for positive changes. However, budgetary constraints may make it challenging for the current administration to make significant amendments to the IRA. As money continues to flow into weight loss drugs, physicians are prioritizing efficacy and access. Emalex is moving towards FDA approval after a successful Phase III trial for Tourette Syndrome. AstraZeneca also received positive Phase III results for an oral breast cancer drug. SpringWorks Therapeutics successfully turned a Pfizer 'ghost drug' into a victory by keeping a rare disease program alive with the help of advocacy groups. This success story has led experts to believe that this method could be applied to other rare diseases as well. The company serves as a case study for how to mine biopharma's IP storeroom for rare disease drugs.Meanwhile, weight loss doctors are seeking better GLP-1 medications, but are facing challenges with high prices and supply issues. Trump is threatening big pharma with tariffs unless they reshore manufacturing. Bluebird Bio is facing financial challenges and may go private in a deal valued at $30 million. Compounders are suing the FDA over declaring a shortage of certain drugs, while the FTC is tightening merger rules despite the Trump administration's pro-industry stance.These updates show the ever-evolving landscape of the pharmaceutical and biotech industries. Stay tuned for more important news and developments in the field.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. J&J is currently involved in a legal battle with Samsung Bioepis, alleging unlawful sublicensing of a Stelara biosimilar. Meanwhile, Takeda has made a significant investment in a new BridGene partnership aimed at targeting undruggable targets. In other news, Regeneron has made strides in developing a gene therapy that can restore hearing in patients with rare genetic deafness. However, Deerfield Management claims that Alcon is hindering Aurion Biotech's IPO progress. Additionally, Trilink is offering mRNA designs that ensure reliable performance across various applications. There have also been reports of compounders suing the FDA, Reperio Therapeutics downsizing their staff, and discussions on how to support small molecule innovations in the industry. And if you missed it, recent developments include Trump threatening big pharma with tariffs, the FDA rehiring scientists, and advancements in pain treatment, RNA editing, and gene therapies being highlighted. Opportunities in neuroscience sales, regulatory affairs, and marketing are currently available for those interested. Thank you for tuning in to Pharma and Biotech Daily for the latest updates in 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.President Trump has threatened big pharma with tariffs unless they reshore manufacturing. He also refused to promise pharma executives that he would hamstring the IRA's drug negotiation program. RNA editing is fueling hope for rare and common diseases, with experts calling for more efficiency and breakthroughs in delivery methods. The FDA is rehiring scientists after Trump's firing spree, with around 300 staff being asked to return. Vertex's Journavx is changing the pain treatment landscape, but opioids are still prevalent. Trilink offers mRNA designs for reliable performance in various applications. In other news, a small Harvard start-up is fighting antimicrobial resistance, and OpinionAI is focusing on small molecules in the I&I space. Bluebird is going private, Mirum receives FDA approval for a rare disease, and PhRMA is meeting with Trump on various policies.Vertex's Journavx is changing the landscape of pain treatment, but opioids are still widely used. Non-opioid pain therapies, including Journavx, have been approved by the FDA, but their uptake remains uncertain. Meanwhile, RNA editing is showing promise in clinical trials for treating rare and common diseases, and artificial intelligence is making small molecules more attractive in the inflammatory and immunology disease space. The FDA is facing low morale after job cuts under Trump's administration, raising concerns about delays in new medicine approvals. Additional news includes Sanofi challenging Novo with an FDA approval for a biosimilar, FDA rare cancer approvals, and Lead passing on an option for Arcus' cancer drug.Thank you for tuning in to Pharma and Biotech Daily.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##Title: Pfizer and BioNTech seek FDA approval for COVID-19 vaccine boosterPfizer and BioNTech have announced that they are seeking authorization from the FDA for a booster dose of their COVID-19 vaccine. The companies have presented data showing that a third dose of the vaccine can significantly increase protection against the Delta variant.##Title: Moderna to supply 100 million more doses of COVID-19 vaccine to the USModerna has reached an agreement with the US government to supply an additional 100 million doses of its COVID-19 vaccine. The company will deliver the doses by the end of the year, helping to boost vaccination efforts across the country.##Title: AstraZeneca's COVID-19 antibody treatment shows promising results in clinical trialsAstraZeneca has announced that its COVID-19 antibody treatment has shown promising results in clinical trials. The treatment, which is designed to prevent severe disease and hospitalization, could provide an important new tool in the fight against the virus.##Title: Novartis receives FDA approval for new treatment for advanced breast cancerNovartis has received FDA approval for a new treatment for advanced breast cancer. The drug, which targets a specific genetic mutation, has been shown to significantly improve progression-free survival in patients with the disease.##Title: Roche announces positive results from phase 3 trial of Alzheimer's drugRoche has announced positive results from a phase 3 trial of its Alzheimer's drug. The drug, which is designed to target the underlying cause of the disease, showed significant improvement in cognitive function and daily living activities in patients with early-stage Alzheimer's.##Title: Johnson & Johnson to invest $6.5 billion in expanding vaccine production capacityJohnson & Johnson has announced plans to invest $6.5 billion in expanding its vaccine production capacity. The company aims to increase production of its COVID-19 vaccine as well as other vaccines in its portfolio, helping to address global supply shortages.##Title: Merck receives FDA approval for new treatment for certain types of lung cancerMerck has received FDA approval for a new treatment for certain types of lung cancer. The drug, which targets a specific genetic mutation, has been shown to improve overall survival in patients with advanced disease.##Title: Gilead Sciences announces collaboration with Novartis on HIV researchGilead Sciences has announced a collaboration with Novartis on HIV research. The companies will work together to develop new treatments for HIV, with a focus on addressing drug resistance and improving outcomes for patients with the virus.## Title: Eli Lilly receives FDA approval for new treatment for migraineEli Lilly has received FDA approval for a new treatment for migraine. The drug, which is administered through an injection, has been shown to provide rapid relief from migraine symptoms and reduce the frequency of attacks in patients with the condition.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##COVID-19 vaccine distribution challenges##As the world races to distribute COVID-19 vaccines, challenges arise in ensuring equitable distribution. Limited supplies, logistical issues, and vaccine hesitancy all contribute to the complexity of the distribution process. Governments and organizations must work together to address these challenges and ensure that vaccines reach all those in need.##FDA approves new cancer treatment##The FDA has recently approved a new cancer treatment that shows promising results in clinical trials. This treatment offers hope to patients with certain types of cancer who have not responded well to traditional therapies. The approval highlights the importance of ongoing research and innovation in the field of oncology.##Pharmaceutical company announces breakthrough in Alzheimer's research##A pharmaceutical company has announced a major breakthrough in Alzheimer's research, potentially paving the way for new treatments for this devastating disease. The discovery represents a significant advancement in our understanding of Alzheimer's and offers hope to millions of patients and their families.##Biotech firm receives funding for rare disease research##A biotech firm has secured funding to support research into a rare disease that affects a small but vulnerable population. This funding will enable the firm to continue its work in developing new treatments and ultimately improving the lives of those affected by this rare disease.##Regulatory approval granted for innovative gene therapy##Regulatory approval has been granted for an innovative gene therapy that has shown promising results in clinical trials. This therapy represents a new frontier in the treatment of genetic disorders and offers hope to patients who previously had limited treatment options. The approval highlights the potential of gene therapy as a transformative technology in healthcare.##Pharma company collaborates with academia on drug discovery##A pharmaceutical company has announced a collaboration with academia to accelerate drug discovery efforts. By combining industry expertise with academic research capabilities, the collaboration aims to identify and develop novel therapies for a range of diseases. This partnership demonstrates the power of collaboration in driving innovation in drug discovery.##Biotech startup receives grant for antibiotic development##A biotech startup has been awarded a grant to support its work in developing new antibiotics to combat antimicrobial resistance. This funding will allow the startup to continue its research and development efforts, with the ultimate goal of bringing new antibiotics to market. The grant highlights the importance of addressing the growing threat of antimicrobial resistance through innovative research initiatives.##Pharma company acquires biotech firm to expand pipeline##A pharmaceutical company has acquired a biotech firm in a strategic move to expand its pipeline of novel therapies. This acquisition will allow the company to access new technologies and research capabilities, strengthening its position in the competitive pharmaceutical market. The acquisition underscores the importance of strategic partnerships and acquisitions in driving innovation and growth in the industry.##Biotech company announces positive results from clinical trial##A biotech company has announced positive results from a clinical trial of its experimental therapy for a rare genetic disorder. The therapy showed promising efficacy and safety outcomes, raising hopes for patients with this debilitating condition. The results highlight the potential of precision medicine approaches in treating rare genetic disorders.##Pharma industry invests in digital health technologies##The pharmaceutical industry is increasingly investing in