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 e Biotech world. The FDA is facing a potential "catastrophic collapse" due to massive layoffs that are endangering its user fee program, which provides nearly half of its yearly funding. More than half of the senior leadership at the agency has left, leading to a lack of communication, transparency, and human decency. The agency is at risk of losing its funding and ability to support its operations and employee salaries. In other news, Amgen has won an expansion for Uplizna as the first drug for IgG4-related disease, Lilly has made a pact with Sangamo worth a potential $1.4 billion, and Trilink offers custom guide RNAs for CRISPR workflows. The cell and gene therapy sector has seen a 30% investment surge despite market challenges.
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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. Pharma industry tensions rise as Trump tariffs miss sector for now. FDA's interim CBER head appointed after key resignation. Xaira Therapeutics hires top AI academic. Novavax's COVID-19 shot review deadline missed by FDA. Trilink offers guide RNA for CRISPR workflow. Biotech sector sees investment surge. Beigene scraps candidate, Sarepta's gene therapy on hold in Europe. Biopharma professionals work long hours.In other news, there are safety concerns in Duchenne treatment. Democrats challenge Trump health cuts. And there are job opportunities in the biopharma industry.
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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 the Pharma and Biotech world.Pharmaceutical companies are pushing back against Trump's tariffs, requesting staggered tariffs as Trump plans for a more aggressive set of tariffs on April 2. Democrats are criticizing Trump's health cuts and policies, with lawsuits being filed and Senator Cory Booker speaking out against the administration. The FDA is facing turnover and layoffs, with concerns about the "revolving door" of talent between the agency and biopharma companies. Denali is making progress in crossing the blood-brain barrier for neuroscience treatments. In the midst of these developments, the biotech industry is seeing growth in cell and gene therapy investments. Despite these challenges, companies like Trilink are offering solutions for accelerating therapy discoveries with custom guide RNAs for CRISPR workflows.In other news, Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, was forced out after clashing with Health and Human Services Secretary Robert F. Kennedy Jr. over transparency issues. Marks, known for his work on innovative therapies like cell and gene therapy, resigned due to the lack of desired truth and transparency from Kennedy. This event has caused turmoil in the biopharma industry, leading to a drop in biotech shares. Additionally, massive layoffs are expanding across HHS as part of Kennedy's plan to remove up to 10,000 staff members. The departure of Marks has raised concerns about the future of the FDA and the industry as a whole. Experts fear that the agency is losing institutional knowledge and experienced leaders, which could have negative implications for drug development and safety. Calls for Kennedy's dismissal have been made by analysts following Marks' resignation. The industry is now facing uncertainty and instability in the wake of these events.
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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. Former FDA Commissioner Robert Califf has spoken out as layoffs continue at the FDA, with the latest cuts affecting the Center for Drug Evaluation and Research (CDER). The layoffs are part of a larger reduction of 10,000 jobs at the Department of Health and Human Services. In addition, biopharma markets are in chaos following the departure of Peter Marks from the FDA's Center for Biologics Evaluation and Research (CBER).Carisma Therapeutics has laid off most of its staff and is considering selling off assets and winding down fully. Analysts are calling for President Donald Trump to reconsider his appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services. The departure of Peter Marks from the FDA has caused shares in the biopharma markets to tumble.Trilink offers custom guide RNAs (grRNAs) for CRISPR-based therapy discoveries. Despite market challenges, the cell and gene therapy sector has seen a 30% investment surge. Companies like Tenaya are cutting their workforce to fund development of gene therapies.Overall, the biopharma industry is facing uncertainty and instability as layoffs continue and key figures depart from regulatory agencies.
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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 and Alnylam have received FDA approval for the first RNAi treatment for hemophilia, with the drug, Qfitlia, indicated for both hemophilia A and B. This approval is significant as it can be given regardless of the presence of neutralizing antibodies against clotting factors VIII or IX. However, the sudden departure of FDA director Peter Marks has caused uncertainty in the biopharma industry. In other news, Vertex has cut a diabetes asset but analysts remain optimistic about their phase III option. Lilly's RNA silencer has shown promising results in lowering a key cardiovascular biomarker. Trilink is offering custom guide RNAs for CRISPR workflow to accelerate therapy discoveries. Despite market challenges, the cell and gene therapy sector has seen a 30% investment surge. Companies like Amgen, Aldeyra, and Argenx are among those with upcoming FDA actions. Arbutus has announced layoffs, while big pharmas are pushing boundaries in radiopharmaceuticals. Michelle Werner of AltoRNA is focused on making better drugs. Safety questions are looming in Duchenne as Dyne and Wave plan FDA filings. There are job opportunities available in data management and program leadership within the biopharma industry.Moving on to other news, several big pharmaceutical companies such as Novartis, Bayer, AstraZeneca, Bristol Myers Squibb, and Eli Lilly are competing in the radiopharmaceuticals market, which is projected to be worth over $13 billion by 2033. The FDA is expected to announce decisions on therapies for dry eye disease soon. Michelle Werner, CEO of AllTrna, is focused on developing trna-based treatments for various diseases.Safety concerns are emerging in the Duchenne muscular dystrophy space as companies like Dyne and Wave plan FDA filings. The EU rejected Lilly's Alzheimer's drug Kisunla, Biontech's bispecific showed promise in treating SCLC patients, and Wave's duchenne exon-skipper reversed muscle damage in a mid-stage trial. Job opportunities within the biopharma industry were also highlighted for those interested.Thank you for tuning in to Pharma and Biotech daily - keeping you updated on all the latest news in 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 and Biotech world.The European Union has rejected Lilly's Alzheimer's drug Kisunla, citing potential risks of brain swelling and bleeding. This decision follows a similar rejection of a rival drug, Leqembi. Novo Nordisk is facing challenges in its weight loss business due to compounded versions of its drug Semaglutide making up a significant portion of the market. Milestone Pharmaceuticals experienced a setback when the FDA issued a complete response letter for its tachycardia drug Cardamyst. The company is now focusing on restructuring and streamlining operations.Merck's injectable Keytruda has shown promising results in a pivotal trial, and BioNTech's bispecific treatment has elicited positive responses in the majority of patients with small cell lung cancer. Novo Nordisk's stock dipped after disappointing weight loss results for Cagrisema, and Biogen and Eisai's drug Leqembi faced setbacks in the UK and Australia. In other news, United States Pharmacopeia is offering career opportunities in various fields including science, technology, regulatory affairs, and quality assurance. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology industries.
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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. The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., has revealed intentions to reduce 10,000 positions and restructure departments. The appointment of vaccine critic David Geier to investigate vaccine safety within the CDC has also been announced. Soleno has recently obtained FDA approval for a medication designed to address hyperphagia in Prader-Willi syndrome patients. Meanwhile, Johnson & Johnson's combination therapy for lung cancer has displayed encouraging outcomes. A power struggle at Aurion has resulted in Alcon taking control, amidst allegations of impeding Aurion's IPO plans. Opportunities in the biopharma industry are available at the United States Pharmacopeia, alongside updates on biopharma layoffs and industry advancements. That's all for today's episode. Stay tuned for more essential news from the world of Pharma and Biotech. Thank you for listening.
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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. Today, we will discuss the upcoming challenge in the pharmaceutical industry of manufacturing oral GLP-1 medications, following previous issues with injectable GLP-1s. Companies like Eli Lilly and Novo Nordisk are competing for dominance in the weight loss space with these medications. Additionally, we will explore the potential impact of Trump's proposed tariffs on EU pharmaceutical companies. Humira, once a top-selling drug, is now facing declining sales as doctors switch to biosimilars and new therapies. We will also touch on the potential benefits of single-use bioreactor technology in accelerating drug manufacturing. Lastly, there are updates on various companies' financial commitments and layoffs in 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.President Trump has nominated Susan Monarez as the new head of the CDC, facing challenges such as a measles outbreak that has already resulted in two deaths. Merck commits nearly $2 billion for an oral lipid-lowering drug, joining other companies targeting lipoprotein(a). GSK is studying the impact of their shingles vaccine, Shingrix, on reducing dementia risk. Cassava has ended their Alzheimer's program for Simufilam after years of controversy. The average life sciences salaries have increased by 9% in 2024, but bonuses and equity values have dropped. Trump has doubled down on the threat of tariffs on pharmaceuticals. In other news, Opthea and Unity have failed to unseat Regeneron's Eylea in vision disorders, while Alector will be laying off 13% of its workforce. AstraZeneca is making a potential $10 billion commitment to China despite political pressure. Opportunities in the life sciences industry are available at companies like Oncothera, Dyne Therapeutics, Amgen, and Novo Nordisk.
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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.AbbVie has filed a lawsuit against Genmab, alleging that they have unlawfully used trade secrets to advance the development of antibody-drug conjugates through a company they acquired. On another note, AstraZeneca has made a significant investment of $2 billion in a Chinese obesity drug, despite facing political pressure and an ongoing fraud investigation. Novo is also entering the competition by placing a $2 billion bet on a triple agonist obesity drug from China. Shifting gears, the field of xenotransplantation is being explored as a potential solution to the organ shortage crisis. Companies are delving into gene editing and next-generation antibodies to pave the way for animal-to-human transplants. Overall, there are various opportunities for professionals in the pharmaceutical industry at companies like AbbVie and Genscript.
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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 CDC has rescheduled a vaccine meeting for April, while President Trump is considering Texas Republican Michael Burgess as the new director of the agency. J&J's Tremfya has won approval for expansion in treating Crohn's disease, while Adaptimmune is facing financial uncertainty despite sales of its T cell therapy. Alnylam's Amvuttra has been approved as the first RNAi silencer for a rare type of cardiomyopathy, setting up competition with Pfizer and BridgeBio. Sino Biological has developed reagents for the 2025-2026 influenza vaccine strains. In other news, J&J plans to boost US manufacturing following tariff threats, Novartis' Fabhata has been approved as the first therapy for a rare kidney disease, and Sanofi commits up to $1.9 billion for Dren Bio's bispecific antibody for autoimmune diseases. Paratek has acquired Optinose for up to $330 million, Purdue Pharma has filed for bankruptcy again to support an opioid settlement, and Novartis' Zolgensma has been found effective in older children.The FDA has approved Alnylam's Amvuttra as the first RNAi silencer for a rare type of cardiovascular disease called ATTR-CM, following the approval of BridgeBio's Attruzy for the same condition. This approval has sparked a three-way race in the rapidly expanding space, with Pfizer's Tafamidis also in the competition. Alnylam is optimistic about Amvuttra's unique mechanism of action, which targets the disease at its source by rapidly reducing the disease-causing TTR protein. This approval comes after Attruzy was also approved for polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in June 2022. This development has brought cardiovascular disease back into the spotlight, with other companies launching new drugs and treatments for various heart conditions.
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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 committed up to $1.9 billion to acquire Dren Bio's bispecific antibody for autoimmune disease, adding to its investments in the immunology portfolio. The deal comes after the tragic death of a patient who had taken the gene therapy Elevydys, prompting the Duchenne patient community to vow to push on. Paratek Pharmaceuticals has acquired Optinose for up to $330 million, while Senate Democrats demand the return of fired CDC staff. Sino Biological has developed recombinant antigens for the 2025-2026 influenza vaccine strains, and Purdue has filed for bankruptcy to support a $7.4 billion opioid settlement. Doctors continue to rally behind vaccines amidst doubts and misinformation, and Novartis' intrathecal Zolgensma has shown effectiveness in older children. TC Biopharm and Cargo have enacted steep workforce reductions. Pharmaceutical companies are also preparing for upcoming events, including webinars on AI regulation and drug development. Job opportunities in the pharmaceutical industry are available at companies like Takeda, Eli Lilly and Company, and Novo Nordisk.
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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.Roche has made a $1 billion investment in Oxford Biotherapeutics to gain access to their antibody-drug conjugate platform for cancer targets. Cargo has laid off 90% of its staff and is exploring potential business combinations. Trump is considering budget cuts to the CDC's HIV prevention program, which could impact HIV drugmakers like Gilead and Merck. The rise of GLP-1 weight loss drugs is compared to the early days of PD-1 inhibitors, with differences in the market suggesting history may not repeat itself. Sino Biological has developed recombinant antigens for the 2025-2026 influenza vaccine strains. Servier has acquired a solid tumor asset in a deal with Black Diamond.The text discusses the similarities between the rise of GLP-1 weight loss drugs and PD-1 inhibitors in the pharmaceutical industry. It also explores the impact of ongoing conflicts on drug development, highlights a new company, Mirador, focusing on inflammatory and fibrotic diseases, and looks at drugs facing patent cliffs. Additionally, it mentions Wacker Biotech as a partner for advanced therapies and provides updates on various pharmaceutical companies.Thank you for tuning in to Pharma and Biotech daily. Stay informed with us for more updates on the latest news in 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.## Sarepta's DMD gene therapy patient dies, causing a 22% drop in shares.Sarepta experienced a significant setback as a patient participating in their DMD gene therapy trial tragically passed away, leading to a 22% decrease in their shares.## Arbor raises $73.5 million for gene editing research.Arbor successfully secured $73.5 million in funding to further their research in gene editing, showcasing the growing interest and investment in this innovative field.## Opko and Entera collaborate on oral GLP-1/glucagon drug development.Opko and Entera have joined forces to collaborate on the development of an oral GLP-1/glucagon drug, combining their expertise to potentially revolutionize treatment options for patients.## Mirador aims to be a leading I&I breakthrough by 2030.Mirador has set ambitious goals to become a leading breakthrough in the field of inflammation and immunology by the year 2030, highlighting their commitment to advancing healthcare solutions.## Sino Biological offers reagents for 2025-2026 influenza vaccine strains.Sino Biological is providing reagents for the upcoming 2025-2026 influenza vaccine strains, contributing to the global efforts to combat infectious diseases and protect public health.## AstraZeneca invests $1.35 billion in subcutaneous cancer drugs with Alteogen alliance.AstraZeneca has made a substantial investment of $1.35 billion in subcutaneous cancer drugs through a strategic alliance with Alteogen, signaling their dedication to advancing oncology treatments.## DYNE's Duchenne exon skipping oligomer shows promising clinical effect.DYNE's Duchenne exon skipping oligomer has demonstrated promising clinical effects, offering hope for patients with this debilitating genetic disorder and potentially paving the way for new treatment options.Thank you for tuning in to Pharma and Biotech daily, where we bring you the latest updates and developments shaping the pharmaceutical and biotechnology industries. Stay informed and stay ahead in the world of healthcare innovation.
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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 recently made a significant investment of up to $1 billion in cell therapy through the acquisition of esobiotec. This move is part of AstraZeneca's larger strategy to expand in the cell therapy space, positioning itself to be a major player in the market. Dyne is also looking to file for accelerated approval for its Duchenne exon skipping oligomer, while Taiho Pharmaceutical has acquired ADC partner Araris for up to $1.1 billion. Alnylam is expected to enter the transthyretin amyloid cardiomyopathy market, which is projected to reach $11.2 billion by 2030.Sino Biological has developed reagents for the 2025-2026 influenza vaccine strains, offering a range of recombinant proteins for vaccine development. The pharmaceutical industry is seeing significant activity in various therapy areas, with companies making strategic investments and advancements in research and development.Alnylam is awaiting approval for their drug Amvuttra in the transthyretin amyloid cardiomyopathy market, which is currently dominated by Pfizer and BridgeBio. The obesity drug market is becoming increasingly competitive, with companies focusing on overall health benefits rather than just weight loss. Biopharma companies are now exploring the use of CAR T cell therapies for autoimmune disorders, with several readouts expected this year. Ionis and Ultragenyx are competing to develop treatments for Angelman syndrome, while Neuren is trying to catch up.Overall health outcomes are becoming more important in the obesity drug market, with successful studies in therapeutic areas like cardiovascular and sleep apnea providing a market advantage. Other news includes flu vaccine recommendations from the FDA and updates on drugs for alcohol use disorder, plaque psoriasis, breast cancer, and weight loss. The biopharma industry continues to evolve, with readers encouraged to provide suggestions for future coverage topics.
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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. Altimmune, a biopharmaceutical company based in Maryland, has announced plans to test an investigational drug based on GLP-1 for the treatment of alcohol use disorder. This drug is also being studied by Eli Lilly and Novo Nordisk for alcohol- and liver-related conditions. Altimmune joins these companies in exploring the potential of GLP-1 agonists for this indication. The recommendations for flu vaccine usage were recently made by the FDA in a closed session involving representatives from CBER, the CDC, and the Department of Defense.In other news, Pfizer has ended a trial for an early-stage cancer drug, Sutro has cut half of its staff and deprioritized a drug for ovarian cancer, and Pliant has implemented a poison pill strategy. Additionally, Wacker Biotech is offering services for advanced therapies, including process development and production of DNA and RNA. The biotech industry continues to see shifts and developments in various companies and research 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 Trump administration has withdrawn CDC nominee Dave Weldon at the last minute, while NIH and FDA picks advance. Acelyrin has implemented a poison pill strategy to prevent Tang Capital from acquiring the company. Johnson & Johnson and Legend Biotech are investing $150 million to increase Carvykti production. Mallinckrodt and Endo have announced a $6.7 billion merger. Wacker Biotech offers services for advanced therapies. Other news includes updates on Amgen's Uplizna, J&J's talc lawsuit, and Roche's obesity play.
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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. Bluebird bio has made the decision to go private in order to restructure and focus on long-term growth amidst declining valuations and funding challenges in the biotech industry. This move reflects a strategic shift in response to the current market conditions. Johnson & Johnson continues to face legal battles over talc products, with a pending ruling that could potentially resolve the issue. This ongoing litigation highlights the importance of product safety and regulatory compliance in the pharmaceutical industry. In other news, Viking has secured a supply of an obesity pill candidate, demonstrating a commitment to addressing unmet medical needs in the field of obesity treatment. Roche has also made a significant play in the obesity market with a potential $5.3 billion pact, signaling confidence in the potential of this therapeutic area. The COVID-19 pandemic has had lasting impacts on the life sciences sector, prompting companies to adapt and innovate in response to changing market dynamics. The industry continues to evolve in light of these challenges, driving progress and innovation in healthcare. Overall, these developments underscore the dynamic nature of the pharmaceutical and biotech industries, highlighting the importance of strategic decision-making and adaptability in a rapidly changing 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 and Biotech world.Bristol Myers Squibb (BMS) has acquired 2seventy, the partner of Abecma, for $286 million, ending their cost-sharing agreement. Abecma generated $406 million in 2024, with BMS paying $43 million to 2seventy as part of their profit-sharing agreement.Beam Therapeutics has achieved genetic correction in AATD, while Viking secured a 1 billion supply of an obesity pill candidate. Novavax, Roche, and other companies are also making significant moves in the industry.The editorial reflects on the five years of COVID-19 and its ongoing impacts on the life sciences industry. Stay tuned for more updates on these developments and more in the world of Pharma and Biotech.
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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's next-generation weight loss drug, cagrisema, has disappointed once again with lower-than-expected weight loss results. The latest data showed only a 15.7% weight loss in patients with diabetes after 68 weeks, below the company's projections. This news has caused Novo's stock to dip. Additionally, side effects associated with GLP-1-based obesity drugs are turning patients away from this type of treatment. Despite efforts to mitigate these side effects, studies show that various factors are causing patients to discontinue treatment.In other news, Johnson & Johnson's oral IL-23R blocker has set a new standard in plaque psoriasis treatment, outperforming Bristol Myers Squibb's Sotyktu. BMS's Sotyktu did, however, notch a phase III win in psoriatic arthritis. Novo is also conducting studies on GLP-1s for addiction, limited to ongoing phase II trials. Overall, the landscape of weight loss and skin condition treatments is evolving, with new drugs showing promise and competition heating up in the market.Drugmakers are focusing on reducing the side effects of GLP-1-based obesity drugs to address high discontinuation rates among patients. Novavax is applying lessons learned from the COVID-19 pandemic as it looks towards developing other novel vaccines. The FDA faces a challenging decision on biomarker-based label restrictions for certain cancer drugs, while J&J has axed a late-stage depression trial due to underwhelming efficacy.Other news includes AstraZeneca's positive data on Imfinzi for stomach cancer and Takeda's drug reducing the need for blood withdrawals in clinical trials. Novavax is also working with pharma partners to bring new vaccines to market. The FDA is dealing with staff and site turnover, and more job opportunities in the biopharma industry are available.Readers are encouraged to provide feedback on what topics they would like to see covered in future articles.
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