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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. 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.
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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.##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
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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.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.
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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.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.
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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 opened a national security probe on pharmaceutical imports, potentially leading to tariffs on these products. Johnson & Johnson reported strong earnings in Q1 thanks to certain drugs, while a phase III trial for BMS' Camzyos did not show new benefits. J&J CEO Joaquin Duato called for tax changes instead of tariffs to encourage drug manufacturing in the U.S. Merck is exploring oral peptide delivery through a new deal, while Boehringer Ingelheim is expanding its portfolio in the inflammation and immunology space. In response to Trump's tariff threats, J&J and other pharma companies are investing in U.S. manufacturing. 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 e Biotech world.Pfizer has dropped its lead obesity molecule, danuglipron, due to safety concerns regarding liver issues, leaving the company with only one molecule in its obesity pipeline. This decision has raised questions about the future direction of Pfizer's obesity research. Additionally, there are fears about the impact of recent firings at the Department of Health and Human Services on the FDA, with concerns about delays in drug approvals and increased political influence on regulatory decisions.In other news, Verve's base editor showed promise in lowering bad cholesterol levels in a phase Ib trial, and there are ongoing legal battles between Vanda and the FDA over off-label use of a drug for jet lag. Overall, the biotech industry is facing challenges and uncertainties in light of recent developments.The FDA is facing an uncertain future following a major overhaul by Kennedy, which included staff cuts that could threaten user fees, nearly half of the FDA's budget. Drug review delays and increased executive oversight are expected, with fears mounting about the agency's future direction. AI is enabling the development of smart antibodies that can more precisely target cancer cells while sparing healthy tissues.Upcoming FDA actions include a cell-based gene therapy for a rare skin disease and product expansions for Regeneron and Sanofi. Experts are concerned that FDA layoffs could trigger a mechanism that may set the industry back 35 years. Other news includes the FDA replacing some animal testing with AI and human 'organoid' lab models, changing attitudes towards the MMR vaccine, recent approvals in colorectal cancer, and more.Readers are encouraged to provide feedback on what topics they would like to see covered next.
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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.Lawmakers are focusing on boosting the US biotech industry while keeping China's growth in check. Novartis plans to invest $23 billion in US operations, potentially creating up to 1,000 new jobs. The FDA is exploring the use of AI and human 'organoid' lab models to replace some animal testing. The current tariffs and layoffs in the biopharma industry under the Trump administration have created uncertainty. Experts are advising companies to optimize process development for gene therapy products. Biopharma professionals are engaging in discussions on how nonprofit organizations can drive healthcare innovation amidst significant industry layoffs, such as Opthea cutting 65% of staff and Pfizer cutting 56%. The recent tariff pause by Trump has led to a late-day rally for pharma stocks. upcoming events include webinars on AI, regulation, and drug development laws, as well as strategies for surviving in the biotech downturn. Biotech leaders are calling on Senator Cassidy to address FDA cuts that could potentially set the US back 35 years.
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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.Pharma stocks had a turbulent day after Trump's tariff pause, with some stocks making a late-day recovery. However, there are concerns about potential FDA budget cuts that could severely impact drug access in the US. Biotech leaders are calling on Senator Cassidy to take action in response to these cuts, which have already caused delays and uncertainty in the regulatory process. Experts are warning that jeopardizing the FDA user fees program could have dire consequences.In other news, nonprofit organizations are playing a key role in driving innovation in healthcare. Tempest is currently seeking funding for a late-stage liver cancer asset, while Amgen's Uplizna has shown promising results in treating myasthenia gravis.Upcoming events include webinars on AI and regulation in drug development, as well as strategies for navigating the biotech downturn. On a less positive note, several biopharma companies have announced layoffs, including Vincerx and Reckitt Benckiser.Overall, the industry is facing challenges but also opportunities for growth and advancement.
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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. President Trump's announcement of 'major' pharmaceutical tariffs has caused market turmoil and a decrease in industry value. Analysts predict increased costs for medicines and potential negative effects on patient drug access. Pharmaceutical companies are preparing for potential financial impacts as they brace for the implications of the upcoming tariffs on their operations and bottom line.The pharmaceutical market is witnessing a significant decline in value due to President Trump's tariffs, with billions in market cap being shed. Analysts forecast increased costs for medicines as a result of the tariffs, posing challenges for the traditionally recession-resistant industry. Intense competition between drug rivals is evident, with companies like Eli Lilly experiencing significant drops in value. Wacker Biotech is offering their services as a partner for advanced therapies, amidst warnings about China overtaking the US in biotech and FDA job cuts under Trump's administration. Various developments in the biopharmaceutical industry are also shaping the landscape. Job openings in the sector are highlighted, urging readers to subscribe to the Biospace newsletter for updates on news and trends.
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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 pharmaceutical industry, traditionally seen as recession-resistant, may face challenges due to Trump's tariffs and the dominance of GLP-1s. Lexeo is moving forward with a gene therapy for Friedreich's ataxia after promising phase I/II data, while Rallybio is pivoting to a new antibody for rare autoimmune disorders. HHS Secretary Robert F. Kennedy, Jr. will not be speaking to the Senate health committee this week as scheduled. In other news, Merida is entering the autoimmune and allergy arena with a $121 million series A funding. Lilly is suing an Indianapolis spa for selling knockoff versions of its migraine drug Zepbound, and biotech shares are affected by the departure of FDA's Marks. Cardiovascular disease is back in the spotlight.
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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.##FDA Approves New Cancer DrugThe FDA has approved a new cancer drug that has shown promising results in clinical trials. This drug is expected to provide a much-needed treatment option for patients with this type of cancer.##Major Biotech Company Announces MergerA major biotech company has announced a merger with another company in the industry. This merger is expected to create a powerhouse in the biotech world, with the potential for groundbreaking research and development.##COVID-19 Vaccine UpdateThere have been new developments in the race for a COVID-19 vaccine. Several pharmaceutical companies are in the final stages of clinical trials, and there is hope that a vaccine will be available soon.##Drug Pricing Legislation PassesLegislation aimed at addressing drug pricing has passed in Congress. This legislation is expected to lower the cost of prescription drugs for consumers and improve access to affordable medication.##Biotech Startup Receives FundingA promising biotech startup has secured funding to further its research and development efforts. This funding will allow the company to continue its work on innovative therapies and treatments.##FDA Issues Warning About Opioid UseThe FDA has issued a warning about the dangers of opioid use. This warning comes amid a growing opioid crisis in the United States, and highlights the importance of safe prescribing practices.##New Gene Therapy Shows PromiseA new gene therapy has shown promise in treating a rare genetic disorder. This therapy has the potential to revolutionize treatment for patients with this condition, offering hope for improved outcomes.##Pharma Company Launches Patient Assistance ProgramA pharmaceutical company has launched a patient assistance program to help those in need access necessary medications. This program aims to provide support for patients facing financial barriers to treatment.##Biotech Breakthrough in Alzheimer's ResearchA biotech company has made a breakthrough in Alzheimer's research, uncovering new insights into the disease. This discovery could lead to new treatment options for Alzheimer's patients in the future.
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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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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.
- Visa fler
