Merck’s Keytruda, the top-selling drug in the world, is facing a patent fight over its new injectable version. The drug, known for its effectiveness in treating lung cancer, melanoma, and other cancers, has generated nearly $30 billion in sales last year. Merck is planning to launch an easier-to-administer injectable version of Keytruda pending FDA approval, with a target launch date of October 1. However, San Diego-based Halozyme has filed a lawsuit against Merck in U.S. District Court, alleging patent infringement over the injectable formulation. Halozyme, known for its partnerships in creating injectable versions of medicines, claims that Merck used its hyaluronidase technology without a licensing deal. The lawsuit comes at a critical time for Keytruda, as the drug is facing patent expirations in the near future, potentially opening the door for biosimilar competition. Merck has announced plans to invest $1 billion in a new factory in Delaware to produce biologic drugs, including the new injectable version of Keytruda.
The annual meeting of the American Association of Cancer Research brought together over 21,000 attendees to showcase groundbreaking research in the fight against cancer. One of the key highlights from the event was the use of artificial intelligence in cancer diagnostics, with AI models showing promising results in predicting cancer risks and classifying different types of cancers from images alone. Boehringer Ingelheim presented data on its drug zongertinib, targeting HER2 mutations in non-small cell lung cancer, showing positive outcomes with fewer side effects. Additionally, innovative immunotherapies and diagnostic tools were discussed, including a study on the effectiveness of the HPV vaccine in preventing cervical cancer with just one dose.
In the biotech and pharma sector, Sudip Parikh, CEO of the American Association for the Advancement of Science, testified to the Senate Appropriations Committee about the impact of budget cuts on biomedical research. Parikh criticized the Trump administration’s decisions, stating that they could lead to fewer treatments for cancer and other diseases, potentially jeopardizing America’s leadership in biomedical research. A study by economists at American University warned that significant reductions in research funding could have long-term negative effects on government revenues. The FDA also approved Abeona Therapeutics’ gene therapy Zevaskyn for a rare genetic condition causing fragile skin.
Verily, Alphabet’s health and AI company, received a substantial grant from the Michael J. Fox Foundation to create a large molecular dataset of Parkinson’s patients, aiming to accelerate new treatments for the disease. In the field of medtech, diagnostics company Predicta Biosciences launched its GenoPredicta test for multiple myeloma, using whole genome sequencing to guide treatment decisions. The test offers a less invasive alternative to traditional diagnostic methods, providing more accurate and personalized results.
A recent study linked exposure to phthalates, chemicals found in plastics, to an increased risk of heart disease and hundreds of thousands of related deaths annually. Novo Nordisk announced plans to sell low-cost versions of its weight-loss drug Wegovy through telehealth companies, following the end of a FDA-permitted shortage. Overture Life, a company specializing in IVF automation, secured $21 million in funding to further develop its technology.
On the public health front, a study highlighted the damaging effects of certain gut bacteria on colon cancer rates in younger individuals. Chinese biotech company Akeso received approval in China for a drug challenging Merck’s Keytruda, with Summit Therapeutics partnering for its U.S. development. The impact of Trump’s science funding cuts was underscored by the potential euthanization of research animals due to lack of funding. Health system operating margins dropped below 1% in March, indicating financial challenges in the industry.
In conclusion, the healthcare and biotech industries continue to see advancements and challenges, with innovative research and treatments paving the way for improved patient outcomes. Collaboration between companies, research institutions, and regulatory bodies is crucial in driving progress and addressing complex health issues.
