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| Essential Reading AbbVie’s schizophrenia drug failure AbbVie's experimental schizophrenia drug emraclidine has failed to meet primary endpoints in two mid-stage clinical trials, leading to a significant decline in the company's stock value. The trials aimed to assess the drug's efficacy in reducing symptom severity during acute psychotic episodes but did not achieve the desired outcomes. AbbVie had acquired emraclidine via an $8.7 billion deal with Cerevel Therapeutics in 2023, anticipating substantial revenue. In contrast, Bristol Myers Squibb's schizophrenia treatment Cobenfy, approved by the FDA in September, has gained a competitive advantage with its shares rising by more than 10 percent. AbbVie is now analyzing the trial data to determine future steps. EU associations question Waste Water Directive The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of the European Self-Care Industry (AESGP) have issued a joint statement regarding the EU’s Urban Waste Water Treatment Directive. Though they support the directive's goals to reduce water pollution, they express concerns about its potential impact on patient access to medicines and the competitiveness of the pharmaceutical sector. They argue that the directive’s approach, which places financial responsibility solely on the pharmaceutical and cosmetics industries, does not fully adhere to EU principles of proportionality, non-discrimination, and the “polluter-pays” principle. The statement calls for a more equitable implementation that involves all sectors contributing to micropollutants in water, ensuring a fair and effective strategy to address water pollution. |
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| Also in the News... FDA removes clinical hold on Novavax's IND application for COVID-19 and influenza vaccine candidates.
Medable launches generative AI capabilities to help sponsors and clinical research organizations accelerate digital and decentralized trials.
Nutcracker Therapeutics introduces new precision contract research, development, and manufacturing capabilities for mRNA drug developers.
AdaptImmune plans to initiate rolling BLA submission for advanced or metastatic synovial sarcoma and MRCLS treatment lete-cel following positive results in trials.
GenScript Biotech strengthens position in APAC, establishing operations and logistics facility in Sydney, Australia. |
| Upcoming Brand Events Bioprocessing Revisited: Applying the Lessons from mAbs Production to Advanced Therapeutics Manufacturing Wednesday, December 4, 2024 | 11am EST | Register Now Empowering you to master control, predictability, and efficiency, partnering in your digital transformation Monday, December 9, 2024 | 6pm CET | Register Now |
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| More from The Medicine Maker Who Are the Best Pharma Companies of 2025? It’s nearly the end of 2024, which means it’s time to vote for The Medicine Maker Company of the Year Awards. Which companies will be the ones to watch in 2025? Vote now! Lessons Learned in Leadership: Kristina Kempf Kristina Kempf at PTC Therapeutics discusses the importance of strong female role models and how she refused to accept systemic barriers in her career. Read the article Inside the Industry’s New RTU Alliance Schott, Gerresheimer, and Stevanato recently launched a strategic alliance to promote ready-to-use (RTU) technologies for vials and cartridges. Read the article How Can Industry Address AMR? As world leaders commit to an ambitious reduction in AMR-related deaths, we ask is five years enough time to achieve it? Read the article Genetic Tailoring With CRISPR How CRISPR can change the way we design and produce antibodies. Read the article |
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