Clinical Trial News
Psychedelics and Psychedelic-Assisted Psychotherapy: A Review of Clinical Applications
This article reviews the clinical application of psychedelic drugs in psychiatric disorders, focusing on MDMA, psilocybin, LSD, and ayahuasca. It highlights the resurgence of research into their therapeutic potential, supported by organizations like MAPS and the Heffter Research Institute, and discusses their efficacy in treating conditions such as PTSD, depression, and anxiety.
Roche and Bicycle Therapeutics Forge $1.7B Cancer Immunotherapy Alliance
• Roche's Genentech unit partners with Bicycle Therapeutics in a $1.7 billion deal to leverage innovative bicyclic peptide platform for cancer immunotherapy development, with a $30 million upfront payment.
• Bicycle's proprietary technology combines antibody-like targeting with small-molecule drug properties, offering unique advantages in manufacturing, dosing, and tissue penetration for cancer treatment.
• The collaboration focuses on discovering novel cancer immunotherapy targets, with Bicycle handling early development and Roche taking over clinical-stage programs.
NIH Initiates Clinical Trial of Remdesivir for COVID-19 in the U.S.
• The National Institute of Health (NIH) has begun a clinical trial of Gilead Sciences' remdesivir to treat COVID-19 in U.S. hospitals.
• The first participant is an American patient at the Nebraska Medical Center, who was quarantined from the Diamond Princess cruise ship.
• Clinical trials are also underway in China to evaluate remdesivir's efficacy against SARS-CoV-2, the virus causing COVID-19.
• U.S. health officials are preparing for potential significant disruptions due to the expected spread of COVID-19.
Clinical Trial Sponsors Face Mandate to Publish Decade of Missing Data
• A federal judge has ruled that government research agencies misinterpreted a law requiring clinical trial data publication, creating a 10-year gap.
• Universities, drug companies, and medical device manufacturers may need to release previously unpublished data from trials of unapproved drugs and devices.
• The ruling affects trials conducted between 2007 and 2017, potentially impacting hundreds to over a thousand noncompliant trials.
• Experts assert the decision enhances public access to clinical trial results, making it harder to conceal unfavorable outcomes.
Vifor Pharma and Fresenius Kabi Form Strategic Alliance to Address Iron Deficiency in China
• Vifor Pharma and Fresenius Kabi establish a joint venture with 55/45 ownership split to market intravenous iron products across China, targeting over 2,000 tier 3 hospitals.
• The partnership aims to address China's significant iron deficiency anemia burden, affecting an estimated 20% of the population, while reducing reliance on blood transfusions.
• The collaboration will reach over 45,000 healthcare professionals, including anesthesiologists and surgeons, focusing on patient blood management and nephrology care.
Digital Technologies Poised to Reverse Declining ROI in Pharmaceutical R&D
• Pharmaceutical R&D costs have nearly doubled from $1.1 billion in 2010 to $2.1 billion in 2018, while ROI has plummeted from 10.1% to 1.9%, prompting industry-wide concerns.
• AI, Big Data, and advanced analytics are emerging as key technologies to improve R&D productivity, with 80% of biopharma companies now implementing these solutions compared to 36% in 2017.
• Digital transformation is reshaping organizational structures, with 70% of surveyed firms reporting breakdown of internal silos and formal reorganization to accommodate new technologies.
FDA Grants Fast Track Status to BBO-8520 for KRAS G12C-Mutated NSCLC
• The FDA has granted fast track designation to BBO-8520, an oral agent under investigation for treating KRAS G12C-mutated metastatic non-small cell lung cancer.
• This designation aims to expedite the development and review of BBO-8520, addressing an unmet need in previously treated NSCLC patients.
• The decision was based on the drug's potential to improve outcomes in this specific genetic subgroup of lung cancer, where treatment options are limited.
Ensifentrine Shows Promise in Improving Lung Function and COPD Symptoms
• A Phase 2b trial of ensifentrine demonstrated statistically significant improvements in lung function in COPD patients.
• The study also met clinically relevant secondary endpoints, showing improvements in COPD symptoms.
• Ensifentrine is a first-in-class, inhaled, dual inhibitor of phosphodiesterase 3 and 4, acting as both an anti-inflammatory and bronchodilator.
• Verona Pharma anticipates an End-of-Phase 2 meeting with the FDA to discuss Phase 3 program design.
J&J Hit with $187M Punitive Damages in Landmark Talc Cancer Trial
• A New Jersey jury initially awarded $750 million in punitive damages against Johnson & Johnson in a talc-cancer case, later reduced to $187 million due to state law limitations.
• Four plaintiffs who developed cancer after using J&J's talc products were previously awarded $37 million in compensatory damages in the same trial.
• J&J's CEO Alex Gorsky made his first-ever jury trial appearance regarding talc litigation, while the company faces approximately 16,000 talc-related lawsuits amid ongoing safety concerns.
Immunology Market Evolution: Interleukin Inhibitors Rise as Biosimilars Reshape Treatment Landscape
• The immunology market has witnessed a significant shift with increasing sales of interleukin inhibitors and declining TNF inhibitor revenues, driven by biosimilar competition and improved safety profiles.
• Breakthrough research has expanded treatment options for previously underserved conditions, with notable approvals like Dupixient for atopic dermatitis and Benlysta for systemic lupus erythematosus.
• Biosimilars have generated over $3.4 billion in sales by 2019, with Pfizer's Inflectra leading at $671 million, though market access challenges persist, particularly in the US.