News Item
Biotechnology & Applied Microbiology
Asher Mullard
Summary: After 35 years since the FDA approved the first monoclonal antibody, these biologics now make up nearly one fifth of the agency's new drug approvals each year.
NATURE REVIEWS DRUG DISCOVERY
(2021)
News Item
Multidisciplinary Sciences
Myriam Vidal Valero
Summary: US regulatory agency approves GSK's vaccine, marking the end of a decades-long quest.
News Item
Biochemistry & Molecular Biology
Thiago Carvalho
Summary: Nature Medicine investigates the latest advancements in translational and clinical research, featuring ongoing clinical trial data of mosunetuzumab in patients with relapsed or refractory follicular lymphoma.
News Item
Multidisciplinary Sciences
Asher Mullard
Summary: Pharmaceutical companies are submitting their anti-amyloid drug candidates for approval, but concerns remain over the controversial precedent set by Biogen's aducanumab.
News Item
Biochemistry & Molecular Biology
Thiago Carvalho
Summary: Nature Medicine reports the latest translational and clinical research news on a newly approved JAK and TEC inhibitor for the treatment of autoimmune disease alopecia areata.
Article
Pharmacology & Pharmacy
Islam R. Younis, Pooja Manchandani, Hazem E. Hassan, Hisham Qosa
Summary: Characterizing interactions between new molecular entities (NMEs) and drug transporters is crucial for drug development, and the FDA has shown an increasing emphasis on this. Trends in transporter-based PMRs/PMCs issued by the FDA between 2012 and 2021 indicate a rise in requests for clinical evaluation, in vitro assessment, and modeling and simulation assessment. Fulfilling these requests can lead to labeling updates and improved drug safety.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Chemistry, Medicinal
Saghir Ali, Jia Zhou
Summary: The objective of this review is to provide an update on fluorine-containing drugs approved by the FDA in the past five years. A total of fifty-eight fluorinated entities were accepted for the diagnosis, mitigation, and treatment of various diseases. The drugs are categorized based on their therapeutic areas and information about their trade name, approval date, active ingredients, developers, indications, and mechanisms of action are provided. This review is expected to inspire drug discovery and medicinal chemistry research in both industrial and academic settings, leading to the discovery of new drugs in the future.
EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY
(2023)
Review
Pharmacology & Pharmacy
Debora Nunes, Joana A. Loureiro, Maria Carmo Pereira
Summary: Alzheimer's disease is the most common form of dementia, requiring the development of more effective treatment strategies. Approved drugs for treatment have limited effectiveness and unwanted side effects. Utilizing drug delivery systems can enhance drug efficacy and reduce unwanted side effects.
Review
Chemistry, Medicinal
Rekha Tamatam, Dongyun Shin
Summary: Chirality plays a significant role in the design, discovery, and development of new drugs. Pharmaceutical compounds exist as racemic mixtures, but their enantiomers have distinct biological properties. Asymmetric synthesis has become crucial for producing single-enantiomeric drugs, involving the conversion of achiral starting materials into chiral products. This review focuses on the methods used to synthesize FDA-approved chiral drugs from 2016 to 2020, with an emphasis on asymmetric synthesis through chiral induction, resolution, or chiral pool strategies.
Article
Allergy
Katherine E. Clarridge, Stacy J. Chin, Kelly D. Stone
Summary: The U.S. FDA regulates various products to ensure their safety and effectiveness. The FDA-approved drug labeling is an important tool for conveying information about drug use. Providers should be familiar with the format of prescribing information and be cautious about off-label drug use.
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
(2022)
Review
Biochemistry & Molecular Biology
Alexander C. Martins, Fernando Albericio, Beatriz G. de la Torre
Summary: The year 2022 saw the successful control of the COVID-19 pandemic in most countries through social and hygiene measures and vaccination campaigns. However, there was a decrease in total drug approvals by the FDA, particularly for small molecules. The Biologics class, on the other hand, maintained its figures with the authorization of 15 novel molecules.
Article
Chemistry, Multidisciplinary
Sergey Shityakov, Ekaterina V. Skorb, Carola Y. Foerster, Thomas Dandekar
Summary: This study utilized a scaffold searching approach based on the known Aβ inhibitor tramiprosate to identify potential Aβ inhibitors, menadione bisulfite and camphotamide, with improved binding affinity and blood-brain barrier permeation. The data was confirmed through molecular dynamics simulations, suggesting these lead candidates could be further validated and potentially tested in clinical trials for Alzheimer's Disease.
FRONTIERS IN CHEMISTRY
(2021)
Article
Clinical Neurology
Monica Moreno, Chelsea R. Kline, Kerry Lanigan, Beth Kallmyer, Kristen Clifford, Sam Fazio
Summary: With the emergence of new clinical trial data on disease-modifying therapies in Alzheimer's disease (AD) studies, the Alzheimer's Association sought the perspectives of individuals living with AD on significance and new treatments. Thirty members of the Alzheimer's Association's National Early Stage Advisory Group participated in a focus group or online survey to gain insights on their desires for a groundbreaking treatment that could halt the progression of their disease at an early stage. Participants emphasized the importance of considering personal significance in addition to clinical significance and highlighted the need for accessibility, education, choice, and affordability moving forward.
ALZHEIMERS & DEMENTIA
(2023)
Article
Oncology
Emmanuelle Jacquet, Ghania Kerouani-Lafaye, Francoise Grude, Sergio Goncalves, Annie Lorence, Florence Turcry, Liora Brunel, Laetitia Belgodere, Adrien Monard, Gaelle Guyader, Lotfi Boudali, Nicolas Albin
Summary: This study examines the use of the ATU system in oncology, showing that 56.2% of drugs that received European MA were granted ATU, benefiting 16,927 patients. Through ATU, 69.4% of the drugs were made available early, an average of 203 days before FDA approval and 428 days before EMA approval.
EUROPEAN JOURNAL OF CANCER
(2021)
Review
Pharmacology & Pharmacy
Michael S. Kinch, Zachary Kraft, Tyler Schwartz
Summary: In 2021, the FDA approved 60 new molecular entities (NMEs), reaching the highest level in the post-PDUFA era. Among these NMEs, 49 utilized the incentives of the Orphan Drug Act or obtained approval under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Although the number of registered clinical trials was lower than the 2020 peak, it remained within the 5-year running average. The rate of industry consolidation and turnover, however, raised concerns about the long-term sustainability of organizations involved in clinical development.
DRUG DISCOVERY TODAY
(2022)