Antibiotic Development: Lessons from the Past and Future Opportunities.

The challenge of antimicrobial resistance is broadly appreciated by the clinical and scientific communities. To assess progress in the development of medical countermeasures to combat bacterial infections, we deployed information gleaned from clinical trials conducted from 2000 to 2021. Whereas private sector interest in cancer grew dramatically over this period, activity to combat bacterial infections remained stagnant.

2023 in review: FDA approvals of new medicines.

An analysis of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 69 new entities in the year 2023, 50 % more than in the previous year. Oncology drugs tied with congenital and infectious diseases drugs for the most approvals. Although orphan and priority approvals continued at a high pace, the rate of fast-track approvals continued to decline.

WANTED DEAD OR ALIVE: New Thinking to Incentivize Drug Development.

Despite unprecedented advancements in our understanding of disease process and targeting opportunities, our continued ability to discover and develop new medicines is fundamentally in doubt. These challenges reflect a growing recognition of the escalating risks of drug development (in terms of dollars and time) by established pharmaceutical companies and investors. Such hurdles are surmountable and require new thinking.

2022 in review: FDA approvals of new medicines.

An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals.

Immunoconjugates and bispecific antibodies: Trends in therapeutic success and commercial focus.

Monoclonal antibodies (mAbs) have revolutionized the selective targeting of disease, as well as changing the character of the pharmaceutical industry. Although most attention has focused on conventional antibodies, immunoconjugates and bispecific antibodies (bsAbs) are beginning to show greater potential. Herein, we identify trends in the development and approval of antibody derivatives, as well as the organizations developing these products.

Monoclonal antibodies: Trends in therapeutic success and commercial focus.

Monoclonal antibody products have risen from obscurity in the 1990s to a position that increasingly dominates both revenue generation and patient impact. This success has occurred largely over the past two decades, and we have identified factors associated with the remarkable advances that have contributed to the discovery, development and approval of monoclonal antibodies. Although consolidation has increased in recent years, the net number of monoclonal antibody developers continues to grow, bucking the general trend in the biopharmaceutical industry.

A Novel Innovation and Entrepreneurship (I&E) Training Program for Biomedical Research Trainees.

Problem: Contemporary science emphasizes efficient translation of scientific discoveries into tangible, innovative products and services to improve human health. Therefore, researchers need skills in innovation and entrepreneurship (I&E) to select which problems to address and bring to market the most promising solutions. Training in this skillset is not currently available to most biomedical research trainees.

2021 in review: FDA approvals of new medicines.

The year 2021 witnessed a remarkable number of US Food and Drug Administration (FDA) approvals and registered clinical trials. In total, 60 new molecular entities (NMEs) were approved by the FDA, the highest level achieved in the post-Prescription Drug User Fee (PDUFA) era and tied with 2018. Of these NMEs, 49 used the incentives of the Orphan Drug Act or were approved under Priority, Fast-Track, Accelerated, and/or Breakthrough designations.

Rising Academic Contributions to Drug Development: Evidence of Vigor or Trauma?

We analyzed therapeutic areas most commonly targeted by academia since 2001, finding a domination of certain oncology and infectious diseases. These findings raise important questions about whether this trend reflects an expanded opportunity arising from academic research or a troubling sign of an industry struggling with the challenges of innovation.

2020 in review: FDA approvals of new medicines.

Amid a global pandemic, the US Food and Drug Administration (FDA) remained relatively active, approving 55novel molecular entities (NMEs) in 2020, the third highest annual rate recorded. Orphan approvals also surged, capturing 60% of NMEs introduced during 2020, as did the number of NMEs approved using a priority review. The pandemic did appear to impact one recent trend, and in a paradoxically encouraging way.

Sources of innovation for new medicines: questions of sustainability.

The biopharmaceutical industry has undergone remarkable changes over the past half century, driven largely by a need to offset the ever-rising costs of developing new medicines. In this report, we aggregated information about the creation and fate of all clinical-stage biopharmaceutical companies, assessing trends over time. These results reveal that the rate of new company formation has been declining at the same time that industry consolidation has been accelerating at an unprecedented rate.

Oh, the Frustration of Antibodies!

The COVID-19 pandemic has been humbling for the biomedical community, pointing out as much about what we do not know as what we do. Among these learnings are lessons about immune-based measures to prevent or treat a new biothreat. This article summarizes lessons learned from two experimental approaches for passive immunity, convalescent plasma and monoclonal antibody therapy.

2019 in review: FDA approvals of new medicines.

The US Food and Drug Administration (FDA) green-lighted the marketing of 53 therapeutic agents in 2019. This rate of approvals was consistent with the 5-year running average. Nonetheless, a few changes are worth noting.

Expanding roles for academic entrepreneurship in drug discovery.

An assessment of inventors of US Food and Drug Administration (FDA)-approved medicines reveals a growing role for academic entrepreneurship in general and National Institutes of Health (NIH)-supported investigators in particular. For all small-molecule therapeutics approved between 2001 and 2019 (383 in total), 8.3% listed an academic inventor in the Orange Book.

CDEK: Clinical Drug Experience Knowledgebase.

The Clinical Drug Experience Knowledgebase (CDEK) is a database and web platform of active pharmaceutical ingredients with evidence of clinical testing as well as the organizations involved in their research and development. CDEK was curated by disambiguating intervention and organization names from ClinicalTrials.gov and cross-referencing these entries with other prominent drug databases.

2018 in review: FDA approvals of new molecular entities.

2018 was a remarkable year, both in terms of the number of new molecular entities (NMEs) approved and the organizations developing them. In total, 59 NMEs received a nod from the US Food and Drug Administration (FDA), most of which were approved using a priority or breakthrough designation. Orphan drugs accounted for more than half of new approvals, only the second time in history that level has been achieved.

Assessing the public landscape of clinical-stage pharmaceuticals through freely available online databases.

Several public databases have emerged over the past decade to enable chemo- and bio-informatics research in the field of drug development. To a naive observer, as well as many seasoned professionals, the differences among many drug databases are unclear. We assessed the availability of all pharmaceuticals with evidence of clinical testing (i.

Lost medicines: a longer view of the pharmaceutical industry with the potential to reinvigorate discovery.

It is widely understood that the 1962 Kefauver-Harris Amendment to the Food, Drug and Cosmetics Act ushered in the modern regulation of medicines requiring a combination of safety and efficacy. However, fewer appreciate the amendment was applied retroactively to virtually all medicines sold in the USA. For various reasons, many medicines faded into history.

2017 in review: FDA approvals of new molecular entities.

An overview of drugs approved by the FDA in 2017 reflected a reversion to the mean after a low number of NME approvals in 2016. This reversal was largely driven by the largest number of biologics-based NMEs recorded to date, which offset an average number of small-molecule approvals. Oncology indications continued to dominate followed by novel treatments for infectious, immunologic and neurologic diseases.

An overview of FDA-approved vaccines & their innovators.

A survey of FDA-approved biologicals focused upon the development of immunotherapies over time to gain insight on the challenges and trends of vaccine development today. Areas covered: A total of 135 different immune-based therapies were broadly divided into passive or active immunotherapies. Whereas just over half of passive immunotherapies targeted infectious diseases, the vast majority of active immunotherapy products (vaccines) were directed against a handful of viral and bacterial pathogens.