European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. The worldwide trend of using botanical drugs and strategies for developing global drugs.

Drug Development

Syner-G

APRIL 27, 2023

Once a drug or biologic has been granted orphan drug status, Sponsors may be eligible to receive benefits such as tax credits for some of their clinical trials or qualified clinical testing costs, a waiver of the prescription drug user application fee, and may be eligible for seven years of marketing exclusivity upon product approval.

Drug Development

pharmaphorum

DECEMBER 6, 2022

Iddo Peleg (CEO, and one of the four co-founders of YonaLink) and Gav Martell (co-founder and vice president of business development) discussed how a recent $6 million funding round led by Debiopharm Innovation Fund will support their mission to transform clinical trials and bring lifesaving therapies to market faster.

Data Entry

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Now, we know better.

Packaging

Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). The EU previously focused on AMR through the One Health Action Plan, which was released in 2017.

Drug Development

PharmaShots

JUNE 14, 2023

Diagnostic Revenue: $4.60B Founded Year: 1934 Total Employees: ~75,470 Headquarters: Tokyo, Japan Market Cap: $26.32B Stock Exchange: TYO Fujifilm Medical is a renowned name in the diagnostic business that develops and delivers diagnostic imaging products and medical informatics.

Hospitals

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

Documentation

Express Pharma

AUGUST 10, 2024

Divergent regulatory requirements between NDCTR 2019 and Medical Device Rules 2017; between NDCTR 2019 and biologics guidelines; and the need for animal studies for approved new drugs with modified or new claims would make the regulatory process time-consuming and costly for a startup.

Drug Development

PharmaTech

JUNE 23, 2025

Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs. It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties.

Compounding

pharmaphorum

JANUARY 18, 2022

Training device developers. Drug developers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. POST CONFERENCE WORKSHOP B: Developing User-Centric Next Generation Combination Products.

Packaging

FDA Law Blog: Biosimilars

JUNE 9, 2025

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in 2012, directed FDA to investigate how well demographic subgroups (sex, age, race and ethnicity) were included in clinical trials to support approval of applications for medical products and whether subgroup-specific safety and effectiveness data were available.

Documentation

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said. But who is benefitting?

Vaccines

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., Patient and public perspectives on cell and gene therapies: a systematic review. and Kumar, P.

Communication

Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Exclusion of pregnant women from industry-sponsored clinical trials.

Communication