European Pharmaceutical Review

JUNE 24, 2022

But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.

Compounding 105

Compounding Drug Development Drug Pricing Dosage 105

Syner-G

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Category: Regulatory Affairs , Drug Development Consulting.

Documentation 52

Documentation Drug Development Communication 52

Pharmaceutical Technology

MAY 3, 2023

Originally marketed as Lyrica by Viatris, a combination of Mylan and Pfizer’s division Upjohn, generic versions of the drug became available in 2019. Barriers to access post-approval After the FDA approves a branded or generic drug, the application holder makes the ultimate decision as to when to market the product.

Generic Medicine 98

Generic Medicine Drug Development Communication Diabetes 98

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. The UK and US are both undergoing an obesity crisis. were overweight but not obese.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

MAY 30, 2023

The company believes this approach has the potential to revolutionise drug discovery in therapeutic areas with unclear mechanisms or limited success using traditional methods. AI has already proven a boon in other areas of drug development in recent years with the Covid-19 pandemic motivating innovation.

Communication 84

Communication Drug Development 84

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. The UK and US are both undergoing an obesity crisis. were overweight but not obese.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Pharmaceutical Technology

MAY 30, 2023

The company believes this approach has the potential to revolutionise drug discovery in therapeutic areas with unclear mechanisms or limited success using traditional methods. AI has already proven a boon in other areas of drug development in recent years with the Covid-19 pandemic motivating innovation.

Communication 52

Communication Drug Development 52

Pharmaceutical Technology

MARCH 23, 2023

Scientific research and a better understanding of the condition is driving new developments in medications. The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says.

Communication 52

Communication Drug Development 52

Putting Patients First Blog

APRIL 30, 2024

This method not only prioritizes the participant’s comprehension but also aligns with best practices in health communication that suggests a focused approach can significantly enhance understanding and retention of important information. The importance of using plain language in health communications is well-documented in literature.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52

pharmaphorum

APRIL 11, 2022

Delivering value for patients doesn’t start and end in our R&D labs; actions can be implemented across all stages of the drug development lifecycle to encourage and embrace a pro-innovation environment. Between 2016-2019, she was the medical affairs therapeutic area lead in haematology for Janssen Oncology across the EMEA region.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. Translational Medicine Communications, 4(18). Comparison of research spending on new drug approvals by the National Institutes of Health vs the pharmaceutical industry, 2010-2019. Newsome, P.,

Communication 40

Communication Documentation Drug Development 40

pharmaphorum

SEPTEMBER 9, 2021

Public health agencies and pharma pivoted in countless ways, from decentralising clinical trials and accelerating research and development, to enabling remote care and remote working with rapid digitisation. And we transformed so quickly because the key players communicated and collaborated.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

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. I still feel that it is very important,” Dr Mullen said. “We’ve

Vaccines 111

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 111

Putting Patients First Blog

SEPTEMBER 26, 2024

This includes being aware of historical injustices that may have contributed to mistrust in the medical system and understanding the unique needs and concerns of different communities. Effective communication with diverse populations is essential for ensuring that all individuals can participate in clinical trials. Williams, S.,

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. Several drug development trends are driving injectables demand.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

Drug Patent Watch

DECEMBER 11, 2024

In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. 2019, March 6).

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Communication Drug Development 98

Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. This may sound obvious, but it is still a major hurdle in drug development.

Vaccines 52

Vaccines Communication Immunity Immunization 52

PharmaShots

APRIL 3, 2023

The system offers alternative options for those patients receiving other medications The system was originally approved in 2019 for treating chronic pain. vs 10%) The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

Drug Patent Watch

DECEMBER 18, 2024

According to a 2021 study by the Tufts Center for the Study of Drug Development, the average cost to develop a new drug is a staggering $2.6 A robust patent strategy often involves filing multiple applications at different stages of drug development. billion[1].

Drug Development 98

Drug Development Compounding Dosage Pharmaceutical Companies 98