Safe Biologics

SEPTEMBER 12, 2023

Drug Developer Discusses Impacts on R&D ​Steven Potts, PhD, MBA; CEO of Anticipate Bioscience is a cancer drug developer. Dr. Potts discussed how the IRA will reduce investment in drug research and development, particularly for small molecule drugs.

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Biosimilars Drug Pricing Drug Development 130

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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FDA Law Blog: Biosimilars

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. irritable bowel syndrome, primary biliary cholangitis).

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Drug Development 59

pharmaphorum

NOVEMBER 6, 2020

At the same time, the industry is looking to develop digital medicines that improve patient outcomes. That was followed by a stint in 2013 as global brand development leader in Lilly’s biomedicines business unit – leading up to the approval of Taltz (ixekizumab) for psoriasis – before making the step up to CIDO three years later.

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Drug Development 56

Express Pharma

NOVEMBER 1, 2024

In the marathon of drug development, where billions of dollars and over a decade of research are the norm, drug repurposing is quietly reshaping the landscape. Challenges in drug repurposing Despite these technological and regulatory advancements, the journey of drug repurposing is not without its challenges.

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pharmaphorum

JANUARY 17, 2023

Attrition in drug development for chronic disease is high, often because the wrong patients are selected for clinical trials,” Challis explained. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages. Dissecting heterogeneity.

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Drug Development 98

European Pharmaceutical Review

FEBRUARY 1, 2024

In this Q&A, he explores the trends and challenges within the cardiovascular treatment space, as well as clinical development of the company’s lead candidate obicetrapib, a cholesterol ester transfer protein (CETP) inhibitor for lowering low-density lipoprotein-cholesterol (LDL-C) and ultimately reducing cardiovascular risk.

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Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

OCTOBER 19, 2022

Biopharmaceutical Research & Development: The Process Behind New Medicines. Why 90% of clinical drug development fails and how to improve it? 23 April 2013. link] [Cited 25 September 2022]. Sun D, Gao W, Hu H, Zhou S. Acta Pharmaceutica Sinica B. 2022;12(7):3049-3062. CN202010111235.3A. 2020-02-24. 29(3), article 2.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

pharmaphorum

DECEMBER 7, 2022

Kalydeco was first assessed by the CT in May 2013 for treatment of cystic fibrosis patients of a minimum of six years old and carrying at least one G551D mutation in the CFTR gene, with an estimated eligible patient population of 80 and an ATC of approximately €235,000. The first and second articles in the series can be found here and here.

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Drug Pricing Drug Development 105

Safe Biologics

OCTOBER 10, 2023

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. – View clip. Clip 4: Panel Discussion – View clip.

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Biosimilars Drug Pricing Drug Development 130

pharmaphorum

AUGUST 5, 2020

“Secondly, this single-disease focus leads to polypharmacy, and we still don’t understand all of the drug-to-drug interactions that this older multimorbid patient will be experiencing and the impact on their health. Porkess adds that there are many other challenges in researching drugs that take into account multiple conditions.

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Hospitals Labelling Diabetes Drug Development 80

European Pharmaceutical Review

DECEMBER 26, 2023

Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5 He was named Head of Process Development in 2013, then promoted to Chief Scientific Officer (CSO) in 2020. million for Hemgenix [AAV5-hFIX-Padua]).

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Drug Pricing Packaging Vaccines Drug Development 98

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind. Since the FDA approved AstraZeneca’s monoclonal antibody therapy Synagis (palivizumab) 25 years ago, drug development successes for RSV have been few and far between.

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Vaccines Drug Development Pharmaceutical Companies Pharmaceutical Companies 64

European Pharmaceutical Review

JANUARY 16, 2023

Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey as the Senior Principal Scientist in early phase drug development. He consults in the areas of microbial risk assessment, regulatory affairs and microbiological testing.

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Vaccines Research Laboratories Documentation Compounding 128

PharmaShots

MAY 31, 2023

In addition, our ongoing digital health research highlights progress in developing advanced measurement methods that aim to enhance drug development and personalized care for better patient outcomes. Smriti: Shed some light on the details (MOA, ROA, formulation, etc.) of TECFIDERA (dimethyl fumarate).

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Vaccines Drug Development 40

STAT

AUGUST 24, 2023

  A new analysis of mid-year price hikes has found that, despite policy changes under the Inflation Reduction Act, drug prices are on the rise , STAT reports. The median price increase for these drugs was 3.4%, just above the one-year inflation rate of 3.2%.

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Putting Patients First Blog

SEPTEMBER 26, 2024

Further discussion on the unique aspects of rare disease drug development, the associated challenges, and when waivers may be warranted would greatly benefit all stakeholders, including sponsors, patient organizations, clinical researchers, and regulators. Journal of the American College of Cardiology , 71(18), 1960–1969. 9 Blehar, M.,

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Communication Clinical Pharmacology Documentation Drug Development 52

Safe Biologics

SEPTEMBER 11, 2023

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection.

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Drug Pricing Biosimilars Vaccines Drug Development 150

Pharmaceutical Technology

DECEMBER 13, 2022

Prominent SaaS systems were a huge inspiration, McVeigh says, but the technical challenge presented by the drug development world came with different demands. Ever since releasing the first generation of its IRT solution in 2013, Suvoda has been a leader in innovative, flexible clinical trial technology that is designed for the user.

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Communication Drug Development 104

Express Pharma

MARCH 25, 2025

The global central nervous system (CNS) market is projected to exceed $80 billion in sales in 2025 for the first time since 2013, making a significant resurgence after a decade of stagnation. Tokali concludes, Alzheimers remains one of the most complex areas of drug development, but recent approvals signal progress.

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Drug Development 99