European Pharmaceutical Review

FEBRUARY 22, 2023

Small companies will need to either defer development or find a partner willing to fund the confirmatory Phase III programme. 5 Psychedelic research: evaluating the fast-evolving regulatory roadmap Experience of accelerated drug development The other impediment to accelerated development is an increased focus on “long-term patient outcomes”.

Drug Development 97

Drug Development 97

STAT

JUNE 4, 2023

The world has changed since 2018 when the Biotechnology Innovation Organization last brought its annual road show to Boston, complete with entrepreneurial boot camps, beer-flowing receptions, and four days of nonstop networking.

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Vaccines Drug Pricing Drug Development 254

pharmaphorum

FEBRUARY 10, 2021

The scheme aims to develop robust business models for the commercial exploitation of these technologies, with focused attention to all legal and ethical implications of such disruptive technologies. The post EU-funded project encourages use of simulation in drug development appeared first on.

Drug Development 76

Drug Development Packaging Documentation Hospitals 76

European Pharmaceutical Review

JANUARY 17, 2025

The National Institute of Health and Care Excellence (NICE) explained that HTA bodies assess evidence on the short-term effects of a drug provided by companies and drug developers. These surrogate endpoints (eg, biomarkers or intermediate outcome) are used to predict the long-term effectiveness of new treatments.

Drug Development 64

Drug Development 64

Pharmaceutical Technology

NOVEMBER 3, 2022

Emalex founder Jeff Aronin said: “Emalex was founded specifically to tackle serious neurological conditions like Tourette Syndrome, recognising that drug development for neurologic conditions is exceptionally difficult and few companies are willing to invest in bringing new options to these patients.

Drug Development 52

Drug Development Compounding 52

Express Pharma

APRIL 17, 2024

Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 GlobalData’s Pharma Intelligence Center Deals Database reveals that MASH drugs secured over $5.7

Drug Development 95

Drug Development Diabetes 95

European Pharmaceutical Review

MARCH 31, 2023

billion in total venture financing raised from 2010 to 2022 for drug development In 2018 alone, the company invested over $400 million in venture financing. This could open doors to greater biopharmaceutical and startup company collaborations in driving innovation for drug development,” Cartic concluded.

Drug Development 98

Drug Development 98

pharmaphorum

AUGUST 26, 2021

There are many benefits of including patients at every stage of the drug development process, as well as ways to involve them in the early stages of drug development. It helps to focus the drug development process on its main element – the patient, and it also makes good business sense, too.

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Drug Development Communication 105

Express Pharma

MARCH 30, 2023

billion in total venture financing raised from 2010 to 2022 for drug development. In 2018 alone, the company invested over $400 million in venture financing. According to GlobalData’s Pharma Intelligence Center Deals Database, SVB Financial Group and its subsidiaries were involved in over $1.4

Drug Development 95

Drug Development 95

European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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Compounding Drug Development 105

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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Drug Development Pharmaceutical Companies Pharmaceutical Companies 122

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. 2018; 22(5):1589-1604. 2018; 15(141):20170387. N Engl J Med. 2019; 380(14):1347-1358. Shickel B, Tighe PJ, Bihorac A, et al. 2015; 13:8-17.

Pharmaceutical Manufacturing 122

Pharmaceutical Manufacturing Drug Development 122

pharmaphorum

FEBRUARY 3, 2021

billion in 2018, according to the latest BioIndustry Association (BIA) and Clarivate report, and represents a 1,000% increase on 2012. BIA points to a sharp dip in the number of new biotechs formed in 2020 – just eight compared to 30 in 2019 and 47 in 2018 – suggesting that the pandemic had a dramatic impact on entrepreneurship.

Vaccines 111

Vaccines Drug Development 111

pharmaphorum

OCTOBER 31, 2022

Verge is one of a growing number of companies trying to tap into vast data sets to identify and develop patient response markers and hitherto unaddressed drug targets, with the aim of making drug discovery cheaper and more efficient. The post Verge Genomics takes AI-sourced drug for ALS into clinic appeared first on.

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Compounding Drug Development 136

European Pharmaceutical Review

FEBRUARY 21, 2023

After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. The exciting part for me is the ability to speed up drug development times, as well as unlock the true potential of this incredible plant. He founded Celadon in 2018.

Pharmaceutical Companies 132

Pharmaceutical Companies Pharmaceutical Companies Compounding Drug Development 132

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing 52

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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Drug Development Documentation 98

Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS)

Immunization 52

Immunization Immunity Drug Development 52

pharmaphorum

APRIL 27, 2021

On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

Express Pharma

MAY 22, 2023

The addition of India to this important study will help to accelerate the development of this drug,” said Mickey Mikitani, Co-CEO, Rakuten Medical. ASP-1929 is a conjugation of antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform.

Labelling 98

Labelling Drug Development 98

European Pharmaceutical Review

JUNE 5, 2023

Article: NDMA: a recall trigger for the drug development industry … The recent discovery of small-molecule nitrosamine impurities in marketed drugs, starting with N -nitrosodimethylamine (NDMA) in batches of Valsartan in 2018, has led to significant regulatory response, the paper noted. It was observed that 41.4

Drug Development 98

Drug Development Packaging 98

Pharmafile

MARCH 15, 2023

This funding marks the third grant awarded from the Bill & Melinda Gates Foundation to DelSiTech since 2018. This funding marks the third grant awarded from the Bill & Melinda Gates Foundation to DelSiTech since 2018. read more

Vaccines 40

Vaccines Drug Development 40

pharmaphorum

OCTOBER 5, 2022

billion deal in 2018. The new drug candidate for FSHD will combine an RNA molecule from miRecule targeting double homeobox 4 (DUX4) – a protein that is mutated in FSHD – with a nanobody developed by Sanofi that targets muscle cells.

Drug Development 105

Drug Development 105

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. 4,5 What is the key consideration drug developers should apply to gene therapies?

Drug Development 96

Drug Development Pharmaceutical Companies Pharmaceutical Companies Diabetes 96

pharmaphorum

APRIL 13, 2021

million users in the United States alone in 2018. million users in the United States alone in 2018” . She is an experienced executive in drug development and has over 30 years’ experience in the biotechnology and pharmaceutical industry. About the author. from September 2005 to August 2008.

Drug Development 111

Drug Development 111

FDA Law Blog: Biosimilars

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

pharmaphorum

OCTOBER 17, 2022

When James P Allison and Tasuku Honjo were awarded the Nobel Prize for Medicine in 2018 for their discovery of cancer therapy through inhibition of negative immune regulation, it shone a light on decades of research into recruiting the immune system to fight cancer. About the author.

Immunization 115

Immunization Immunity Drug Development 115

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.

Drug Development 59

Drug Development 59

pharmaphorum

AUGUST 31, 2021

However, like many other emerging healthcare technologies, they have been slow to gain traction and there is still confusion and scepticism around ECAs, stemming from a lack of precedence, step-by-step guidance and data to quantify their impact on drug development costs and clinical outcomes.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

Pharmacy Is Right For Me

AUGUST 10, 2022

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! Prior to my current role, I served as Scientific Director for Janssen Research and Development, leading two large Phase III trials and several Phase I studies.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 130

pharmaphorum

APRIL 19, 2021

With her patient engagement leadership and focus on incorporating patient voice throughout the drug development journey, I look forward to working with her.”. Peter Agathangelou, executive director of strategy and innovation at Prime Global, said, “I’m thrilled to welcome Emma!

Communication 59

Communication Drug Development 59

pharmaphorum

SEPTEMBER 11, 2020

In a recent analysis, the Tufts Center for the Study for Drug Development reported that more than two-thirds of all sponsors are using at least four different data sources. Their pool of 155 respondents comes from large pharma companies, biotech companies, device developers, and contract research organisations worldwide.

Data Entry 98

Data Entry Documentation Drug Development 98

pharmaphorum

JANUARY 25, 2022

In the past decade drug developers have doubled their R&D spend, but the number of drugs getting approved has stayed roughly the same, so the cost of bringing a new medicine to market has been rising. Revenue per drug has declined, and the result is that R&D returns have fallen by 80% since 2010, to 1.9%

Drug Development 52

Drug Development 52

European Pharmaceutical Review

MAY 20, 2024

As a result, enrolling patients in clinical trials is seen by pharmaceutical industry leaders as one of the biggest barriers to the development of potentially transformative medicines for rare diseases. Orphanet Journal of Rare Diseases (2018) 13:196. link] Rare-X. The Power of Being Counted Report.

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Drug Development 122

Pharmaceutical Technology

MAY 19, 2023

It received approval from the US Food and Drug Administration in October 2018. Yutiq is indicated to treat chronic, non-infectious uveitis that affects the posterior segment of the eye. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.

Diabetes 52

Diabetes Drug Development 52

Pharma Marketing Network

MAY 15, 2023

By analyzing data from electronic health records and other sources, companies can identify potential participants for clinical trials more quickly and easily, which can speed up the drug development process. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence. References 1.

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Pharmaceutical Companies Pharmaceutical Companies Drug Development 59

pharmaphorum

JANUARY 18, 2022

According to Rock Health’s annual digital health funding report, US-based digital health companies enabling life sciences research and development raised $5.8 This is the first time R&D has topped the chart since Rock Health began tracking US digital health funding in 2011, although it nabbed the number two slot in 2018 and 2020.

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Drug Development 91