STAT

SEPTEMBER 3, 2024

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Drug Development 212

Drug Development 212

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance. Patel et al.

Drug Development 122

Drug Development Pharmaceutical Companies Pharmaceutical Companies Documentation 122

pharmaphorum

NOVEMBER 12, 2020

The company was founded as a spin-off of the University of Bern and Swiss research institute NCCR TransCure in April 2019, and is focused on the development of a new class of drugs that work on endocannabinoids, a type of neurotransmitter that bind to the receptors in the brain targeted by cannabinoid compounds. “In

Drug Development 106

Drug Development Compounding 106

pharmaphorum

JULY 19, 2022

Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.

Drug Development 105

Drug Development Communication 105

Express Pharma

APRIL 8, 2025

The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing. The division also incorporates international subsidiaries and acquisitionsAustria-based virus safety testing provider ViruSure (acquired in 2019), U.S.-based

Pharmaceutical Manufacturing 76

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Drug Development 76

Pharmaceutical Business Review

APRIL 24, 2024

The collaboration will explore various avenues to enhance the current platform technologies and introduce new drug candidates. OSR Holdings, which was established in 2019 in South Korea, operates on a “hub-and-spoke” business model, which is claimed to have gained prominence in the biopharma industry over the past decade.

Drug Development 59

Drug Development 59

BioPharma Dive

JUNE 21, 2024

A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.

Drug Development 65

Drug Development 65

Express Pharma

JUNE 11, 2024

With the evolving landscape of drug development and innovations, several institutes are serving as catalysts by partnering with pharmaceutical companies to drive progress at various stages of research and development. The number of clinical trials has significantly increased from 31 trials in 2019 to 79 trials in 2023.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies Drug Development Compounding 105

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

Drug Development 59

Drug Development 59

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. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. cited 2023Dec]. N Engl J Med.

Pharmaceutical Manufacturing 122

Pharmaceutical Manufacturing Drug Development 122

Pharmaceutical Business Review

JANUARY 10, 2024

“Our dedicated research and development efforts, supported by our Drug Studio AI platform, have focused on enhancing target selectivity and tissue targeting to minimize off-target effects, enabling the development of innovative and safer drugs.” It has two drug candidates in pipeline to provide pain relief.

Drug Development 95

Drug Development 95

pharmaphorum

JULY 21, 2021

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market.

Data Entry 105

Data Entry Drug Development Compounding 105

pharmaphorum

AUGUST 19, 2022

Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. The post Fuelling the efficiency of drug development through sensor data integration appeared first on.

Drug Development 52

Drug Development Documentation Hospitals 52

European Pharmaceutical Review

JANUARY 16, 2023

The drug is administered via intramuscular injection and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology. In 2019, there were 40 million individuals with bipolar disorder worldwide. The drug is part of Luye Pharmaceutical’s central nervous system (CNS) product portfolio.

Labelling 122

Labelling Drug Development 122

Pharmaceutical Technology

DECEMBER 6, 2022

HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. In the early stages of drug development, protecting operators from unknown risks is absolutely crucial.

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing Communication 52

pharmaphorum

FEBRUARY 11, 2022

” Hopes were high that a drug developed by Sangamo based on its zinc finger nuclease (ZFN) genome-editing technology could lead to the first therapy that could correct the genetic defect n MPS I, but that candidate – called SB-318 – flunked out in a clinical trial reported in 2019 and was discontinued.

Chemotherapy 111

Chemotherapy Drug Development 111

European Pharmaceutical Review

JANUARY 2, 2024

Pharma pushes for UK medicine scheme revision Drug pricing was considered as the most negative emerging regulatory and macroeconomic trend, impeding growth for the industry, based on GlobalData’s 2019, 2020, 2021, and 2022 industry outlooks.

Drug Pricing 102

Drug Pricing Drug Development 102

pharmaphorum

OCTOBER 29, 2020

Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The NICE-CADTH service was launched in 2019. What is the impact?

Documentation 101

Documentation Drug Development 101

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

JUNE 24, 2021

Lucentis has been approved by the FDA since 2006 for wet AMD and is a big earner for both Roche and Novartis, who share rights to the product with Roche selling the drug in the US and Novartis selling it in Europe and other markets. It launched in October 2019 in the US with sales predictions of $2.5

Diabetes 95

Diabetes Biosimilars Drug Development 95

pharmaphorum

FEBRUARY 1, 2021

Development of aducanumab has been far from straight forward. It was among the last of a batch of drugs developed by pharma companies over the last decade or so that target the amyloid plaques that are found in the brains of people with Alzheimer’s.

Drug Development 96

Drug Development 96

pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

Immunity 105

Immunity Immunization Drug Development 105

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. February 2019. There is a diminishing number of people available for caregiving and 1 in 6 adults expects to become a caregiver within 2 years.

Labelling 98

Labelling Drug Development 98

Pharma Mirror

JANUARY 24, 2023

Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development. billion by 2026, up from $186 billion in 2019 according to the Evaluate Pharma report.

Drug Development 52

Drug Development Diabetes 52

European Pharmaceutical Review

DECEMBER 21, 2022

What sponsors should know about psychedelic drug development. Although some psychedelics have a long history in traditional medicine, regulatory agencies must evaluate psychedelic compounds the same way they assess any other drug. Fast track designation. Accelerated approval. Psychedelic research: progress through collaboration.

Compounding 119

Compounding Drug Development Controlled Substances 119

pharmaphorum

OCTOBER 27, 2020

billion for the quarter, but reduced spending allowed operating profit to climb 9% compared to the same period of 2019, coming in at $2.4 The company also said that drug development is continuing with “manageable disruptions”, thanks to the use of digital technologies that are helping it to keep clinical trials running.

Drug Development 98

Drug Development 98

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

pharmaphorum

JANUARY 3, 2023

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019. ” The new data could accelerate partnering efforts of the drug this year.

Labelling 105

Labelling Drug Development 105

European Pharmaceutical Review

SEPTEMBER 14, 2023

There was a significant slowdown in drug development, clinical trials, and new drugs coming to market. EMA prepares for winter antibiotic shortages That slowdown resulted in 211 drug shortages in 2010—the highest number recorded in a single year at the time. 1 We can only learn from the past and try not to repeat history.

Drug Development 98

Drug Development Drug Pricing Communication 98

pharmaphorum

JUNE 8, 2021

All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. of the oncology market in China in 2019, compared to 17.1% Mei says that oncology is one of the key region-specific unmet medical needs Antengene is hoping to address with innovative drugs.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

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

Pharmaceutical Technology

NOVEMBER 2, 2022

According to the GlobalData’s Drug Database, the number of innovator small molecule approvals for rare diseases rose steadily over three years, from three approved in 2019 to 12 last year.

Drug Development 59

Drug Development 59

European Pharmaceutical Review

FEBRUARY 22, 2023

Parenteral delivery of oligonucleotide drugs All marketed oligonucleotide products are delivered as sterile preparations for parenteral delivery. The authors highlighted that there is a clear regulatory expectation that TS is the preferred method for sterilising parenteral products.

Communication 104

Communication Drug Development 104

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

AUGUST 17, 2022

Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.”. That same report noted that the number of companies in the AI drug discovery space increased tenfold between 2015 and 2021.

Compounding 97

Compounding Drug Development 97

European Pharmaceutical Review

AUGUST 17, 2022

The investigators found that the high burden of chronic and infectious diseases, growing focus on bioavailability enhancement for poorly soluble drugs, and the challenges associated with drug development were the major contributors to the demand for formulation development services globally.

Compounding 96

Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Development 96

Pharma Marketing Network

DECEMBER 9, 2020

This year revealed that pharma companies became more active investors in digital health – who made up 20% of digital health funding – an 11% increase from 2019. Several pharma companies are looking into AI and its capability to significantly cut the time and resources used to bring drugs to market.

Drug Development 59

Drug Development 59