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.

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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

Pharmaceutical Technology

DECEMBER 16, 2022

As per the WHO’s 2022 malaria report , 63,000 malaria deaths were attributed to Covid-19-caused disruptions to services from 2019–21. The post 2022 in review: Drug development milestones for tropical diseases appeared first on Pharmaceutical Technology.

Drug Development 105

Drug Development Vaccines Clinical Pharmacology Compounding 105

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.

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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

pharmaphorum

AUGUST 8, 2022

GBT won FDA approval for Oxbryta (voxelotor) as a daily tablet for the treatment of SCD in patients aged 12 and over in 2019, extending its use to include younger children aged four and over last December, and earlier this year also got a green light from regulators in Europe for the over 12s. billion takeover bid for Biohaven.

Drug Development 52

Drug Development Vaccines 52

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

Express Pharma

AUGUST 10, 2024

The regulatory system is based on New Drugs and Clinical Trials Rules (NDCTR) 2019, guidelines, processes, checklists, and review by advisory committees. Bio-entrepreneurs are interested in developing a diversity of new healthcare products based on new sources, new targets or new formulations.

Drug Development 105

Drug Development Vaccines Dosage Documentation 105

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

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

FEBRUARY 3, 2021

billion in 2019. 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. billion ($3.8 billion) from a level of £1.3 Fewer companies founded. Not all the data points are positive.

Vaccines 111

Vaccines Drug Development 111

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.

Immunization 105

Immunization Immunity 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

pharmaphorum

JUNE 9, 2022

In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products. Centers for Disease Control and Prevention 2019. Blood 2019 Vol.

Drug Development 104

Drug Development Diabetes Chemotherapy 104

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.

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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

NOVEMBER 1, 2023

He is an experienced biotech and technology industry executive with international experience in drug development, data science, sales and marketing, and business management. Bacterial vaccines in clinical and preclinical development 2021 [Internet]. 2019 Jan; 7(1): e58-e67. 2019 Oct 16;7(4):151. The Lancet.

Vaccines 115

Vaccines Immunity Immunization Drug Development 115

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

Pharmacy Is Right For Me

MAY 1, 2023

So, whether it’s research and drug development, consulting, analytics, government service, or economics, pharmacists are using their skills in a multitude of ways. Pharmacists have the opportunity to specialize in fields like pediatrics, cardiology, oncology, geriatrics, and psychiatry. They each perform many different functions.

Community Pharmacies 130

Community Pharmacies Hospitals Vaccines Drug Development 130

pharmaphorum

MARCH 22, 2021

Baselga was a heavyweight in oncology research, pursuing a career that saw him serve as physician-in-chief at Memorial Sloan Kettering Cancer Centre in the US and also hold the position as president of the American Association of Cancer Research (AACR) before joining AZ to lead the drugmaker’s cancer R&D in January 2019.

Drug Development 111

Drug Development 111

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

STAT

MARCH 6, 2023

Determined to prove his doctors wrong, Aldrich got his tumor genetically sequenced and arranged for a German biotech, CeGaT, to design an experimental neoantigen vaccine that he received in 2019, according to Jacobs and an account Aldrich gave to an online cancer publication.

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Vaccines Bioethics Immunity Immunization 246