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.

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RX Note

JULY 8, 2023

Introduction Drug development is an expensive and lengthy process , taking about 2-3 billion dollars and over 10 years to discover and develop a drug to commercialization. Drug Development Timeline Discovery and Development Research for a new drug begins in the laboratory.

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European Pharmaceutical Review

AUGUST 9, 2023

While injectable biologic therapies are an effective option for CSU that is uncontrolled by these drugs, less than 20 percent of patients worldwide are treated with them, according to a 2016 British Journal of Dermatology paper and research shared by Novartis.

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Express Pharma

MARCH 26, 2025

Japans Ministry of Health, Labor, and Welfare (MHLW) announced a new 10-year government fund in January 2025 to support innovative drug development. Australia and South Korea have similar government funds focussing on innovative drug development.

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pharmaphorum

SEPTEMBER 27, 2021

In addition, uncertainty is higher because historically some communities have shied away from using pharmaceutical products to treat their ailments – they have had their own cultural views on treatments and manufactured drugs have not necessarily been part of their lives. The same goes for filling quotas versus purposeful hiring.

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Pharmaceutical Technology

JULY 25, 2022

The drug developers will use artificial intelligence based on the acquired data from these devices and from the healthcare providers, allowing them to create and provide personalized treatments maybe even in predictive ways later on,” he explains.

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Pharmaceutical Technology

MARCH 29, 2024

Vemlidy was first approved to treat adults with HBV in 2016. Its label was expanded in 2022 for use in patients 12 years and older.

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pharmaphorum

JANUARY 29, 2021

They wanted someone who had lots of experience in drug development, was a molecular biologist, and was stubborn enough to take on CRISPR!” When I started in 2016 it was still a very academic field without much industrial interest. billion in funding. It’s just a matter of getting the field there.”. About the interviewee.

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pharmaphorum

MARCH 29, 2021

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? At the end of the day, medicines are developed for patients, so understanding what they want and what they need remains absolutely crucial,” says Dr Catchpole.

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pharmaphorum

JUNE 28, 2021

Drug development is a costly endeavour, and without the expectations of a healthy return on investment, many developers have steered clear of the space. From 2016 to 2019, he was the chief business officer at miRagen therapeutics. This trend has had a significant impact on innovation over the last decade.

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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. In fact, one-quarter of rare disease trials between 2016 and 2020 were terminated due to low accrual rates.

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Drug Development 122

European Pharmaceutical Review

DECEMBER 14, 2023

Our research showed that in Europe between 1999 and 2016, 35 products were withdrawn. This may come as a surprise because RCTs are seen as the gold standard of drug development, and they certainly have their place. Meta-analyses contributed least frequently (31.4

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pharmaphorum

APRIL 27, 2021

In 2016, the agency was criticised by the US Government Accountability Office (GAO) for not gathering enough post-marketing data on drugs granted expedited approvals.

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Chemotherapy Documentation Drug Development 90

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author. 5): V38-V49.

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European Pharmaceutical Review

JULY 4, 2024

The second was crofelemer, Mytesi , an indicator drug for HIV-associated diarrhoea extracted from the blood-red latex of the South American croton tree. 2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

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pharmaphorum

NOVEMBER 6, 2020

She has been CIDO at Lilly since 2016, charged with leading the “digital transformation” of the company and merging a diverse portfolio spanning IT, information security, digital health, and data analytics. A search is now underway for her successor.

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Drug Development 56

European Pharmaceutical Review

OCTOBER 30, 2023

4 The pandemic highlighted the need to significantly shorten the overall vaccine development process, where mRNA vaccine technology was utilised for the first time in commercially available immunisations.

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Pharmaceutical Technology

MARCH 1, 2023

The FDA approval of Sarepta’s Exondys 51 to treat Duchenne muscular dystrophy (DMD) and the approval of Ionis’ Spinraza to treat spinal muscular atrophy (SMA) in 2016 marked critical milestones in the field, as the first ASO drugs to enter the market.

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Pharmaceutical Technology

AUGUST 26, 2022

The latest deal builds on an existing partnership entered by PathAI and BMS in 2016 and has provided results in various areas. This biomarker showed to potentially predict response to immunotherapy and aid in informing treatment decisions of the patient.

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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. O’ Neil, 2016. References. Robles Aguilar, A. Gray, et al.

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Drug Development Diabetes Chemotherapy 104

European Pharmaceutical Review

OCTOBER 19, 2022

26 April, 2016. The market impacts of pharmaceutical product patents in developing countries: The evidence from India. Biopharmaceutical Research & Development: The Process Behind New Medicines. Why 90% of clinical drug development fails and how to improve it? References. Cited 25 September 2022].

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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.

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Pharmaceutical Technology

JUNE 29, 2022

Almost 40 years since it was instituted, some have described the FDA’s orphan drug program, which is meant to foster innovation, as “ one of the most successful US legislative actions in recent history ”. Others judge its success based on the fact that 95% of rare diseases still have no available therapies and patient needs remain unmet.

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pharmaphorum

OCTOBER 14, 2020

Exscientia’s roster of partners – which also includes pharma heavyweights like Bayer, Bristol-Myers Squibb’s Celgene unit, Sanofi, GlaxoSmithKline, and Roche – have bought into the promise of its platform to accelerate drug discovery and improve drug development productivity.

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pharmaphorum

JUNE 25, 2021

But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In That to me is shocking.”. About the interviewee.

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Communication Drug Development 100

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.

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European Pharmaceutical Review

JULY 20, 2022

Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Known as pharmacovigilance, our epidemiological research records and investigates adverse drug reactions when medicines are used by the general public. Supporting regulators. Study focus.

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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. 1 (2016) 3. 8 (2018) 2. Hardoon and Susan E. Dennison, published in Journal of Business Research, Vol.

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pharmaphorum

OCTOBER 29, 2020

Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. OMA can offer a safe harbour for discussions with NICE, NHS commissioners and other stakeholders. This has proven popular too and has seen a steady increase in safe harbour meetings held over time (figure 2). Source: Data from NICE FOI responses. Great job!”.

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Documentation Drug Development 101

pharmaphorum

DECEMBER 2, 2022

Understanding how each stage of drug development ties together and how actionable data provides stakeholders with a closer look at protocol design and trial strategy analytics, we can predict the possible impacts in terms of cost, timelines, site, and patient experiences and more. 2016; 50(4):436-441; Tufts CSDD Impact Report.

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Pharma Marketing Network

MARCH 23, 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. 1 (2016) 3. 8 (2018) 2. Hardoon and Susan E. Dennison, published in Journal of Business Research, Vol.

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pharmaphorum

AUGUST 5, 2020

In a recent analysis of data from 2016 at the Queen Elizabeth Hospital Birmingham, 75% of unplanned admissions, which account for almost 30,000 admissions per year, were for older adults. Porkess adds that there are many other challenges in researching drugs that take into account multiple conditions.

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European Pharmaceutical Review

FEBRUARY 23, 2023

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

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pharmaphorum

SEPTEMBER 18, 2020

However, it withdrew its neuropharmacological drug, Zelmid, which was an SSRI, due to concerns over side effects only a year after it was introduced in 1982. In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide).

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pharmaphorum

JUNE 18, 2021

Patient recruitment and retention in clinical trials have long been significant challenges for drug developers. Four years before the pandemic, in 2016, Wout set up Deep 6 AI. Many clinical trials were halted or postponed, causing significant financial losses, stagnating innovation, and delaying patients receiving life?changing

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Medical Records Hospitals Drug Development 52

European Pharmaceutical Review

MARCH 8, 2023

She founded COMPASS Pathways with her husband George Goldsmith in 2016, having experienced at first hand the challenges in accessing evidence-based and effective mental health care for a family member. We started COMPASS after seeing so many people living with mental health conditions for which there is no good standard of care.

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Hospitals Drug Development 52

PharmaShots

MARCH 14, 2023

The article focuses on challenges faced in drug development, government incentive programs, grants, and various therapies used to diagnose or treat rare diseases. How challenging is the drug development plan Drug development plans for rare diseases can be circuitous, resulting in fewer participation from companies.

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