European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 106

Food and Drug Administration Side effects Pharmaceutical Leads 106

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).

Healthcare 84

Healthcare Healthcare Electronics Safety 84

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen.

Management 85

Management Side effects Patients Safety 85

European Pharmaceutical Review

MARCH 10, 2023

Ocular suspensions and emulsions can deliver hydrophobic drugs, but may lead to blurred vision. Elements leading to a rational design of cyclodextrin-based formulations … Turning to innovative technology Looking to innovative technology solutions, nanotechnology-based carriers are gaining popularity, the review suggested.

Side effects 77

Side effects Management Leads Safety 77

Pharmaceutical Technology

NOVEMBER 14, 2022

Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson.

Side effects 144

Side effects Patients Manufacturing Safety 144

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). The company has already contacted funds based in Europe and in the US, said Buntinx.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

JANUARY 3, 2023

A pharmacologist by training, Rawlins was the founding chairman of health technology assessment (HTA) agency NICE , leading the organisation from its inception in 1999 until 2013, and hired Sir Andrew Dillon to become the organisation’s founding chief executive.

Side effects 52

Side effects Medicine Safety Healthcare 52

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B.

Patients 76

Patients Food and Drug Administration Side effects Food 76

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Internet] Available from: British Medical Association.

Safety 113

Safety Medicine Competition Networking 113

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. IgAN is the most common primary glomerulonephritis worldwide.

Food and Drug Administration 95

Food and Drug Administration Side effects Leads Patients 95

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. IgAN is the most common primary glomerulonephritis worldwide.

Food and Drug Administration 94

Food and Drug Administration Side effects Leads Patients 94

Pharmaceutical Technology

MARCH 7, 2023

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The Visionary trial has exclusively enrolled MS patients with chronic optic neuropathy, in which progression of MS leads to damage of the optic nerve. before the submission to the FDA.

Side effects 100

Side effects Patients Leads Safety 100

Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma companies need tools like AI that can reliably improve this percentage without jeopardizing safety. The need for new medical treatments and drugs has never been greater.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

Pharmaceutical Technology

DECEMBER 16, 2022

Kissei Pharmaceutical’s GnRH antagonist, Yselty (linzagolix), will be another important driver of growth during the forecast period. GnRH antagonists have an improved safety and efficacy profile compared to the marketed GnRH agonists, which have significant side effects that are unappealing to patients.

Marketing 59

Marketing Side effects Sales Safety 59

PM360

MAY 25, 2023

This is different from clinical trials which are really designed to look at efficacy and safety in a very controlled environment, so controlled trials are very good at answering those two questions. They’re wonderful medications, blockbuster sales, but real side effects. Do they have any side effects associated with them?

Side effects 95

Side effects Medical Patients Networking 95

European Pharmaceutical Review

MARCH 24, 2023

In NASH, excess fat in the liver can lead to progressive disease, including inflammation, liver cell injury and fibrosis, which are associated with increased risk for cardiovascular disease and liver morbidity and mortality. Pegozafermin also has a favourable safety and tolerability profile, with few gastrointestinal (GI) side effects.

Medical 85

Medical Side effects Safety Pharmaceutical 85

Quantified

MAY 2, 2024

Pharmaceutical sales opportunities are notoriously high stakes. They also need to know which conditions each medication treats and accurately convey their therapeutic benefits, safety profiles, possible side effects, and the most recent data available related to patient outcomes. That’s a lot of information.

Training 52

Training Sales Pharma Sales Management 52

Pharmaceutical Technology

JUNE 15, 2023

Developing safe and effective drugs Pharma researchers are using AI in the earliest stages. They’re also deploying AI to predict how new drugs will interact with the human body — and what side effects might arise. AI’s ability to analyze data quickly also contributes to safety, including during clinical trials.

Healthcare 52

Healthcare Healthcare Safety Ethics 52

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

Networking 59

Networking Consulting Safety Side effects 59

European Pharmaceutical Review

JULY 5, 2022

There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. Irinotecan – also known by the brand name Campto/Camptosar ® (Pfizer Ltd.) – has proven to be an effective chemotherapy agent against several types of gastrointestinal cancer.

Patients 85

Patients Food and Drug Administration Side effects Safety 85

Medico Reach

FEBRUARY 8, 2023

The pharmaceutical sector has witnessed a steep growth in recent times. With the use of trailblazing digital platforms, cost-effective technologies, big data analytics, blockchain, and artificial intelligence (AI), the landscape is undergoing a massive transition. The global pharmaceutical manufacturing market stood at USD 405.52

Pharma 52

Pharma Medicine Marketing Prospecting 52

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. The post The evolution of AAVs in cell and gene therapy appeared first on European Pharmaceutical Review.

Consulting 60

Consulting Side effects Manufacturing Safety 60

Pharmaceutical Technology

JANUARY 25, 2023

By selectively degrading these proteins, PROTACs have the potential to effectively treat a range of diseases with potentially fewer side effects compared to traditional approaches. The post PROTACs show promise for cancer treatment appeared first on Pharmaceutical Technology.

Side effects 52

Side effects Leads Safety Manufacturing 52

Contrarian Sales Techniques

DECEMBER 4, 2023

In the bustling world of pharmaceutical sales, the role of a sample bag is often understated yet crucial. Imagine this: a pharmaceutical sales representative, armed with the latest and greatest in medical advancements, sets out to make their mark in the competitive healthcare industry. A chaotic bag can lead to a chaotic presentation.

Sales 52

Sales Pharmaceutical Sales Pharma Ethics 52

PM360

AUGUST 9, 2022

Accordingly, multiple reasons for subpar patient adherence are gaining attention, including fear of side effects, lack of medical understanding, or even financial limitations. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

Medical 105

Medical Electronics Patients Healthcare 105

PM360

JULY 13, 2023

Based upon years of client demand from Inizio Engage and its enriched Trak360 technology platform, Patient Access offers an expanded suite of services: Treatment Navigators who provide supplemental education on the disease, its treatment, possible side effects, and address patient concerns on the road ahead.

Education 89

Education Medical Media Patients 89

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study.

Food and Drug Administration 110

Food and Drug Administration Patients Side effects Safety 110

Pharmaceutical Technology

NOVEMBER 23, 2022

The trial is designed to analyse the safety and efficacy of Hemgenix. The mean adjusted annualised bleeding rate (ABR) for all bleeds declined by 54% in the seven to 18 months following infusion versus the six-month lead-in period on factor IX prophylactic replacement therapy.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 79

Food and Drug Administration Safety Patients Leads 79

European Pharmaceutical Review

JUNE 16, 2023

With the adoption of digital technologies gaining traction in many industries, pharmaceutical companies must take advantage of digitalisation within its research and development (R&D) sector. This can lead to faster access to information, reduce the need for large cohorts and therefore an acceleration in progress in medical research.

Safety 103

Safety Electronics Recruitment Medical 103

European Pharmaceutical Review

AUGUST 14, 2023

Swedish pharmaceutical company Vicore Pharma is developing treatments for diseases where the angiotensin II type 2 receptor (AT2R) has a central role in stopping and reversing disease pathology and where there is a large unmet medical need. The company’s lead candidate, C21, is an angiotensin II type 2 receptor agonist (ATRAG).

Pharma 90

Pharma Side effects Patients Manufacturing 90

Pharmaceutical Technology

JANUARY 24, 2023

NGN-401 showed robust therapeutic and safety benefits while delivering MECP2 to important regions of the brain that are affected by Rett syndrome in a comprehensive preclinical programme. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

FDA 83

FDA Food and Drug Administration Side effects Safety 83

pharmaphorum

SEPTEMBER 28, 2022

Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, side effects, and cost-effectiveness, among other factors. The implementation of the resulting recommendations can reduce payer uncertainty and lead to optimized HTA submissions.

Biopharma 52

Biopharma Side effects Consulting Pharmaceutical products 52

PM360

NOVEMBER 29, 2022

Researchers are diligently creating new methods for cell and gene editing as well as therapeutic delivery to increase safety, accessibility, and affordability. The advanced therapy industry has shown great promise in treating rare and genetic diseases, but have encountered roadblocks in safety, affordability, and accessibility.

Patients 111

Patients Safety Marketing Side effects 111

European Pharmaceutical Review

DECEMBER 27, 2023

In other words, the apheresis centres must become an integral part of the pharmaceutical production line with identical quality assurance and regulations, which is new and unpreceded for both sides. On the logistics side, the in-house process eliminates, in principle, the need for cryopreservation of the CAR T-cell products.

Manufacturing 85

Manufacturing Food and Drug Administration Patients Pharma 85

World of DTC Marketing

SEPTEMBER 28, 2020

Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing? Under NO circumstances should any pharmaceutical product be allowed into the market without complete and thorough testing. OK, NOW WHAT? J&J received more than $1 billion from the U.S.

Food and Drug Administration 163

Food and Drug Administration Pharma Side effects Food 163

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. What is drug dose optimisation?

FDA 115

FDA Side effects Pharmacology Patients 115