European Pharmaceutical Review

NOVEMBER 5, 2024

According to Medincell, TEV-‘749 could be the first long-acting olanzapine medication with a favourable safety profile, because “other LAIs of olanzapine have been associated with a [US] FDA black box warning for PDSS that limits their use”. This was based on findings from the initial period (up to week 8) of the Phase III SOLARIS trial.

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Side effects Safety Medical Medicine 52

MedCity News

JANUARY 30, 2024

With the rise of AI technologies, we could see significant advancements in cancer treatment, making it more efficient and potentially leading to a cure. By analyzing vast amounts of data from medical records, laboratory tests and imaging scans, AI algorithms can provide a more precise diagnosis, which can lead to better treatment outcomes.

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Side effects Ethics Medical Patients 123

European Pharmaceutical Review

MARCH 8, 2023

If the orally-delivered drug is confirmed have similar in safety and efficiency as the injectable forms, researchers stated that a PCSK9 inhibitor in a pill form could lower costs, increase convenience and expand patient access to the treatment. This is a highly effective compound that was well tolerated,” stated Dr Christie M.

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Side effects Safety Medicine Patients 98

European Pharmaceutical Review

SEPTEMBER 20, 2022

This interchangeability refers to the fact that a reference medicine can be substituted by a biosimilar, without risk, side effects or outcomes different to the original drug. Analytical evidence by the EMA indicated that there was a lack of safety concerns regarding approval of biosimilars compared with their reference medicines.

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Medicine Side effects Safety Doctors 98

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.

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Food and Drug Administration Patients Side effects Safety 116

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

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Side effects Safety Biopharma Recruitment 98

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.

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Food and Drug Administration FDA Side effects Food 105

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.

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Side effects Management Leads Safety 101

World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. The major concerns for hesitancy included worries over side effects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness.

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Food and Drug Administration Government Safety Manufacturing 203

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.

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Management Side effects Patients Safety 100

pharmaphorum

AUGUST 8, 2022

Karuna Therapeutics has unveiled positive topline results from its phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia.

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Side effects Leads Medical Safety 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.

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Patients Food and Drug Administration Side effects Food 96

European Pharmaceutical Review

JUNE 16, 2023

By incorporating a more comprehensive range of individuals in clinical trials, researchers can obtain valuable insights into the efficacy and safety of drugs across various populations. This can lead to faster access to information, reduce the need for large cohorts and therefore an acceleration in progress in medical research.

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Safety Electronics Recruitment Patients 111

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.

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Side effects Patients Manufacturing Safety 144

Pharma Leaders

MAY 18, 2023

The regulatory agency has determined that the NDA is a class 2 review , which leads to a six-month review period from the date of resubmission. Diarrhea was the most common side effect with XPHOZAH. It has set a user fee goal date of 17 October this year.

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Food and Drug Administration FDA Side effects Prospecting 52

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). Due to this, adjunctive treatments are used as part of a patient’s treatment regimen.

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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.

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Side effects Medicine Safety Healthcare 52

Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales.

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Marketing Pharmaceutical Sales Education 98

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. The transgene regulation technology can be tuned to provide a desired transgene expression level in a narrow range.

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FDA Food and Drug Administration Side effects Safety 83

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.”

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Food and Drug Administration Side effects Pharmaceutical Leads 115

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).

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Healthcare Healthcare Safety Electronics 98

PM360

OCTOBER 22, 2024

A treatment’s impact on utilization of other healthcare services: The effects of a treatment can lead to changes in the utilization of other healthcare products and services, such as hospitalizations, surgeries, or use of other drugs.

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Side effects Patients Prescription Healthcare 52

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.

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Medicine Safety Competition Networking 116

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. The study included 92 adult patients with confirmed CDI.

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Safety Patients Side effects Healthcare 111

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?

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Side effects Medical Patients Networking 95

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.

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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.

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Food and Drug Administration Side effects Recruitment Safety 52

pharmaphorum

JULY 7, 2022

New data on Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD) has gone a long way towards building confidence in its efficacy – but have introduced a concern about its safety. In the case of Pfizer’s candidate, that clinical hold occurred after cases of myocarditis were seen that have been linked to the gene therapy.

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Safety Side effects FDA Patients 59

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.

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Food and Drug Administration Patients Leads Side effects 98

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.

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Food and Drug Administration Patients Leads Side effects 98

pharmaphorum

SEPTEMBER 11, 2022

Hard on the heels of a new $575 million partnership with GSK, US biotech SpringWorks Therapeutics has reported phase 3 data at ESMO that sets up regulatory filings for its lead drug nirogacestat in a rare and aggressive form of soft tissue cancer.

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Side effects Leads Safety Patients 52

Clarivate

MAY 1, 2024

However, the high cost associated with the drugs, along with spotty reimbursement and side effects, could prompt some patients to reconsider a surgical approach whose safety and efficacy are well understood. Device-based treatments for comorbidities associated with obesity will also see an impact.

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Side effects Physicians Medical Patients 59

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.

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Biopharma Side effects Consulting Pharmaceutical products 52

Pharmaceutical Technology

DECEMBER 16, 2022

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. Kissei Pharmaceutical’s GnRH antagonist, Yselty (linzagolix), will be another important driver of growth during the forecast period.

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Marketing Side effects Sales Safety 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.

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Patients Food and Drug Administration Side effects Safety 104

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.

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Healthcare Healthcare Safety Ethics 52

pharmaphorum

OCTOBER 10, 2022

Pertussis is a highly contagious respiratory disease that can affect all age groups and lead to serious health complications and even death in infants. According to the Centers for Disease Control and Prevention (CDC), last year 4.2% of total cases of whooping cough reported in the US were in infants younger than six months old.

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FDA Side effects Safety Sales 52