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.

Medicine 92

Medicine Side effects Safety Doctors 92

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.

Side effects 79

Side effects Safety Biopharma Recruitment 79

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.

Food and Drug Administration 203

Food and Drug Administration Government Safety Side effects 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.

Management 73

Management Side effects Patients Safety 73

Legacy MEDSearch

DECEMBER 12, 2022

Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine. .

Side effects 98

Side effects Insurance FDA Pharmacology 98

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

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.

Side effects 52

Side effects Leads Safety Medical 52

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

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

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.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 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.

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

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

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.

Marketing 98

Marketing Pharmaceutical Sales Education 98

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.”

Food and Drug Administration 107

Food and Drug Administration Side effects Pharmaceutical Leads 107

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 85

Healthcare Healthcare Electronics Safety 85

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

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

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

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

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.

Safety 59

Safety Side effects FDA Patients 59

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.

Side effects 52

Side effects Leads Safety Patients 52

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.

Side effects 52

Side effects Recruitment Networking Management 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.

Marketing 59

Marketing Side effects Sales Safety 59

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

pharmaphorum

AUGUST 11, 2022

Next, pharmacists review the participant’s genetic results – along with health data such as drug, lifestyle, and food interactions – to customize a “Medication Action Plan” that members’ physicians can access to determine which drugs should be prescribed to increase safety and efficacy.

Side effects 82

Side effects Medical Prescription Patients 82

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 86

Patients Food and Drug Administration Side effects Safety 86

Legacy MEDSearch

JUNE 28, 2023

1 Early treatment of PWS during childhood leads to the best clinical response. 1 Early treatment of PWS during childhood leads to the best clinical response. 3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects.

Medical 52

Medical FDA Recruitment Side effects 52

pharmaphorum

AUGUST 2, 2022

There was a slower than expected decline in the placebo group in the trial, which enrolled people with autosomal dominant Alzheimer’s disease (ADAD) associated with the Presenilin 1 E280A mutation, which leads to cognitive impairment in the mid-40s.

Side effects 52

Side effects Safety Patients Leads 52

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 86

Medical Side effects Safety Pharmaceutical 86

pharmaphorum

JANUARY 13, 2023

The new draft guidance introduces some flexibility into the assessments that doctors currently use to decide whether a statin should be prescribed, based on new data reinforcing the safety of the widely-used drug class, which are known to reduce the risk of cardiovascular disease when used for primary prevention.

Side effects 52

Side effects Patients Doctors Medical 52

pharmaphorum

JULY 26, 2022

Merck’s exit came after other companies including Pfizer, Eli Lilly and Roche all scrapped CETP development programmes following safety or efficacy issues. Others were let down not by safety but efficacy, with anacetrapib coming closest to showing value in a phase 3 trial.

Side effects 52

Side effects Safety Pharma Patients 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. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.

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. According to Syngene: “Although PROTACs are considered revolutionary, to date, the design and optimization of PROTACs remain empirical.

Side effects 52

Side effects Leads Safety Manufacturing 52

Medico Reach

FEBRUARY 8, 2023

AI can lead to faster research, combining and extracting data into usable formats, making clinical trials more efficient and saving time. The Emergence of the Pharmacovigilance Market Medicines and vaccines often have unwanted and severe side effects. The global pharmacovigilance (PV) market stood at USD 7.80 from 2023 to 2030.

Pharma 52

Pharma Medicine Marketing Prospecting 52