European Pharmaceutical Review

APRIL 5, 2024

These interim data indicate early signs of potential clinical benefit with mRNA-3927, and importantly also demonstrate that mRNA-3927 has infrequent treatment-limiting side effects. As of the latest data cut off at the end of May 2023, over 15 person-years of the therapy were administered.

Side effects 90

Side effects Safety Patients Leads 90

World of DTC Marketing

JULY 21, 2021

Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.”

Marketing 285

Marketing Prescription Side effects Doctors 285

Pharmaceutical Technology

NOVEMBER 30, 2022

While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. Currently, only Roche’s Ocrevus (ocrelizumab) is available for this patient population and its efficacy is limited.

Patients 98

Patients Side effects Safety Pharmaceutical 98

European Pharmaceutical Review

OCTOBER 31, 2022

The Pharmacovigilance Risk Assessment Committee (PRAC) , the European Medicines Agency (EMA)’s safety board, has confirmed it recommends the withdrawal of Marketing Authorisation Application (MAA) for amfepramone obesity medicines, to prevent more patients being at risk of serious side effects. Risks of amfepramones.

Side effects 84

Side effects Medicine Safety Marketing 84

European Pharmaceutical Review

MARCH 25, 2024

“Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mortality,” said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine, Anti-Infectives and Hospital, Pfizer. “If

Side effects 94

Side effects Medicine Safety Patients 94

European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. Data that facilitated the line extension of Comirnaty ® for Covid-19.

Food and Drug Administration 85

Food and Drug Administration Patients Side effects Medicine 85

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

Patients 76

Patients Food and Drug Administration Side effects Food 76

Pharmatutor

JANUARY 23, 2023

Pharmacovigilance - Indian view of 2023 admin Tue, 01/24/2023 - 12:26 Pharmacovigilance is the process of monitoring and assessing the safety of medications after they have been approved and are on the market.

Side effects 52

Side effects Safety Medical Marketing 52

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. Side effects from treatment were similar to those associated with autologous stem cell transplants.

Safety 96

Safety Side effects Medicine Patients 96

European Pharmaceutical Review

OCTOBER 9, 2023

A new drug, part of a class of chemicals called potassium-channel openers, has demonstrated potential in offering relief to patients with focal epilepsy. Comparatively, patients given a placebo had on average 18 percent fewer seizures during the treatment phase of the trial, which lasted eight weeks.

Side effects 95

Side effects Recruitment Safety Medicine 95

MedCity News

JANUARY 30, 2024

By catching the disease early, patients have a higher chance of receiving successful treatment, and the cost of treatment can be significantly reduced. Personalized treatment plans: Treatment plans can vary widely depending on the type of cancer, the stage and the patient’s overall health.

Side effects 126

Side effects Ethics Medical Patients 126

European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

Food and Drug Administration 95

Food and Drug Administration Side effects Safety Food 95

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. New hope for stomach cancer patients.

Patients 85

Patients Food and Drug Administration Side effects Safety 85

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Side effects 64

Side effects Food and Drug Administration Safety Physicians 64

European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Food and Drug Administration 90

Food and Drug Administration FDA Side effects Safety 90

European Pharmaceutical Review

NOVEMBER 1, 2022

The committee advises that Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib), used for chronic inflammatory conditions, should have limited distribution to minimise risk of serious side effects such as cardiovascular diseases, blood clots, cancer and serious infections.

Side effects 89

Side effects Distribution Safety Patients 89

European Pharmaceutical Review

NOVEMBER 18, 2022

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. Upstaza is administered through a minimally invasive neurosurgical stereotactic procedure used to treat several neurological disorders in paediatric and adult patients. Upstaza clinical trials.

Side effects 126

Side effects Biopharma Safety Patients 126

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. Clinically, it is common practice for doctors to rotate patients between different biologics.

Medicine 91

Medicine Side effects Safety Doctors 91

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

European Pharmaceutical Review

NOVEMBER 18, 2022

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” remarked Dr John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. Patients randomly received Tzield or placebo.

Food and Drug Administration 94

Food and Drug Administration FDA Side effects Food 94

Clarivate

MAY 1, 2024

GLP-1s will offer an attractive option to patients hesitant to undergo an invasive surgical procedure, and manufacturers like Medtronic and Johnson & Johnson anticipate a temporary dip in surgery volumes. However, weight loss in GLP-1 users also creates a bigger pool of patients eligible for certain surgeries who previously weren’t.

Side effects 52

Side effects Physicians Medical Patients 52

European Pharmaceutical Review

OCTOBER 18, 2022

Kite announced that the European Commission (EC) has approved the use of cell therapy Yescarta ® for treatment of patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), who relapse within 12 months or are refractory to, first-line chemoimmunotherapy. In the SOC arm, 83 percent of patients had Grade ?3

Side effects 102

Side effects Safety Patients Medical 102

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.

Side effects 88

Side effects Safety Medicine Patients 88

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 75

Side effects Safety Biopharma Recruitment 75

World of DTC Marketing

FEBRUARY 4, 2021

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. The trial was designed to assess the safety and efficacy of trofinetide against placebo in 187 Rett syndrome female patients aged five to 20 years.

Food and Drug Administration 72

Food and Drug Administration Pharmaceutical FDA Side effects 72

Pharmaceutical Technology

JANUARY 27, 2023

However, Briumvi is unlikely to appeal to patients who are already receiving Genentech’s Ocrevus or Novartis’s Kesimpta. As for Briumvi’s side effects, around 45% of patients experienced infections of the upper respiratory tract, which was 4% higher in comparison to Aubagio. All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Specialization 52

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

Side effects 144

Side effects Patients Manufacturing Safety 144

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

Management 69

Management Side effects Patients Safety 69

World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. Any discussion around DTC should acknowledge the following: 1ne: DTC is more effective for some health categories than others. What are the side effects?

Prescription 249

Prescription Doctors Side effects Marketing 249

European Pharmaceutical Review

APRIL 20, 2023

“These results are exciting… this treatment led to fewer days with migraine for people who had already tried up to four other types of drugs to prevent migraine and either had no improvement or had side effects that outweighed any benefits,” commented study author Dr Patricia Pozo-Rosich, PhD at Vall d’Hebron University Hospital in Barcelona, Spain.

Side effects 88

Side effects Safety Medical Pharmaceutical 88

PM360

MAY 25, 2023

Carl Marci, Chief Psychiatrist and Managing Director of Mental Health and Neuroscience at OM1 , about how the company is using its Mental Health and Neuroscience Real-World Data Network to help improve personalized treatment for mental health patients and increase awareness about issues related to mental health disorders.

Side effects 95

Side effects Medical Patients Networking 95

Contrarian Sales Techniques

JANUARY 25, 2023

This includes in-depth knowledge of the science behind the products, as well as their indications, contraindications, and potential side effects. It is also a matter of patient safety, as providing accurate information helps the healthcare provider to make the best decision for the patient.

Product Knowledge 52

Product Knowledge Pharmaceutical Sales Sales Pharmaceutical 52

European Pharmaceutical Review

FEBRUARY 9, 2023

The 126 patients were randomly assigned in a 1:1 ratio, with 62 receiving oral difelikefalin 2mg and 63 given placebo twice daily for eight weeks. points in patients receiving difelikefalin versus 2.4 points for patients receiving placebo. The reduction from baseline in the worst itch score at week eight was 4.0

Food and Drug Administration 79

Food and Drug Administration FDA Side effects Medicine 79

Pharma Leaders

APRIL 19, 2023

Diarrhea was the most common side effect using Xphozah in clinical trials. The NDA submission was supported by a comprehensive development programme, which included over 1,200 patients in three Phase III clinical trials, PHREEDOM, BLOCK and AMPLIFY, and two additional open-label Phase IV clinical trials, OPTIMIZE and NORMALIZE.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Food 52

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Supporting regulators. It focused on data from France, Germany and the UK.

Medicine 80

Medicine Safety Side effects Electronics 80