European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 Treatment-related side effects included nausea and headache but were generally mild. “As The post Psilocybin-assisted therapy reduces depressive symptoms in cancer patients appeared first on European Pharmaceutical Review.

Food and Drug Administration 116

Food and Drug Administration Patients Side effects Safety 116

Pharmaceutical Technology

MAY 25, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

Side effects 52

Side effects Medicine Recruitment Doctors 52

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

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 98

Side effects Medicine Safety Marketing 98

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 104

Patients Food and Drug Administration Side effects Safety 104

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 96

Patients Food and Drug Administration Side effects Food 96

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

Pharmaceutical Technology

MAY 16, 2023

Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age. All but one patient in the trial received a single dose of Caldolor. Caldolor has already obtained FDA approval for pre-operative administration.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

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 98

Food and Drug Administration Patients Side effects Medicine 98

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 Manufacturing 203

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 Marketing 126

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 114

Safety Side effects Patients Medicine 114

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 98

Side effects Distribution Safety Patients 98

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 110

Side effects Recruitment Safety Medicine 110

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

DECEMBER 5, 2022

A medium or high dose of its lead, CD19-targeting CAR-NK therapy candidate NKX19 achieved complete responses in seven out of 10 patients with relapsed or refractory non-Hodgkin lymphoma (NHL), driving their cancer into remission.

Side effects 98

Side effects Safety Patients Leads 98

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 98

Side effects Safety Patients Leads 98

PM360

SEPTEMBER 15, 2022

PM360 asked industry experts what it takes to be a patient-first organization and how companies can better ensure they are delivering experiences that meet patients’ expectations. Specifically, we asked them: What is required today for life sciences companies to truly practice a patient-first approach? Matt Flesch.

Patients 98

Patients Education Management Side effects 98

Pharmacy Times

NOVEMBER 1, 2023

Robert Sidonio Jr, MD, MSc, shares insights on monitoring and managing side effects in hemophilia A treatment to ensure patient safety and adherence.

Side effects 29

Side effects Management Safety Patients 29

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

Safety 59

Safety Food and Drug Administration FDA Side effects 59

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 98

Side effects Safety Biopharma Recruitment 98

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 111

Side effects Safety Patients Medical 111

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 100

Management Side effects Patients Safety 100

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 98

Medicine Side effects Safety Doctors 98

Pharma Marketing Network

MARCH 5, 2025

With millions of healthcare professionals (HCPs) and patients turning to Google for medical information, paid search ads present a huge opportunity for pharma brands to boost engagement and conversions. Targeting Patients and Caregivers Patients search for symptom relief, treatment options, and medication costs.

Management 52

Management Pharma Marketing Prescription 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

OCTOBER 7, 2024

New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials. Furthermore, 70 percent of these patients had a complete response.

Food and Drug Administration 105

Food and Drug Administration Side effects FDA Patients 105

World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. 6ix: Safety information needs context. In clinical trials, how many people experienced a listed side effect? 7even: Real patient stories. First impressions are 94% design-related.

Pharma 180

Pharma Medical Side effects FDA 180

Pharma Marketing Network

NOVEMBER 15, 2024

In a world where patients and healthcare professionals (HCPs) search for drug information online, PPC lets you stay top-of-mind. Example: When advertising a drug like Lyrica , your ad must state potential side effects and direct users to detailed safety information. Why PPC Matters in Pharma Marketing Why invest in PPC?

Marketing 52

Marketing Pharma Side effects Medical 52

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 98

Food and Drug Administration FDA Side effects Food 98

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 98

Food and Drug Administration FDA Side effects Safety 98

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 98

Side effects Safety Medicine Patients 98

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

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 97

Medicine Safety Side effects Electronics 97

European Pharmaceutical Review

OCTOBER 10, 2022

The FDA initially approved Boostrix in 2005 as a vaccine to protect against Tdap in patients from 10 years old to 18. Side effect data related to those given the non-US variation during pregnancy was consistent with data for individuals who were given the non-US formulation post labour.

FDA 105

FDA Food and Drug Administration Side effects Food 105

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 98

Food and Drug Administration Side effects Safety Food 98

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 97

Food and Drug Administration FDA Side effects Medicine 97