Express Pharma

DECEMBER 13, 2023

The Korean Ministry of Food and Drug Safety (MFDS) has recently mandated the reporting of any suspected adverse reactions, including T-cell malignancies, to the Korea Institute of Drug Safety and Risk Management. The collected data can further be used to inform future research on CAR-T therapies.”

Adverse Reactions 105

Adverse Reactions 105

Express Pharma

JUNE 18, 2024

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Fatal adverse reactions occurred in 1.6

Chemotherapy 59

Chemotherapy Adverse Reactions Immunity Immunization 59

LifeProNow

MARCH 10, 2023

The most common adverse reactions reported in at least 2% of patients treated with ZAVZPRET and at a frequency greater than placebo were taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort and vomiting. IMPORTANT SAFETY INFORMATION Contraindications: Hypersensitivity to ZAVZPRET or any of its components.

Adverse Reactions 100

Adverse Reactions 100

European Pharmaceutical Review

JANUARY 8, 2024

This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. The post Innovative biologic for myasthenia gravis granted European approval appeared first on European Pharmaceutical Review.

Adverse Reactions 98

Adverse Reactions 98

European Pharmaceutical Review

SEPTEMBER 2, 2022

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

pharmaphorum

JUNE 29, 2021

Giving one dose each of AstraZeneca and Pfizer COVID-19 vaccines provides good protection against the SARS-CoV-2 virus, but may be associated with more adverse reactions, according to new clinical trial data.

Vaccines 128

Vaccines Adverse Reactions Immunization Immunity 128

Express Pharma

JUNE 3, 2024

The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. by the 2024/2025 respiratory virus season,” the statement informs. No serious safety concerns were identified in the Phase 3 trial. The post Moderna receives U.S.

Vaccines 81

Vaccines Adverse Reactions Packaging 81

RX Note

APRIL 9, 2023

Introduction Clinical Pharmacology powered by ClinicalKey provides current, dependable drug information, including off-label indications, to guide treatment recommendations. Interesting Features Extensive search options Global drug name search Drug search by indications (include off-label use), adverse drug reactions and contraindications.

Clinical Pharmacology 40

Clinical Pharmacology Adverse Reactions Labelling 40

Express Pharma

JUNE 2, 2023

This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. These systems enable real-time monitoring, accurate data capture, and seamless integration of information across various stakeholders, from manufacturers to healthcare providers.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

pharmaphorum

JANUARY 19, 2021

For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.”. No one ever knows what to do with you! It’s a pure guessing game!”.

Adverse Reactions 133

Adverse Reactions Communication Hospitals Compounding 133

European Pharmaceutical Review

OCTOBER 27, 2023

A new sixty-day limit would be implemented for those conducting a trial to respond to Requests for Further Information (RFI) from the MHRA or Research Ethics Committees (RECs). This would provide sufficient time for sponsors to prepare responses to satisfy regulators, according to the report.

Adverse Reactions 105

Adverse Reactions 105

pharmaphorum

MARCH 2, 2021

That information is then immediately uploaded to the cloud for employees to reference. Adverse reactions to the vaccine. After collecting the information, they print a plastic barcode label that can send the recipient’s vaccination records to the cloud with a simple scan. Daily vaccination numbers. Vaccine supply levels.

Vaccines 119

Vaccines Adverse Reactions Documentation Labelling 119

pharmaphorum

AUGUST 6, 2020

GSK has not released information about its plans for pricing in the US, but antibody drugs tend to be less expensive than CAR-Ts, which are manufactured using a costly process that involves harvesting a patient’s cells and modifying them to fight cancer.

Adverse Reactions 87

Adverse Reactions Packaging 87

pharmaphorum

JANUARY 22, 2021

It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC). The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen.

Adverse Reactions 71

Adverse Reactions 71

Amber

SEPTEMBER 12, 2024

For more information, please visit www.Amber Pharmacy.com or contact Amber Specialty Pharmacy’s customer service team at (888) 370-1724. Adverse Events: Most common adverse reactions (incidence ≥1%) are headache, dermatitis atopic, eczema, and eczema nummular. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Specialty Pharmacies 52

Specialty Pharmacies Adverse Reactions Customer Service Vaccines 52

Amber

AUGUST 3, 2022

Building relationships with patients allows us to better manage adverse reactions, solve financial issues, and answer any questions along the way. For more information about Amber Specialty Pharmacy, call (888) 370-1724. Our Board Certified Oncology Pharmacists are easily available for patients. OMAHA, Neb.

Specialty Pharmacies 52

Specialty Pharmacies Adverse Reactions 52

RX Note

JULY 30, 2023

Overdose (including prescribing or administration errors) Therapeutic failure Drug interactions Drug withdrawal NOTE: All adverse reactions are adverse drug event, but that not all adverse drug events will be adverse drug reactions. Does the reaction improve when a specific treatment is given?

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

The Pharmacist

MAY 2, 2024

A patient alert card warning of potential psychiatric and sexual side effects of finasteride will be introduced into packs the medicine this year, following a review into the drug’s safety.

Adverse Reactions 128

Adverse Reactions 128

pharmaphorum

JULY 5, 2021

That score – and the deep, nuanced information behind it – could not only drive a faster, more confident return to normal, it could also help people who are currently sitting on the sidelines. The medical community has learned so much over the last decade of advances in personalised medicine and immune science.

Immunity 105

Immunity Immunization Health and Personal Care Stores Vaccines 105

PharmD Live

AUGUST 29, 2022

Yet there is an additional problem of overdoses due to limited information and understanding by physicians working inside their practices. Because of this it is imperative patients on multiple medications receive close monitoring for signs of adverse reactions. PharmD Live’s solutions are personalized and proactive.

Adverse Reactions 98

Adverse Reactions Diabetes Medical Schools Documentation 98

PharmaShots

JUNE 29, 2023

For more information connect with us at connect@pharmashots.com 11 for 1-5yrs. & 10 for ≥5yrs. Your go-to media platform for customized news ranging for multiple indications.

Diabetes 40

Diabetes Adverse Reactions 40

PharmaShots

JUNE 6, 2023

with no new safety signals, the discontinuation rate due to adverse reactions (6% vs 4%) Ref: Gilead | Image: Gilead Related News:- Gilead and Arcus Present P-II Study (ARC-7) Results of Domvanalimab as 1L Treatment of Non-Small Cell Lung Cancer at ASCO 2023 PharmaShots! vs 11.2mos.), PFS rates at 6/12/18mos. vs 29.4%)/ (21.7%

Adverse Reactions 40

Adverse Reactions Chemotherapy 40

PharmaShots

MAY 26, 2023

In both trials, no new safety signals and no additional adverse reactions to Veklury were observed If Veklury was granted by the EC, it will become the first authorized antiviral treatment across all stages of renal disease. For more information connect with us at connect@pharmashots.com renal impairment, incl. renal impairment.

Adverse Reactions 40

Adverse Reactions Hospitals 40

PharmaShots

JUNE 23, 2023

For more information connect with us at connect@pharmashots.com Your go-to media platform for customized news ranging for multiple indications.

Adverse Reactions 40

Adverse Reactions 40

Big Molecule Watch

SEPTEMBER 25, 2023

When information specific to the reference product is described in the biosimilar or interchangeable biosimilar product’s labeling (for example, data from clinical trials of the reference product in the ADVERSE REACTIONS and CLINICAL STUDIES sections), the reference product’s proper name should be used.

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

LifeProNow

MAY 8, 2023

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC). For more information, visit clinicaltrials.gov. The median time to onset of neurologic events was 11 days (range: 7 to 17 days).

Chemotherapy 130

Chemotherapy Adverse Reactions 130

FDA Law Blog: Biosimilars

MARCH 7, 2024

FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information. In another update, the recent draft guidance added “entities reviewing safety data” and adaptation committees.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

pharmaphorum

MARCH 10, 2021

The US biotech said the suspected serious adverse reaction reported in the phase 1/2 study of LentiGlobin gene therapy for sickle cell disease was unlikely to be related to the virus vector used in the therapy, used to deliver the genetic material to the body.

Adverse Reactions 59

Adverse Reactions 59

Pharma in Brief

JULY 7, 2020

The PMPRB accepted that there was a slightly elevated incidence of adverse reactions as well as higher efficacy for DIFFERIN XP when compared to DIFFERIN. However, the Board concluded that these differences did not outweigh the clinical similarities.

Adverse Reactions 40

Adverse Reactions Dosage 40

The Thyroid Pharmacist

OCTOBER 1, 2022

For more in-depth information, I encourage you to read these linked articles about each nutrient. Special Considerations: If you have an adverse reaction to thiamine (which is rare), I recommend detoxifying the liver with a liver support protocol. Vitamin B12. Iron/ Ferritin (the iron storage protein).

Adverse Reactions 98

Adverse Reactions Dosage Immunity Immunization 98

PharmaState Academy

MAY 29, 2024

a) Withdraw the drug from the market temporarily b) Issue a public statement without halting promotion c) Continue promotion with added warnings d) Only inform healthcare professionals Withdrawing the drug temporarily ensures patient safety and allows for investigation and appropriate measures to be taken.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Adverse Reactions Communication 52

RX Note

JUNE 9, 2023

Category D - There is positive evidence of human foetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Categories may not change despite the availability of new information.

Labelling 52

Labelling Adverse Reactions 52

LifeProNow

APRIL 19, 2023

Important Safety Information BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Adverse Reactions 100

Adverse Reactions Vaccines Immunization Immunity 100

FDA Law Blog: Biosimilars

JUNE 13, 2023

MISLEADING PRESENTATION OF RISK INFORMATION Recorlev is a drug for endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or was not curative. In other words, this is a drug that requires serious risk information to be presented. Would that it were so!

Adverse Reactions 40

Adverse Reactions 40

LifeProNow

APRIL 30, 2023

For more information on the EMBARK trial (NCT02319837) go to www.clinicaltrials.gov. Important Safety Information XTANDI (enzalutamide) is indicated in the U.S. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death.

Adverse Reactions 130

Adverse Reactions Chemotherapy Diabetes 130

Pharmaceutical Technology

JUNE 15, 2023

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. AI-based analysis can provide insight into participant behavior that informs how researchers design trials.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

Digital Pharmacist

OCTOBER 24, 2022

Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Common adverse effects were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection. .

Adverse Reactions 75

Adverse Reactions Labelling Pharmacy Management Immunization 75