article thumbnail

Rare MIS-C Does Not Appear to Impact COVID-19 Vaccine Safety in Children

Pharmacy Times

Children who experienced COVID-19-induced multisystem inflammatory syndrome did not experience severe adverse reactions following COVID-19 vaccination.

article thumbnail

Hypercholesterolemia Counseling Improves Adherence

Pharmacy Times

Pharmacist education also helps prevent adverse reactions, maximizes outcomes for the symptomless disease.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Advanced methodologies for signal detection in emergency-use cases (COVID-19)

PharmExec

New methods for signal detection offer the potential to identify adverse reactions from vaccines and drugs earlier.

article thumbnail

EC approves Regeneron’s immunotherapy for cervical cancer

Pharmaceutical Technology

Additionally, 21% of subjects who received Libtayo had immune-mediated adverse reactions. Hypothyroidism, hyperthyroidism, immune-mediated pneumonitis, hepatitis, colitis and skin adverse reactions were reported to be the most frequent immune-mediated adverse reactions.

article thumbnail

mRNA vaccine trial shows efficiency in older adults with RSV

European Pharmaceutical Review

To date, most solicited adverse reactions were mild or moderate. The most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. mRNA-1345 demonstrated vaccine efficacy (VE) of 83.7

article thumbnail

Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Diarrhoea, decreased appetite, constipation, fatigue, musculoskeletal pain, neutropenia, vomiting, anaemia, leukopenia, thrombocytopenia, increased transaminases, nausea, and alopecia are the most common adverse reactions observed in the trial.

article thumbnail

Therapeutic-first for cold agglutinin disease haemolytic anaemia

European Pharmaceutical Review

The study found 96 percent of patients who recieved Enjaymo ® and all participants in the placebo group experienced at least one treatment emergent adverse event (TEAE). Serious adverse reactions (SARs) were reported in 13 percent (3/24) of patients who received the mAb.

article thumbnail

Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

Nausea, fatigue, vomiting, reduced neutrophil count, alopecia and anaemia among others were observed to be the most prevalent adverse reactions.

article thumbnail

FDA approves first gene therapy for Haemophilia B

European Pharmaceutical Review

Despite advancements in the treatment of haemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” stated Dr Peter Marks, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

article thumbnail

BioCryst and Swixx BioPharma partner for commercialisation of Orladeyo

Pharmaceutical Technology

Back pain, gastroesophageal reflux disease, vomiting, abdominal pain, and diarrhoea are the most common adverse reactions observed in patients receiving Orladeyo.

article thumbnail

FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

Mucositis, vomiting, nausea, febrile neutropenia, alopecia and reduced appetite among others were reported to be the most prevalent non-laboratory adverse reactions reported.

article thumbnail

FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The most common adverse reactions (ARs) included bladder discharge, fatigue, bladder spasm, urinary urgency, haematuria (presence of blood in urine), chills, fever, and painful urination.

article thumbnail

EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

Tenderness/pain at the injection site, headache, myalgia, fatigue and malaise were the most common adverse reactions reported.

article thumbnail

NMPA of China approves Takeda’s Exkivity for NSCLC

Pharmaceutical Technology

Rash, decreased appetite, paronychia, and diarrhoea are the most common adverse reactions (TRAEs) related to the treatment.

article thumbnail

First paediatric EC approval of HIV drug

European Pharmaceutical Review

In this study, no new adverse reactions (ARs) have been observed in paediatric subjects aged two years and older living with HIV-1 compared to adults.

article thumbnail

How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health.

article thumbnail

Health Canada grants expanded authorisation for Novavax’s Covid-19 vaccine

Pharmaceutical Technology

Additionally, data from these trials showed that local and systemic reactions following the booster dosing lasted for a median duration of nearly two days.

article thumbnail

FDA approves Regeneron’s Libtayo and chemotherapy combination for NSCLC

Pharmaceutical Technology

Musculoskeletal pain, fatigue, alopecia, nausea, peripheral neuropathy and decreased appetite are the most common adverse reactions.

article thumbnail

FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The most common adverse reactions with Sunlenca were injection site reactions (swelling, pain or redness) and nausea.

article thumbnail

Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong

Pharmaceutical Technology

No severe adverse reactions were observed six months following two vaccination doses in children aged six to 35 months.

article thumbnail

Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established.

article thumbnail

EC grants approval for BMS’ Opdualag to treat melanoma

Pharmaceutical Technology

Fatigue, musculoskeletal pain, rash, arthralgia diarrhoea and pruritus among others were found to be the most prevalent adverse reactions in the trial.

article thumbnail

Novavax and SII receive registration for Covid-19 vaccine in South Africa

Pharmaceutical Technology

Additionally, a reduced number of serious and severe adverse events were reported, which were balanced between the vaccine and placebo arms.

article thumbnail

A new dawn of the genomic age: five areas set to be transformed in 2023

Pharma Phorum

Understanding individual drug reactions and metabolism Pharmacogenomics is emerging as an important area. Moreover, research has shown that genetic testing can reduce adverse reactions to drugs by nearly one third. 2022 was a banner year for genomics.

article thumbnail

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Pharma Phorum

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6%

article thumbnail

AZ halts COVID-19 vaccine after safety scare, as UK faces ‘second wave’

Pharma Phorum

The nature of the adverse reaction is not known but the participant is expected to recover said Stat, citing a source close to the matter. According to Stat, researchers are looking for similar adverse reactions by looking through databases held by Data and Safety Monitoring Boards.

article thumbnail

Assessing the scale of pharmaceutical crime using API content

European Pharmaceutical Review

Substandard and falsified medicines pose a significant threat to patients and health systems globally because they cause a range of problems from being ineffective to, in the worst case, causing severe adverse reactions and avoidable deaths.

article thumbnail

BeiGene’s Brukinsa FDA approved for CLL/SLL

Pharma Phorum

The most common adverse reactions noted in the clinical trials of zanubrutinib were neutrophil count decrease (42%), upper respiratory tract infection (39%), platelet count decrease (34%), haemorrhage (30%), and musculoskeletal pain (30%).

article thumbnail

Allergic reactions prompt Moderna COVID vaccine pause in California

Pharma Phorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. The post Allergic reactions prompt Moderna COVID vaccine pause in California appeared first on.

article thumbnail

Novavax’s Covid-19 vaccine gets approval in South Korea for adolescents

Pharmaceutical Technology

Tenderness/pain at the site of injection, headache, fatigue, myalgia and malaise was seen to be the most common adverse reactions in the trial. .

article thumbnail

FDA approves Zynteglo gene therapy for beta-thalassemia patients

European Pharmaceutical Review

Patients should also be monitored for hypersensitivity reactions during Zynteglo administration and should be monitored for thrombocytopenia and bleeding. .

article thumbnail

Sanofi’s Sarclisa gains new US multiple myeloma indication

Pharma Phorum

The most frequent adverse reactions (occurring in 20% or more of patients) for Sarclisa versus the control arm included upper respiratory tract infection, infusion-related reactions and fatigue. In the trial, 8% of patients dropped out because of adverse events and 2.8%

article thumbnail

Gilead’s Trodelvy approved in metastatic urothelial cancer

Pharma Phorum

Among 113 evaluable treated metastatic UC patients the most common adverse reactions were diarrhoea (72%), anaemia (71%), fatigue (68%), neutropenia (67%), nausea (66%), alopecia (49%), decreased appetite (41%), constipation (34%), vomiting (34%) and abdominal pain (31%).

article thumbnail

CHMP adopts positive opinion for haemophilia B gene therapy

European Pharmaceutical Review

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). No serious adverse reactions (SARs) were reported.

article thumbnail

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Pharma Phorum

The most frequent serious adverse reactions reported in 83% of people treated with Venclexta plus azacitidine, were low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal; 19%) and bleeding (6%).

article thumbnail

EC approves Kite’s cell therapy for treating acute lymphoblastic leukaemia

Pharmaceutical Technology

Additionally, 25% and 32% of the subjects had Grade 3 or higher cytokine release syndrome and neurologic adverse reactions, respectively, and were found to be well managed.

article thumbnail

NICE says yes to BeiGene’s Brukinsa after Scottish nay

Pharma Phorum

” The document notes however that there is a high unmet need for an effective and well tolerated treatment for WM “where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits.”

article thumbnail

With filing due soon, Moderna stakes a claim to the RSV vaccine market

Pharma Phorum

Safety and tolerability data was also good, said Moderna, with a rate of severe (Grade 3 or greater) systemic adverse reactions of 4% for mRNA-1345 and 2.8% Look out, Pfizer and GSK.

article thumbnail

US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children

Pharmaceutical Technology

Imbruvica's safety was reported to be in line with its established profile and the observed adverse reactions (ARs) were similar to those seen in adults with moderate to severe cGVHD.

article thumbnail

EC approves Libtayo® for metastatic cervical cancer

European Pharmaceutical Review

Immune-mediated adverse reactions (ARs) occurred in 21 percent of patients treated with Libtayo ® and led to permanent discontinuation in 4.6 Adverse events (AEs) were serious in 32.4 The European Commission (EC) has approved Regeneron Pharmaceuticals, Inc.’s

article thumbnail

Non-vaccine nasal spray could protect against COVID-19

Pharma Phorum

That could be important if it takes longer than expected to bring vaccines and antibodies to market, said a spokesman for the companies, pointing to the news this week that AstraZeneca has halted phase 3 trials of its COVID-19 vaccine candidate AZD1222 after a serious adverse reaction in one patient.

article thumbnail

AZ, J&J COVID-19 vaccine trials okay to restart in US

Pharma Phorum

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.

article thumbnail

Boehringer sells drug safety software to ArisGlobal

Pharma Phorum

German drugmaker Boehringer Ingelheim has sold an artificial intelligence-powered software platform it developed to monitor drug safety data to ArisGlobal, which provides cloud software to life sciences companies.