pharmaphorum

MARCH 2, 2021

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.

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Express Pharma

JUNE 12, 2024

Moderna has announced positive Phase III data for its COVID-19/influenza combination vaccine, mRNA-1083. Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments, “Moderna’s mRNA-1083 combines the mRNA-1010 seasonal influenza vaccine candidate with the mRNA-1283 next-generation Covid-19 vaccine candidate.

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Express Pharma

JUNE 3, 2024

mRESVIA is Moderna’s second approved product and reportedly the only RSV vaccine available in single-dose pre-filled syringes Moderna, announced that the U.S. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. The primary analysis with 3.7 per cent (95.88 per cent CI 66.0

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pharmaphorum

SEPTEMBER 9, 2020

It’s a bleak day in the fight against COVID-19, after the UK banned social gatherings of more than six people to contain growing numbers of new cases and the lead vaccine trial from AstraZeneca was halted because of a safety concern.

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Pharmaceutical Business Review

SEPTEMBER 2, 2024

The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705] is now authorised for active immunisation against Covid-19. Following the EUA, the vaccine is also recommended by the US Centers for Disease Control and Prevention (CDC). Our updated vaccine targets JN.1, 1.” “Our updated vaccine targets JN.1,

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Pharmaceutical Technology

AUGUST 4, 2022

Sinovac Biotech has reported that its Covid-19 vaccine, CoronaVac, obtained approval from the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People's Republic of China for usage in children of the age six months to three years.

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Pharmacy Times

JANUARY 4, 2023

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

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Pharmaceutical Business Review

NOVEMBER 10, 2023

Administered as a single dose by injection into the muscle, the vaccine has a live, weakened version of the chikungunya virus. It is expected to cause symptoms in individuals who receive the vaccine similar to those experienced by people with the disease. Initially, the vaccine received fast track and breakthrough therapy designations.

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Pharmaceutical Technology

NOVEMBER 20, 2022

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. The vaccine showed efficacy, with an encouraging safety and tolerability profile, in the trials. .

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus.

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PharmaShots

FEBRUARY 28, 2023

The signs and symptoms of a potential vaccine injury can vary. Other adverse reactions that could be attributed to a vaccine injury include neurological disorders such as seizures, autoimmune diseases, and allergic reactions. Read on to learn more about vaccine injuries and their symptoms.

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pharmaphorum

JANUARY 18, 2021

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 clinic in question switched to another lot of Moderna vaccine after closing for a few hours.

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pharmaphorum

OCTOBER 26, 2020

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. The post AZ, J&J COVID-19 vaccine trials okay to restart in US appeared first on.

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pharmaphorum

MARCH 16, 2021

The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the response to the pandemic in Europe. . It is a completely one-sided argument, statistically, that we need to be vaccinating,” he said. “I

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European Pharmaceutical Review

JULY 20, 2022

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. Researchers also study the long-term effects of medicines and vaccines, as well as the safety of new and advanced products.

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pharmaphorum

JANUARY 18, 2023

Moderna is looking to make a swift dash to the finish line with its respiratory syncytial virus (RSV) vaccine candidate, based on the same mRNA technology as its COVID-19 shots, with a filing in with the FDA in the first half of this year. The post With filing due soon, Moderna stakes a claim to the RSV vaccine market appeared first on.

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Pharmaceutical Technology

JULY 7, 2025

How will RFK Jr’s American dream for vaccines play out? The most common adverse reactions are diarrhoea, nausea, vulvovaginal candidiasis, genital pruritus and headache. Alembic plans to make Pivya available in the US in the fourth quarter of 2025.” ” Pivya has been proven safe in three studies.

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pharmaphorum

JANUARY 26, 2023

Moreover, research has shown that genetic testing can reduce adverse reactions to drugs by nearly one third. The combination of advanced long- and short-read genomic sequencing technologies holds great promise for precision oncology, and in the development of mRNA vaccines for certain cancers.

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STAT

SEPTEMBER 7, 2022

 Moving forward, the company will expand patient monitoring in the trial to watch for low magnesium levels, which had resulted in a serious adverse reaction in one study participant that led the FDA to suspend testing earlier this year. Food and Drug Administration on changes to the study’s plan , BioPharma Dive writes. Moving

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FDA Law Blog: Biosimilars

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

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Pharmaceutical Technology

MAY 15, 2023

A major strategy for OV development is genetic manipulation to weaken virus pathogenicity, enhance target selectivity, reduce adverse reactions, and/or insert exogenous therapeutic genes into the virus genome. OVs can be attenuated natural viruses or recombinant viruses.

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Pharmacy Times

JULY 2, 2025

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. OLC, a lanthanum-based phosphate binder, showed efficacy and tolerability in a phase 2 trial, with most patients achieving target serum phosphate levels.

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FADIC

JANUARY 12, 2023

Contraindications:  Hypersensitivity reaction to paracetamol or any of the other ingredients. Side effects: Infrequent adverse reactions may include anaphylaxis, skin rash, angioedema, thrombocytopenia, bronchospasm, Stevens-Johnson syndrome, hepatic dysfunction, and toxic epidermal necrolysis. g of sugar.

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Pharmacy Times

JUNE 12, 2025

3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Further, information presented on the adverse reaction data was inconsistent with the PI.

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European Pharmaceutical Review

JUNE 2, 2023

The new Intracellular Drug Delivery Centre CPI’s Intracellular Drug Delivery Centre will help predict the stability, efficacy, performance and any potential adverse reactions of RNA vaccines and therapeutics. Novel drug delivery systems like LNPs are needed for RNA therapeutic developments.

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pharmaphorum

JULY 5, 2021

vaccine effectiveness rates, reading the latest updates on local infection rates and cautiously deciding whether it’s safe or not to see their friends again. we have found macro, population-wide trends that largely echo those that have been reported by the CDC and vaccine manufacturers themselves.

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Amber

SEPTEMBER 12, 2024

If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO. Adverse Events: Most common adverse reactions (incidence ≥1%) are headache, dermatitis atopic, eczema, and eczema nummular.

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PharmExec

OCTOBER 3, 2022

New methods for signal detection offer the potential to identify adverse reactions from vaccines and drugs earlier. November 29th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products.

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European Pharmaceutical Review

DECEMBER 19, 2022

Treatment and care of patients with high-risk NMIBC, including those with CIS often involves removing the tumour and the use of the BCG vaccine to reduce the risk that the cancer will recur. Few effective treatment options exist for patients who develop BCG-unresponsive disease. Overall, 51 percent of patients achieved a CR.

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LifeProNow

APRIL 19, 2023

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

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Pharmacy Times

JULY 9, 2025

While no new adverse reactions were observed in this study, higher rates of hypersensitivity and infusion-related reactions were observed.

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Quality Matters

OCTOBER 13, 2021

In 2007 and 2008, nearly 150 patients died and hundreds more suffered serious adverse reactions after they were treated with heparin, a commonly used blood-thinning drug. Heparin is made from pig intestines, which at that time in China were subject to sharp price increases due to widespread pig deaths from “blue ear disease.”

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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. Third AZ dose generates strong variant response.

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pharmaphorum

SEPTEMBER 14, 2021

The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to its plan for third doses for people with weakened immune systems. A third dose of the shot was approved by the MHRA last week.

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