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.

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Safety Food and Drug Administration FDA Side effects 59

World of DTC Marketing

OCTOBER 29, 2020

While the product safety information page is among the top five pages visited what alarmed me was that time on the page was measured in seconds not minutes for most online visitors. Who could blame them when the safety information sounds like a medical journal? Let’s think about this for a minute. What about TV and online ads?

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Side effects Safety FDA Pharma 181

Pharmaceutical Technology

NOVEMBER 9, 2022

The approval came after the vaccine was found to satisfy the standards of safety, quality and effectiveness of the medicines regulator in the UK. This comprises wide-ranging data on the safety and effectiveness of the initial vaccine, clinical findings from the bivalent original/omicron BA.1

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Side effects Safety Medicine Healthcare 105

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. In conclusion, navigating the regulatory environment of pharmaceutical marketing requires a delicate balance between patient safety and industry innovation.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

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.

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Side effects Safety Patients Leads 90

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.

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Side effects Medicine Safety Marketing 84

World of DTC Marketing

JULY 21, 2021

3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.” ” Patients want to understand how the drug works and the potential side effects before starting therapy.

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Marketing Prescription Side effects Doctors 285

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.

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Side effects Safety Medical Marketing 52

Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Side effects Patients Marketing Safety 115

European Pharmaceutical Review

OCTOBER 9, 2023

A new approach to potassium-channel openers for epilepsy Critically, XEN1101 combines the effectiveness of potassium-channel openers with the safety of more traditional drugs, stated study lead author and neurologist Dr Jacqueline French. After a year or more, about 11 percent had no seizures.

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Side effects Recruitment Safety Medicine 95

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.

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Side effects Food and Drug Administration Safety Physicians 64

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

MARCH 25, 2024

Data supporting the positive recommendation of Emblaveo EMA’s positive recommendation for Emblaveo was based on the safety and efficacy data already available for each active substance and the results of two separate Phase III randomised studies REVISIT ( NCT03329092 ) and ASSEMBLE ( NCT03580044 ).

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Side effects Medicine Safety Patients 94

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.

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Food and Drug Administration FDA Side effects Safety 90

European Pharmaceutical Review

NOVEMBER 16, 2023

Side effects from treatment were similar to those associated with autologous stem cell transplants. No significant safety concerns were identified during the trials. Of these, 39 did not need a red blood cell transfusion for at least 12 months post-treatment.

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Safety Side effects Medicine Patients 96

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.

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Side effects Distribution Safety Patients 89

European Pharmaceutical Review

AUGUST 16, 2022

The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving. No serious safety concerns were identified.

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Safety Side effects Medicine Healthcare 102

MedCity News

JANUARY 30, 2024

AI can help by identifying the most effective treatment options and personalizing plans based on a patient’s unique characteristics and disease profile — potentially improving patient outcomes and reducing the risk of side effects.

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Side effects Ethics Medical Patients 127

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.

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Pharma Food and Drug Administration Side effects Safety 180

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. Plans for a Phase III clinical trial programme are underway.

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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.

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Side effects Safety Biopharma Recruitment 81

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.

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Side effects Safety Medical Pharmaceutical 88

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. Analytical evidence by the EMA indicated that there was a lack of safety concerns regarding approval of biosimilars compared with their reference medicines.

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Medicine Side effects Safety Doctors 91

Pharmaceutical Technology

AUGUST 15, 2022

After the vaccine was found to meet the standards of safety and quality, the regulatory agency granted the authorisation. According to the safety monitoring, side effects were generally mild and self-resolving, as well as in line with those reported for the original Moderna booster dose. 1 Omicron variant of concern.

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Side effects Safety Government Pharmaceutical 85

European Pharmaceutical Review

NOVEMBER 1, 2023

The safety profile of the adapted vaccine is expected to be like that of the originally authorised Nuvaxovid, EMA said. The most common side effects with Nuvaxovid XBB.1.5 Based on these data, the Committee concluded that Nuvaxovid XBB.1.5 is expected to trigger an adequate immune response against XBB.1.5.

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Side effects Medicine Safety Marketing 99

Contrarian Sales Techniques

FEBRUARY 25, 2023

This includes potential side effects or adverse reactions to medications. Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. This is before a drug can be approved for public use.

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Side effects Medical sales reps Insurance Pharmacology 52

European Pharmaceutical Review

NOVEMBER 18, 2022

The most common side effects observed were initial insomnia, irritability and dyskinesia. The efficacy and safety profile of Upstaza has been shown across clinical trials and compassionate use programmes. Significant improvements were shown to continue up to ten years post-treatment.

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Side effects Biopharma Safety Patients 126

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen.

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Management Side effects Patients Safety 75

World of DTC Marketing

DECEMBER 11, 2020

These are consumers who have relatively firm personal conviction in their decision to get vaccinated and may well be “first in line” when a vaccine is available to them—assuming continued positive safety and efficacy evidence. Importantly, they want to receive information from trusted sources, namely physicians.

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Physicians Media Side effects Safety 227

European Pharmaceutical Review

NOVEMBER 18, 2022

A clinical trial evaluated the safety and efficacy of Tzield in 76 patients with stage 2 type 1 diabetes. The most common side effects of Tzield were identified as lowered levels of certain white blood cells, rash and headache. Tzield is administered by intravenous infusion once per day for 14 days.

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Food and Drug Administration FDA Side effects Food 94

Pharmaceutical Technology

JANUARY 27, 2023

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. Some 48% of patients on Briumvi also suffered with infusion reactions.

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Marketing Side effects Safety Specialization 52

Pharma Leaders

JUNE 14, 2023

It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company. The company is advancing its ongoing Phase II trial, which has been designed for evaluating the efficacy and safety of EP-104IAR as a treatment candidate for knee OA. According to the U.S.

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Food and Drug Administration FDA Side effects Food 52

Pharmaceutical Technology

MARCH 13, 2023

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. Vomiting and diarrhoea are the most common side effects observed in the trial. The regulatory approval was supported by the data obtained from the pivotal Phase III LAVENDER trial.

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Food and Drug Administration Pharmaceutical FDA Side effects 72

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.

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Medicine Safety Side effects Electronics 81

European Pharmaceutical Review

OCTOBER 18, 2022

The trial had a safety profile that was consistent with previous studies. Among the 170 axicabtagene ciloleucel-treated patients evaluable for safety, Grade ?3 Additionally, axicabtagene ciloleucel demonstrated a 2.5-fold

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Side effects Safety Patients Medical 103

European Pharmaceutical Review

NOVEMBER 14, 2022

CHMP’s safety update. The CHMP endorsed measures recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), to minimise the risk of serious side effects (cardiovascular conditions, blood clots, cancer and serious infections) of janus kinase (JAK) inhibitors for treating several chronic inflammatory disorders.

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Medicine Side effects Safety Pharmaceutical 83

Pharma Leaders

APRIL 19, 2023

Diarrhea was the most common side effect using Xphozah in clinical trials. The Phase III trials were designed to assess the efficacy and safety of Xphozah. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3).

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Food and Drug Administration FDA Side effects Food 52