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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European Pharmaceutical Review

NOVEMBER 18, 2022

It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. The most common side effects observed were initial insomnia, irritability and dyskinesia. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over.

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Side effects Biopharma Safety Marketing 126

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

European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. The common, expected side effects were within expectations for a vaccine in this age group.

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Food and Drug Administration Patients Side effects Medicine 98

pharmaphorum

SEPTEMBER 6, 2022

The decision follows approval by the Medicines and Healthcare products Regulatory Agency (MHRA) last Saturday, which gave the green light for use of the new vaccine in those aged 12 years and above. Data from a clinical trial found side effects to typically be mild and self-resolving and to be no worse than the original booster dose.

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Side effects Medicine Safety Healthcare 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.

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Side effects Safety Medicine Patients 98

European Pharmaceutical Review

FEBRUARY 9, 2023

Oral difelikefalin could potentially relieve the moderate-to-severe itching associated with notalgia paresthetica, according to a study published in the New England Journal of Medicine. The double-blind, placebo-controlled trial was led by investigators at the Icahn School of Medicine at Mount Sinai.

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Food and Drug Administration FDA Side effects Medicine 97

European Pharmaceutical Review

DECEMBER 18, 2023

Treatment-related side effects included nausea and headache but were generally mild. “As In terms of safety, they noted that being a part of the group calmed their fears and increased their sense of preparedness to engage in therapy. Psychedelic medicines: are they gaining traction in Europe?

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Food and Drug Administration Patients Side effects Safety 116

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.

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Food and Drug Administration Side effects FDA Patients 105

Pharmaceutical Technology

NOVEMBER 23, 2022

The trial is designed to analyse the safety and efficacy of Hemgenix. A rise in liver enzymes, headache, increased blood enzyme level and flu-like symptoms among others were observed to be the most frequent side effects of the gene therapy. at six months and 24 months, respectively, following infusion.

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Food and Drug Administration FDA Side effects Food 105

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

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.

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Side effects Safety Government Pharmaceutical 85

pharmaphorum

JANUARY 3, 2023

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019.

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Side effects Biopharma Patients Medical 106

European Pharmaceutical Review

JUNE 16, 2023

According to Maximize Market Research , new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines. As the data landscape evolves, what is the most exciting innovation in clinical data management.

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Safety Electronics Recruitment Patients 111

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

Pharmaceutical Technology

MAY 25, 2023

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. There was no significant difference in side effect profiles of the two vaccines, based on the data. percentage points (96% CI, −0.3 for serogroup W to 20.5

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Side effects Medicine Safety Marketing 78

Pharmaceutical Technology

FEBRUARY 26, 2023

This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. A lot of immunotherapies cause side effects in the gastrointestinal tract, says Korman.

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Safety FDA Medicine Side effects 111

European Pharmaceutical Review

AUGUST 25, 2022

the promise of leveraging oncolytic viruses stands out because of their excellent safety profile, minimal predicted side effects and potent ability to kill cancer cells while leaving healthy cells unscathed2. Stem cells’ safety profile is well-established in human therapies.

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Side effects Safety Patients Engineering 111

Impetus Digital

AUGUST 2, 2024

Personalized Medicine AI can help develop precision medicine by analyzing patient data , including demographic, clinical, and genetic information, as well as information about their metabolism and microbes, environmental exposures, and lifestyle factors, to predict how different patients will respond to various therapies.

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Pharma Manufacturing Medicine Marketing 94

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.

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Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.” The sarcopenia study met both of its primary endpoints.

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Food and Drug Administration Side effects Pharmaceutical Leads 115

European Pharmaceutical Review

OCTOBER 20, 2022

These are all diseases that are highly prevalent in the population and are generally treated with drugs that are broadly immunosuppressive; while some of these drugs are beneficial and do ameliorate some symptoms, these patients experience side effects including increased susceptibility to infections.

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Engineering Side effects Manufacturing Patients 140

pharmaphorum

AUGUST 11, 2022

Next, pharmacists review the participant’s genetic results – along with health data such as drug, lifestyle, and food interactions – to customize a “Medication Action Plan” that members’ physicians can access to determine which drugs should be prescribed to increase safety and efficacy.

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Side effects Medical Prescription Patients 98

pharmaphorum

JANUARY 3, 2023

After passing on the reins of NICE, he was appointed chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), heading up the agency for two 3-year terms between 2014 and 2020. Dillon said in a statement that Rawlins was “an inspirational leader and always loyal and supportive to those around him. .”

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Medicine Side effects Safety Healthcare 52

Contrarian Sales Techniques

FEBRUARY 25, 2023

This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication. This includes potential side effects or adverse reactions to medications.

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Contrarian Sales Techniques

JANUARY 27, 2023

It can be challenging when you find yourself promoting products that seem to contradict each other, as it can raise questions about the effectiveness and safety of the products you're selling. However, it's important to understand that they work differently, have different side effects and are regulated differently.

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Sales Side effects Education Competition 52

European Pharmaceutical Review

DECEMBER 27, 2023

4 Manufacturing of CAR T-cell therapies: an overview In addition, multi-disciplinary teams must be established for in-house CAR T-cell therapy programmes to ensure maximum success and safety. Car-t “The living drugs”, immune checkpoint inhibitors, and precision medicine: A new era of cancer therapy. New England Journal of Medicine.

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Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Patients Leads Side effects 98

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Patients Leads Side effects 98

PM360

JUNE 24, 2024

Enabling Precision Medicine Every stakeholder is going to be impacted. It provides guidance and acts as a safety net for prescribers. It also flags possible side effects and interactions between drugs. Patients can look forward to electronic assistance that can return their voice or other lost abilities.

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Healthcare Healthcare Patients Side effects 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time.

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Specialization Leads Pharma Side effects 45

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. The field is on the cusp of some truly major breakthroughs, including the potential for precision medicine treatments.

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Patients Engineering Side effects Leads 98

European Pharmaceutical Review

AUGUST 14, 2023

This data, together with a favourable safety profile, make C21 a potential game-changer for IPF patients, particularly those who are currently not treated due to the side effects of the available drugs, according to Dalsgaard.

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Pharma Side effects Patients Manufacturing 98

pharmaphorum

SEPTEMBER 28, 2022

Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, side effects, and cost-effectiveness, among other factors. According to Ross Selby, Head of Global Patient Access at Takeda Oncology via NICE : “Uncertainty is the prime reason that medicines struggle with HTA.

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Biopharma Side effects Consulting Pharmaceutical products 52

PM360

AUGUST 9, 2022

The Modern Medicine Cabinet and Remote Therapy Monitoring Platform. KEEP’s Modern Medicine Cabinet and Remote Therapy Monitoring Platform provides real-time visibility into daily dosing events, informing proactive, data-driven interventions that connect patients to support when they need it most. References: 1. Jeff Wandzura, RPh.

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Prescription Medical Patients Side effects 105

Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma companies need tools like AI that can reliably improve this percentage without jeopardizing safety. The need for new medical treatments and drugs has never been greater.

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Food and Drug Administration Side effects Recruitment Safety 52

Medico Reach

FEBRUARY 8, 2023

The paradigm shift towards integrated, intelligent, and data-rich technologies is propelling the growth of medicines manufacturing. Here are some more applications of AI in healthcare and pharma Medicines discovery and design can improve drastically. The global pharmaceutical manufacturing market stood at USD 405.52 Let’s find out!

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