European Pharmaceutical Review

MARCH 25, 2024

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria.

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Side effects Medicine Safety Patients 92

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

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. New regulatory guidance could lead to UK biosimilar boom.

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Medicine Side effects Safety Doctors 89

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

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. The medicine takes over a week to break down in the body.

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Side effects Recruitment Safety Medicine 93

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. Side effects from treatment were similar to those associated with autologous stem cell transplants.

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Safety Side effects Medicine Patients 93

European Pharmaceutical Review

AUGUST 16, 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. 1) and the original 2020 strain.

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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 128

European Pharmaceutical Review

NOVEMBER 1, 2023

It was developed to target Omicron XBB in line with recommendations from the European Medicines Agency’s Emergency task force (ETF) as well as other international regulators and the World Health Organization. The safety profile of the adapted vaccine is expected to be like that of the originally authorised Nuvaxovid, EMA said.

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Side effects Medicine Safety Marketing 97

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).

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Healthcare Healthcare Electronics Safety 82

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 86

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 83

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 90

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 Patients 126

European Pharmaceutical Review

DECEMBER 14, 2023

Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe.

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Safety Medicine Competition Networking 112

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

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

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 85

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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Side effects Medicine Safety Healthcare 52

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 77

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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Side effects Medical sales reps Insurance Pharmacology 52

Contrarian Sales Techniques

FEBRUARY 26, 2023

There was an article that examine the market for generic medicines in the Malaysia, following the introduction of the first generic patent in 2010 and the introduction of generic patent law in 2012. The market for medicines in Malaysia is divided between private clinics, private clinics, and pharmacies.

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Pharmaceutical Medicine Government Side effects 52

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 Ethics 52

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 Competition 103

World of DTC Marketing

DECEMBER 23, 2020

According to a study in the Journal for American Board of Family Medicine “respondents (76%) said they were likely to ask a health care provider about advertised drugs; 26% said they had already done so. What are the side effects? That belief is out the window. Today people go online to learn more about the drug.

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Prescription Doctors Side effects Marketing 249

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 104

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

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

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

pharmaphorum

DECEMBER 12, 2022

With that efficacy data, odronextamab looks like it could be a challenger to Lunsumio , although there was some discussion at ASH about its safety, with 10% of patients discontinuing treatment because of side effects and five deaths “where the relationship to odronextamab treatment could not be excluded.”

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Side effects Safety FDA Patients 52

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 97

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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Pharma Medicine Marketing Prospecting 52

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 Side effects Leads Patients 93

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 Side effects Leads Patients 92

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 88

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

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Networking Consulting Safety Side effects 59

European Pharmaceutical Review

JULY 20, 2023

The Alliance for Regenerative Medicine (ARM) stated in a 2022 report that adeno-associated viral vector (AAV) is the primary vector in ongoing gene therapy trials. She stated that some of the key concerns were around viral safety, immunogenicity and the fact that long term side effects are unknown.

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Consulting Side effects Manufacturing Safety 58