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).

Healthcare 84

Healthcare Healthcare Electronics Safety 84

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. Clinically, it is common practice for doctors to rotate patients between different biologics. New regulatory guidance could lead to UK biosimilar boom.

Medicine 91

Medicine Side effects Safety Doctors 91

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. Some 48% of patients on Briumvi also suffered with infusion reactions.

Marketing 52

Marketing Side effects Safety Patients 52

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. Findings presented at EADVC 2022.

Management 85

Management Side effects Patients Safety 85

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months. MSCs and CAR-Ts for lupus.

Side effects 144

Side effects Patients Manufacturing Safety 144

pharmaphorum

JULY 6, 2022

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. Now, in addition to doctors and providers, the FDA announced pharmacists with your medical information can prescribe Paxlovid to patients.

FDA 111

FDA Doctors Side effects Patients 111

European Pharmaceutical Review

DECEMBER 7, 2022

state the therapy could help reduce side effects and safety concerns. At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 months as compared to a historical mPFS of 4.5

Pharma 95

Pharma Side effects Safety Patients 95

PM360

MAY 25, 2023

above pre-pandemic levels by Q2 2022. Currently, OM1 can harness real-world data from clinical notes obtained from more than 9,000 clinicians working in 2,500 clinics across all 50 states, and the company recently added data from more than 148,000 patients with schizophrenia and bipolar this past March. million people.

Side effects 95

Side effects Medical Patients Networking 95

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.

Medicine 80

Medicine Safety Side effects Electronics 80

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.

Safety 102

Safety Electronics Recruitment Medical 102

European Pharmaceutical Review

DECEMBER 14, 2023

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. But from a safety point of view, observational studies can be more representative of the population the drug will serve. As of October 2023, 62.93

Safety 113

Safety Medicine Competition Networking 113

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. Back in April 2022, the microbiome-focused biotech Kaleido Therapeutics folded due to financial and regulatory setbacks.

Safety 111

Safety FDA Medicine Side effects 111

pharmaphorum

SEPTEMBER 11, 2022

A personalised cell therapy based on tumour-infiltrating lymphocyte (TIL) cells has been shown to be more effective at improving progression-free survival than Bristol-Myers Squibb’s immunotherapy Yervoy in patients with advanced melanoma.

Side effects 103

Side effects Patients Engineering Management 103

Nixon Gwilt Law

NOVEMBER 5, 2021

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) finalized the Medicare Physician Fee Schedule for Calendar Year 2022 (the “Final 2022 MPFS” or the “Final Rule”). This means that, even if the PHE ends in 2022, providers may bill for Category 3 telehealth services until the close of the following year.

Physicians 52

Physicians Professional Services Side effects Medical 52

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.

Patients 59

Patients Pharma Education Media 59

European Pharmaceutical Review

AUGUST 25, 2022

IN 2022, treating glioblastoma (GBM) remains an uphill battle. Current therapeutic options show limited success and neuro-oncology teams often struggle to balance their benefits with a patient’s quality of life. However, patient survival rates remain low, with the standard of care delivering a progression?free

Side effects 99

Side effects Safety Patients Engineering 99

PM360

NOVEMBER 29, 2022

Many companies in the cell and gene therapy space are dedicated to bringing these novel therapies to the patients who need them. Researchers are diligently creating new methods for cell and gene editing as well as therapeutic delivery to increase safety, accessibility, and affordability.

Patients 111

Patients Safety Marketing Side effects 111

European Pharmaceutical Review

OCTOBER 20, 2022

In recent years there has been significant development within the cell therapy field, as chimeric antigen receptor (CAR) T-cell therapy demonstrated an ability to transform the treatment of patients with haematological malignancies.

Engineering 124

Engineering Side effects Manufacturing Patients 124

pharmaphorum

SEPTEMBER 11, 2022

All told, 7% of patients treated with SpringWorks’ therapy had a complete response to treatment, and 95% of side effects liked to the drug were mild (grade 1 or 2), most commonly diarrhoea, rash, and elevated levels of phosphate in the blood. Oncology (@myESMO) September 10, 2022. link] #rarecancer.

Side effects 52

Side effects Leads Safety Patients 52

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The NSAA measures functional motor abilities in DMD patients.

FDA 126

FDA Safety Pharmaceutical Patients 126

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5

Prescription 105

Prescription Medical Side effects Patients 105

PM360

OCTOBER 13, 2023

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility.

Healthcare 59

Healthcare Healthcare Doctors Pharma 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. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.

Consulting 59

Consulting Manufacturing Side effects Safety 59

European Pharmaceutical Review

DECEMBER 27, 2023

Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks. As a result, many patients waiting for the CAR T cells to be infused will need additional therapy (bridging therapy) against the malignance.

Manufacturing 85

Manufacturing Food and Drug Administration Patients Pharma 85

pharmaphorum

SEPTEMBER 12, 2022

The full data will be presented as a late-breaker later today, so may be subject to change, and for now shows a solid reduction in disease progression or death in patients with the KRAS inhibitor in KRAS G12C-mutated non-small cell lung cancer (NSCLC) compared to docetaxel, but no improvement in overall survival.

Side effects 52

Side effects FDA Patients Safety 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

PM360

JULY 13, 2023

Here are twelve of the best examples of programs, strategies, solutions, technology, and more that companies have developed or are using to keep patients on their prescribed therapies. But outdated manual processes are complex and leave many patients out. But outdated manual processes are complex and leave many patients out.

Education 89

Education Medical Media Patients 89

Medico Reach

FEBRUARY 8, 2023

from 2022 to 2030, the pharma industry will reach USD 9,241.34 The Emergence of the Pharmacovigilance Market Medicines and vaccines often have unwanted and severe side effects. Such results call for stringent vigilance on the medicines quality and after-effects, nudging the emergence of the pharmacovigilance market.

Pharma 52

Pharma Medicine Marketing Prospecting 52