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. 3 Moreover, digital platforms can be tailored to the needs of patients and healthcare professionals, offering accessible, trustworthy and up-to-date information on medicines precisely when required.

Healthcare 98

Healthcare Healthcare Safety Electronics 98

Pharmaceutical Technology

OCTOBER 4, 2022

The type 2 diabetes (T2D) space recently witnessed a new approval: on 15 September, the European Commission (EC) authorised Eli Lilly’s Mounjaro (tirzepatide) for T2D patients. With respect to its safety profile, adverse events ranged from mild to moderate among subjects, and treatment discontinuation due to adverse events was 6.2%

Safety 105

Safety Patients Marketing Pharmaceutical 105

European Pharmaceutical Review

SEPTEMBER 13, 2024

Currently, treatment involves antibiotics , fluid resuscitation and vasopressors in addition to other supportive care for patients in septic shock, GlobalData explained. The 2017 WHA resolution stated that the condition “represents the most vital indication for the responsible use of effective antimicrobials for human health”.

Recruitment 52

Recruitment Safety Medicine Patients 52

Pharma Leaders

JUNE 7, 2023

This first randomised study has been designed to assess the safety and efficacy of the therapy versus daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd) to treat patients with relapsed or lenalidomide-refractory multiple myeloma.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

Side effects 104

Side effects Biopharma Patients Competition 104

World of DTC Marketing

AUGUST 12, 2022

In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV , cable , radio , and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. First, let’s clarify how the bill saves taxpayers billions.

Pharma 255

Pharma Retail Pharmaceutical Pharmaceutical manufacturing 255

pharmaphorum

DECEMBER 20, 2022

The filing is based on the 730-patient PRECISION trial , in which aprocitentan met its main objective of reducing systemic blood pressure compared to placebo, with an overall reduction of 3.8 “Patients with uncontrolled blood pressure are at risk of major cardiovascular events. It is thought that around 10% of the 1.3

Sales 92

Sales FDA Patients Safety 92

World of DTC Marketing

MAY 19, 2021

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S.

Pharma 181

Pharma Prescription Patients Pharmaceutical 181

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

JANUARY 27, 2023

However, Briumvi is unlikely to appeal to patients who are already receiving Genentech’s Ocrevus or Novartis’s Kesimpta. Briumvi is the third approved injectable MS treatment directed against CD20 antigen expressed on B cells, with the other therapies being Kesimpta (ofatumumab, approved in 2020) and Ocrevus (ocrelizumab, approved in 2017).

Marketing 52

Marketing Side effects Safety Patients 52

Pharmaceutical Technology

DECEMBER 21, 2022

The treatment is also indicated for patients who have failed or are not tolerant to other osteoporosis treatments available at present. The trial analysed the safety and efficacy of 80μg abaloparatide in men with osteoporosis.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

APRIL 18, 2023

The World Health Organization (WHO) designated carbapenem-resistant Acinetobacter baumannii as a priority pathogen for new antibiotic development in 2017. The drug had a favourable safety profile, including a statistically significant reduction in nephrotoxicity, based on the press release. Carbapenems are a class of antibiotics.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

World of DTC Marketing

DECEMBER 10, 2020

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Say goodbye to all the supposed goodwill.

Insurance 181

Insurance Pharma Manufacturing Retail 181

European Pharmaceutical Review

AUGUST 15, 2024

Second generation BTKi, acalabrutinib, was designed to be more specific against the target to mitigate some of the toxicities associated with ibrutinib and has demonstrated an improved safety profile in head-to-head clinical trial ELEVATE-RR (acalabrutinib vs ibrutinib) but with similar efficacy (non-inferiority trial with hazard ratio (HR)=1.0).

Safety 52

Safety Patients Medical Medicine 52

Legacy MEDSearch

SEPTEMBER 27, 2023

QT Medical aims to provide improved cardiac devices and services to revolutionize the care of patients with heart disease. Its flagship product, the Personal Cardiac Assistant (PCA 500) , is the only hospital-grade, resting 12-lead ECG device cleared by the FDA and CE marked for both professional and patient use.

Medical 52

Medical Recruitment Leads Management 52

pharmaphorum

JANUARY 3, 2023

” Rawlins was knighted in the 1999 Queen’s New Year Honours for services to the improvement of patient protection from the side effects of medicines, and in 2017 was appointed Knight Grand Cross of the Order of the British Empire (GBE) for services to the safety of medicines, healthcare, and innovation.

Side effects 52

Side effects Medicine Safety Healthcare 52

European Pharmaceutical Review

MAY 8, 2024

Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured non-engineered microbial strains isolated from healthy individuals.

Manufacturing 98

Manufacturing Safety FDA Patients 98

PM360

JUNE 26, 2023

In 2017, Algeria imposed importation restrictions on medicinal products that could be manufactured domestically, forcing manufacturers to establish local manufacturing facilities or to work with a contract manufacturing organization (CMO). To illustrate, let’s take the example of protectionist policies. References: 1.

Medicine 98

Medicine Marketing Pharma Manufacturing 98

Pharmaceutical Technology

JANUARY 23, 2023

However, this progress is not reflected with respect to approved treatments for paediatric IBD patients. Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients.

Medical 59

Medical Ethics Specialization Physicians 59

pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. Cutting down on safety stock. Here’s how applying automaton in pharmaceutical labs can help address these. Reducing capacity issues. Better communication with traceable data.

Pharma 103

Pharma Safety Pharmaceutical Manufacturing 103

pharmaphorum

JANUARY 5, 2023

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”.

Prescription 52

Prescription Specialization FDA Networking 52

Pharmaceutical Technology

MARCH 23, 2023

The agency reports that, in the pilot phase, these revisions halved the approval times for studies and cut the time from application to recruiting the first patient by 40 days. Between 2017 and 2021, the number of industry-led Phase III trials initiated fell by 48%, as per the report.

Healthcare 59

Healthcare Healthcare Recruitment Government 59

pharmaphorum

JANUARY 18, 2023

The ROSE2 study found that obicetrapib was able to reduce LDL cholesterol (LDL-c) levels when added to high-intensity statin therapy, raising the prospect that it could help patients struggling to manage their cholesterol levels with current drug therapy. Amgen licensed the rights to NewAmsterdam in 2020.

Pharma 59

Pharma Prospecting Patients Safety 59

European Pharmaceutical Review

DECEMBER 12, 2023

IPH5201 is being investigated in a Phase II trial, MATISSE, in combination with durvalumab (anti-PD-L1) and chemotherapy, in patients with resectable early-stage NSCLC. A favorable safety profile was also observed. Innate Pharma also developing IPH5201 in collaboration with AstraZeneca. An ORR of 46.4 percent in the blood.

Pharma 124

Pharma Engineering Safety Patients 124

Pharmaceutical Technology

JUNE 9, 2023

On 31 May, the FDA also approved Pfizer’s vaccine Abrysvo in the same patient population. AstraZeneca and Sanofi have been involved in the development and commercialisation of the drug since 2017. Still, Jackson added she felt comfortable about available safety and pharmacokinetic information. However, Dr.

FDA 59

FDA Food and Drug Administration Patients Food 59

pharmaphorum

OCTOBER 18, 2022

US-based Tempus has built a precision medicine platform – powered by artificial intelligence and machine learning – that sifts through a large library of anonymised patient data, including results of clinical, molecular, and genomic testing.

Pharma 52

Pharma Recruitment Patients Networking 52

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

FDA 84

FDA Doctors Patients Prescription 84

Pharmaceutical Technology

FEBRUARY 10, 2023

These agreements are either finance-based (with specified budget caps, discounts, or restrictions for a particular patient or disease population) or performance-based (with a specified endpoint or definition of response that determines whether the payor will cover the treatment on an ex post facto basis).

Marketing 105

Marketing Medicine Leads Pharmaceutical 105

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

Clarivate

MAY 11, 2023

Mainland China has streamlined regulatory protocols for testing and approving prescription drugs in recent years, making dozens of urgently needed treatments, from domestic and international manufacturers alike, available to patients in the process. CDE also released guidelines on Clinical trial requirements for overseas drugs.

Marketing 52

Marketing Patients Management Insurance 52

Pharma Marketing Network

MARCH 25, 2022

Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny White.

Pharma 98

Pharma Education Training Transportation 98

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. However, side effects do happen.

Management 77

Management Side effects Patients Safety 77

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.

Side effects 52

Side effects Leads Safety Patients 52

pharmaphorum

DECEMBER 6, 2022

Trial sites monitor patients participating in a research programme and enter their data into an electronic health record (EHR) for storage before transferring it to the trial’s electronic data capture (EDC) system. Only 5% of cancer patients have access to clinical trials. Today, Peleg explains, much of this process remains manual.

Electronics 98

Electronics Patients Medical Marketing 98

Legacy MEDSearch

AUGUST 25, 2022

The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow 0, 1, and 2 within 12 hours of symptom onset. The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days.

Medical 52

Medical FDA Recruitment Pharmacology 52