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

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

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

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 81

Recruitment Safety Medicine Patients 81

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

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 100

Management Side effects Patients Safety 100

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

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

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

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

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

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

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

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

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

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

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

MARCH 10, 2017

2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region.

Marketing 52

Marketing Competition Safety Pharma 52

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

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

European Pharmaceutical Review

DECEMBER 11, 2023

The first approved ASO was designed for injection directly into the eye for the local treatment of cytomegalovirus (CMV) retinitis in immunocompromised AIDS patients. mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years.

Safety 98

Safety Pharmacology Engineering Medical 98

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

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

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products.

Medical 117

Medical Government Marketing Medicine 117

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 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

Evolve Your Success

AUGUST 8, 2023

He also touches on the heartwarming moments he’s experienced, where his work directly impacted patients’ lives and contributed to their recovery. I’ve been in medical device for years starting in 2017. This is probably one of the biggest moments of that patient’s life. No complaints. My name is Alex Matthews.

Sales 130

Sales Medical Management Patients 130

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

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

Medgadget

MARCH 2, 2023

Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. The rest of the patients had partial responses.

Manufacturing 82

Manufacturing Leads Patients Medicine 82

Evolve Your Success

NOVEMBER 15, 2022

It’s because of what they have, hospitals and healthcare systems need to improve patient care. I was like, “I’m not interested in direct patient care as much as that part that comes alive in me, where I’m like, “How does the business side work?” It’s, How does that product serve patient care?

Medical sales 130

Medical sales Medical Sales Medical sales reps 130

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). In March 2023, the company announced the screening of the trial’s first patient.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. The voucher system marks another one of the EU’s steps against the rising threat of AMR announced in recent years.

Pharma 52

Pharma Pharmaceutical Government Marketing 52

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. New hope for stomach cancer patients.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

Patients 96

Patients Food and Drug Administration Side effects Food 96

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 105

Pharma Safety Pharmaceutical Manufacturing 105

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