European Pharmaceutical Review

JULY 18, 2022

Phase III results from the explorer7 study presented at ISTH 2022 in London, UK, revealed an 86 percent reduction in treated spontaneous and traumatic bleeds for haemophilia A or B patients with inhibitors on concizumab prophylaxis. Dosing in the Phase III study is expected to start in the fourth quarter of 2022. compared to 11.8

Safety 98

Safety Patients Leads Medical 98

European Pharmaceutical Review

JULY 26, 2022

Under exceptional circumstances Nulibry * (fosdenopterin) was given a positive opinion for the treatment of molybdenum cofactor deficiency type A, an ultra-rare condition that appears shortly after birth and leads to brain injury and death. This product was designated as an orphan medicine during its development.

Medicine 105

Medicine Marketing Patients Safety 105

Pharma Pathway

DECEMBER 5, 2022

Walk-In Drive for Multiple Positions in M.Sc/ M.Pharma/ B.Tech/ M.Tech/ B.Sc / Diploma On 11th Dec’ 2022. Our culture of scientific innovation is driven by the expertise of our highly qualified team of 5,000 employees and supported by state-of-the-art infrastructure and market- leading technology. Syngene International Ltd.-Walk-In

Electronics 80

Electronics Specialization Engineering Management 80

PM360

DECEMBER 14, 2022

Aaron Martin, Amazon’s Vice President of Healthcare explained during the HLTH conference 2022 that: “It’s going to be partnership-focused and enable our audience, the folks who are using Amazon.com, to find, discover, and get access to some really awesome, innovative new technologies that might help them.”.

Manufacturing 52

Manufacturing Medical Healthcare Healthcare 52

PM360

AUGUST 9, 2022

Data from brief medication questionnaires can lead to overestimated adherence, given the info is self-reported, but can also result in valuable insights regarding attitude, barriers, influence, and other behavioral attributes. Adherence can be measured in a variety of ways, including electronic monitors.

Medical 105

Medical Patients Electronics Healthcare 105

European Pharmaceutical Review

JANUARY 22, 2024

Market growth factors Pharmaceutical extractable and leachable (E&L) testing services The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety , such as when mitigating cross-contamination risks, the report highlighted. percent in 2022.

Marketing 52

Marketing Safety Medicine Pharmaceutical 52

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Read on to for insights from our analysts on: Global highlights from ESMO 2022. Key ESMO 2022 highlights from Mainland China. Seven global highlights from ESMO 2022.

Marketing 52

Marketing Safety Patients Competition 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

This week, at the European Society of Medical Oncology (ESMO) Congress 2022 researchers presented encouraging updates on immunotherapies in the field of cervical cancer. A phase II study of GX-188E, combined with Keytruda, also explored the safety and effectiveness of treatments in PD-L1+ and PD-L1-negative cervical cancer patients. .

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 59

Impetus Digital

JUNE 8, 2022

Many people believe that this new development will lead to much better treatments, saving time on trial-and-error testing procedures before determining what works best for each patient’s unique health needs. This streamlined process could lead to swifter approvals of effective treatments, which would be a huge win for patients.

Medicine 52

Medicine FDA Leads Distribution 52

European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. With the data having been collected in a real-world (RW) setting during the 2022-2023 RSV season, it was “gathered at a time when RSV was recovering from the dip in case numbers during COVID lockdown” Professor Openshaw added.

Safety 104

Safety Leads Manufacturing Medicine 104

Spotio

MAY 18, 2022

Sales canvassing is when you initiate contact with a prospect or lead that you don’t have an appointment set or meeting scheduled with. I prefer to see getting leads while canvassing as a blend of art and science. So, with heightened awareness in combination with the following canvassing tips you can get more leads while canvassing: 1.

Sales 52

Sales Prospecting CRM Leads 52

European Pharmaceutical Review

JUNE 10, 2024

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). Roche released three-year data from the SUNFISH study in March 2022.

Safety 98

Safety Patients Leads Medical 98

European Pharmaceutical Review

JUNE 5, 2024

The company confirmed that Jemperli (dostarlimab-gxly)’s safety and tolerability was “generally consistent” with the agent’s existing profile. These long-term results build on data first presented at the 2022 ASCO Annual Meeting and published in The New England Journal of Medicine. months was observed”.

Safety 98

Safety Patients Manufacturing Medicine 98

European Pharmaceutical Review

MARCH 9, 2023

There are emerging trends in oncology, with new chemical entities (NCEs) and antibody-drug conjugates (ADC) leading to increased demand for HPAPI manufacturing capabilities. It’s a collaborative approach from safety, engineering, toxicology, and operations to have the most robust potent compound safety.

Safety 98

Safety Pharmacology Training Manufacturing 98

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. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

JUNE 15, 2023

However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. This microbial contamination can lead to a range of adverse events, such as infections, adverse reactions, or device failures, which can compromise patient safety and health outcomes.

Manufacturing 103

Manufacturing Medical Safety Transportation 103

PM360

OCTOBER 24, 2022

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world with its medicines, and is developing a pipeline of innovative medicines. Amgen also offers a training curriculum to prepare new managers to lead and inspire their teams.

Pharma 40

Pharma Medicine Education Manufacturing 40

European Pharmaceutical Review

SEPTEMBER 20, 2022

Over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable,” commented EMA’s Executive Director, Emer Cooke. This was substantiated by safety data of over one million patient-treatment years.

Medicine 98

Medicine Side effects Safety Doctors 98

Pharmaceutical Technology

AUGUST 17, 2022

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. The Verdict. Northgate Technologies Inc.

Training 98

Training Safety Medical Media 98

European Pharmaceutical Review

NOVEMBER 1, 2023

In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. It is one of the leading causes of death associated with AMR globally. 2022 [cited May2023]. The Lancet.

Safety 115

Safety Marketing Manufacturing Leads 115

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. First bispecific antibody approved in EU to combat leading causes of vision loss.

Manufacturing 104

Manufacturing Marketing Medicine Leads 104

European Pharmaceutical Review

MAY 4, 2023

The agency’s approval is important, because according to the US Centers for Disease Control and Prevention, RSV leads to around 60,000-120,000 hospitalisations and 6,000-10,000 deaths in adults 65 years of age and older every year in the US. percent and reduced the risk of developing severe RSV-associated LRTD by 94.1 percent.

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

Pharmaceutical Technology

MAY 23, 2023

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved. Extra doses of ORLADEYO above 150mg once daily are not suggested as this could lead to prolongation of the QT [a measure of the heart’s electrical activity].

Marketing 52

Marketing Biopharma Safety Patients 52

Pharmaceutical Technology

JUNE 19, 2023

In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology. Myelofibrosis is a rare bone marrow cancer that causes the dysfunctional production of blood cells, leading to extensive bone marrow scarring, causing severe anaemia. The reason for this review extension was undisclosed in the announcement.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

DECEMBER 16, 2022

The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. The primary endpoint in the pivotal HOPE-B study was 52-week ABR after achievement of stable FIX expression compared with the six-month lead-in period. Safety data from the haemophilia B Phase III trial.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Leads 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). 2022; 10(1). 2022; 24(2): 89 – 97. References 1. Garrido P et al. cited 2023Apr].

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

AUGUST 7, 2023

“We believe that this investment fits strategically with our long-term vision of expanding our capability in immuno-oncology and will ultimately lead to the development of new therapeutics for patients in need of cancer immunotherapy,” commented Adam Pearson, Chief Strategy Officer of Astellas.

Pharma 98

Pharma Safety Leads Pharmaceutical 98

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.

Safety 111

Safety Electronics Recruitment Patients 111

pharmaphorum

NOVEMBER 27, 2022

Incidents such as the hormone replacement therapy drug shortage in early 2022 have shown the damaging impact supply chain issues can have on people who depend on these drugs. Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication.

Pharma 103

Pharma Safety Pharmaceutical Manufacturing 103

European Pharmaceutical Review

SEPTEMBER 12, 2024

In 2022, Xenpozyme ® (olipudase alfa) became the first and only approved ASMD therapy. These gradually accumulate over time in organs such as the liver, spleen and lungs, leading to debilitating and life-threatening complications. What should the industry focus on to advance development of these treatments?

Safety 52

Safety Leads Patients Recruitment 52

European Pharmaceutical Review

OCTOBER 5, 2022

An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers. However, when it comes to pharmaceutical products, health and safety remains the primary consideration.

Pharma 98

Pharma Safety Pharmaceutical Manufacturing 98

European Pharmaceutical Review

JANUARY 17, 2023

“CER001 was significantly able to scavenge endotoxins, modulate the cytokine storm, and provide endothelial protection,” stated Professor Loreto Gesualdo, Head of the Nephrology, Dialysis and Transplantation Unit, University of Bari Aldo Moro, Italy, and lead investigator of the RACERS study. Trends showed improved 30-day survival.

Patients 98

Patients Safety Pharma Medicine 98

European Pharmaceutical Review

JULY 5, 2022

It can lead to painful attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The SPRING study trial results were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022. .

Safety 98

Safety Patients Leads Pharmaceutical 98

Pharmaceutical Technology

APRIL 6, 2023

Singapore has therefore become the second country to accept the NDA, following mainland China in November 2022. Leading with Nefecon as our anchor product, we are building a pipeline of promising renal drug candidates to address huge unmet medical needs.” Nefecon expects to secure NDA approval in Singapore this year.

Food and Drug Administration 52

Food and Drug Administration Food Medicine Safety 52

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. This could lead to significant research waste. 2022 Jan;56:8-14. References Attwood D, Curley A, Keenan E, Murphy S. Pain Management.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications.

Safety 95

Safety Patients Medical FDA 95

Pharmaceutical Technology

JUNE 15, 2023

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. At safety follow-up versus end of treatment, the six patients who responded to treatment had a 5.83% decrease in ppFEV1.

Safety 98

Safety Patients Marketing Leads 98