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

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 Electronics Patients Healthcare 105

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

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

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

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 79

Healthcare Healthcare Electronics Safety 79

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 88

Safety Pharmacology Training Manufacturing 88

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

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

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 95

Safety Marketing Manufacturing Government 95

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 87

Medicine Side effects Safety Doctors 87

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

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 Pharma 52

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 78

Manufacturing Medical Safety Transportation 78

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 102

Pharma Safety Pharmaceutical Manufacturing 102

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 89

Food and Drug Administration Safety Medicine Patients 89

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 82

Manufacturing Marketing Medicine Safety 82

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 83

Pharma Safety Leads Pharmaceutical 83

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

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

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 These actions occur at both the delivery site and other systemic locations, thereby promoting an immunogenic response that leads to cancer cell death. cited 2024Jan].

Food and Drug Administration 86

Food and Drug Administration Transportation FDA Medical 86

Pharmaceutical Technology

APRIL 28, 2023

The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. fetal haemoglobin after five months, per a December 2022 update. The first patient had a total haemoglobin level of 16.4 g/dL and 45.4% Editas has plans to dose 20 patients on this study by the end of this year.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

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 90

Safety Patients Leads Pharmaceutical 90

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. Cradle to grave. cited Dec2023].

Safety 110

Safety Medicine Competition Networking 110

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 82

Medical Food and Drug Administration Pharmacology Medicine 82

Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. In December 2022, the company presented data from the first two patients treated in the Phase I/II RUBY (NCT04853576) trial.

Food and Drug Administration 98

Food and Drug Administration Food Safety Patients 98

pharmaphorum

JANUARY 17, 2023

Angion Biomedica ended 2022 in the midst of a strategic review after its lead drug for kidney diseases flamed out, and it has now charted a path forward – a reverse merger with clinical-stage biotech Elicio Therapeutics.

Pharmacology 71

Pharmacology Engineering Consulting Leads 71

Pharma Pathway

FEBRUARY 6, 2023

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. We are hiring! syngeneintl.com For More Details. Double dose Vaccination certificate. •As Syngene International Ltd.

Specialization 81

Specialization Safety Manufacturing Medicine 81

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 75

Food and Drug Administration Manufacturing Safety Transportation 75

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US.

Marketing 105

Marketing Medicine Leads Safety 105

pharmaphorum

JUNE 29, 2022

Earlier this month, Pfizer filed a lawsuit (HP-2022-000016) in the Royal Courts of Justice in London, seeking to invalidate three GSK patients covering its RSVPreF3 shot, according to a report on the Law360.com For children younger than five years old in the US, the infection leads to approximately 2.1 com website.

Marketing 82

Marketing Leads Safety Sales 82

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Significance of Annex 1–2022 for implementing Pharma 4.0 One of these key technologies is automation, a recent paper explained. Tanzini et al.

Food and Drug Administration 69

Food and Drug Administration Manufacturing Pharma Pharmaceutical 69

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. However, there were some notable differences.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Medicine FDA 94

European Pharmaceutical Review

NOVEMBER 9, 2022

The trial investigated the efficacy and safety of 12 or 24 weeks of bepirovirsen treatment on stable NA treatment or not-on-NA treatment at study start. There were no safety signals to prevent further development. A loading dose of Bepirovirsen was given at day 4 and 11.

Safety 82

Safety Patients Medicine Leads 82

pharmaphorum

SEPTEMBER 11, 2022

Hard on the heels of a new $575 million partnership with GSK, US biotech SpringWorks Therapeutics has reported phase 3 data at ESMO that sets up regulatory filings for its lead drug nirogacestat in a rare and aggressive form of soft tissue cancer. Oncology (@myESMO) September 10, 2022. link] #rarecancer. — ESMO – Eur.

Side effects 52

Side effects Leads Safety Patients 52

European Pharmaceutical Review

SEPTEMBER 15, 2022

The long-term data analyses of the Phase III KEEPsAKE 1 and 2 trials also revealed no new observed safety signals through 100 weeks. ” Skyrizi was generally well-tolerated and no new safety signals were noted in both KEEPsAKE 1 and 2 at 100 weeks of treatment. Serious treatment-emergent adverse events (TEAEs) occurred at 7.6

Safety 67

Safety Physicians Patients Consulting 67

Pharmaceutical Technology

MARCH 20, 2023

Leading the race to commercialisation is Intercept Pharmaceuticals, which, in December 2022, resubmitted the new drug application (NDA) for its obeticholic acid (OCA), an FXR agonist, as a Class 2 resubmission (which has a six-month review period) for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH.

Marketing 52

Marketing FDA Leads Safety 52