PM360

OCTOBER 8, 2024

The company is the only pure-bred pharmacovigilance specialist, providing comprehensive, independent pharmacovigilance services as well as advanced tools and technology-powered solutions that address companies’ most complex product safety needs. It was a great honor to be approached to lead Qinecsa’s next important growth phase.

Leads 52

Leads Safety Biopharma Management 52

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 Medical Safety Media 98

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

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

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

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

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

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 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

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

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

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

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 93

Pharmacology Engineering Consulting Leads 93

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

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

pharmaphorum

SEPTEMBER 27, 2022

The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022. Initial phase 1/2a clinical findings for in CLL and multiple myeloma patients showed evidence of anti-tumour activity and an encouraging safety profile, with further readouts due before the end of the year.

Safety 111

Safety FDA Sales Leads 111

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

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

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

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

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 Leads CRM 52

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 98

Safety Patients Medicine Leads 98

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 Patients Safety 98

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. In clinical trials, the drug showed a 3.8-point point improvement (unadjusted means) and a 3.2-point

FDA 126

FDA Safety Pharmaceutical Patients 126

Pharmaceutical Technology

DECEMBER 11, 2022

The first subject was dosed in the trial, which is designed to evaluate the safety, tolerability and immunogenicity of a nucleoside-modified RNA-based combination vaccine approach. In November, the companies announced plans for a Phase I clinical trial of the combined vaccine candidate in healthy adult subjects.

FDA 115

FDA Food and Drug Administration Food Safety 115

European Pharmaceutical Review

MAY 8, 2024

Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the approval of the first two commercial donor-derived products, Rebyota and VOWST, in 2022 and 2023, respectively.

Manufacturing 98

Manufacturing Safety FDA Patients 98

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. The PATCH pivotal study will enroll up to 188 patients across the U.S.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

Sales 112

Sales Patients Medicine Biopharma 112

European Pharmaceutical Review

SEPTEMBER 20, 2022

Zuranolone was generally well-tolerated with a safety profile consistent with prior clinical studies. These results are part of 11 analyses being presented at the 2022 Psych Congress. Depression is a leading contributor of disability worldwide and importantly awareness has grown during the past few years of the global pandemic.

Patients 98

Patients Safety Leads Pharmaceutical 98

pharmaphorum

JANUARY 3, 2023

As December 2022 closed out, Pfizer announced positive top-line results from its phase 3 BENEGENE-2 study evaluating fidanacogene elaparvovec (SPK-9001), its investigational gene therapy for treatment of adult males with moderately severe to severe haemophilia B. during the lead-in pre-treatment period of at least six months.

Medicine 98

Medicine Engineering Safety FDA 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2022; 7(12):1083-1091. Lancet Gastroenterol Hepatol. J Clin Microbiol.

Safety 111

Safety Patients Side effects Management 111

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure.

Side effects 144

Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 2022; 21(1). Biotechnol. Dimitri A, Herbst F, Fraietta J. Mol Cancer. Tang A, Harding F.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 105

Ethics Medicine Education Competition 105

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. the enteric coating and the capsule dissolve. Diabetes Therapy.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105