Pharmaceutical Technology

JUNE 2, 2023

The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU.

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European Pharmaceutical Review

OCTOBER 22, 2024

It follows a consultation with stakeholders in 2021, which resulted in great support for proposals for a framework focused on point of care and modular manufacturing. Introduction of this framework was originally announced by the MHRA in January 2023. Introduction of this framework was originally announced by the MHRA in January 2023.

Medicine 52

Medicine Manufacturing Safety Consulting 52

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

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World of DTC Marketing

AUGUST 12, 2022

In 2021 alone, the top U.S. The bill does not affect the list prices companies charge for new drugs, which increased from a median price of $2,115 in 2008 to a staggering $180,007 in 2021, according to recent research. He leads the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston.

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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.

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Pharma Safety Pharmaceutical Manufacturing 98

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed. 2021; 27 (2): S1-S21.

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European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed. However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise.

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Food and Drug Administration FDA Food Marketing 97

European Pharmaceutical Review

MAY 24, 2024

UCB has announced positive results from the first Phase III trials evaluating the efficacy and safety of an IL-17A and IL–17F inhibitor to treat adults with moderate-to-severe hidradenitis suppurativa. This medicine was authorised by the European Commission for plaque psoriasis in August 2021.

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Patients Medical Safety Medicine 98

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

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Food and Drug Administration Food Safety Patients 98

European Pharmaceutical Review

OCTOBER 9, 2023

A new approach to potassium-channel openers for epilepsy Critically, XEN1101 combines the effectiveness of potassium-channel openers with the safety of more traditional drugs, stated study lead author and neurologist Dr Jacqueline French. It ran between January 2019 and September 2021.

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Contrarian Sales Techniques

NOVEMBER 18, 2024

With platforms like Esyms and DoctorOnCall leading the way, Malaysians can now order prescription and over-the-counter medications online, and have them delivered directly to their homes. It’s all about convenience, safety, and accessibility, especially for those who may not have easy access to physical pharmacies. The Bottom Line?

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Medicine Pharma sales reps Safety Healthcare 40

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

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Patients Pharma Recruitment Distribution 52

European Pharmaceutical Review

APRIL 27, 2023

“This is the first time that we tested blinatumomab as a first-line treatment, and for the first time in such young children,” stated Dr Inge van der Sluis, study lead and paediatric oncologist and clinical pharmacologist at the Princess Máxima Center for paediatric oncology in the Netherlands.

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Pharmaceutical Technology

APRIL 14, 2023

The World Health Organization (WHO) says that in 2021, children under five years accounted for approximately 80% of malaria deaths in Africa, a continent disproportionately affected by the disease. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

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Manufacturing FDA Food Safety 111

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. These shocks can lead to unpredictable or even absent shipments, meaning drug production labs often aren’t dealing with a stable and regular volume of raw materials.

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Pharma Safety Pharmaceutical Manufacturing 103

European Pharmaceutical Review

JANUARY 18, 2023

She shared: “Respiratory diseases are a major public health priority given they… are a leading cause of hospitalisation.” The trial showed the mRNA vaccine was well tolerated with no safety concerns identified. Safety and tolerability will continue to be followed in this ongoing study.

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Safety Leads Pharmaceutical 105

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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Food and Drug Administration Safety Recruitment Medical 98

Clarivate

JULY 31, 2023

Following the acquisition of Dialog Solutions as part of the ProQuest M&A in December 2021, Dialog Solutions products and services will be folded into the Clarivate portfolio of offerings for Life Sciences & Healthcare. Today, the Dialog Solutions brand has been integrated into Clarivate.

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Healthcare Healthcare Safety Competition 52

pharmaphorum

AUGUST 19, 2022

The endorsement of the drug’s efficacy and safety comes at a good time for the Swedish biotech, just a month before the drug, known as Pepaxto in the US, will have its safety reviewed by an FDA advisory committee after being withdrawn from sale there last year.

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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).

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Healthcare Healthcare Safety Electronics 98

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.

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Pharmaceutical Technology

APRIL 28, 2023

This funding will enable us to accelerate the development of our lead antibody programme targeting inflammatory fibrin in neurodegenerative and retinal diseases. “We We look forward to advancing our first candidate, THN391, into clinical trials, and expect to announce key safety and proof of mechanism clinical data by the end of 2024.”

Safety 52

Safety Medicine Leads 52

Legacy MEDSearch

DECEMBER 5, 2022

The FDA clearance follows the CE mark already received by the product in May 2021. The WISE Cortical Strip performances have been successfully validated in a multicentric pre-market clinical study in Europe, the WIN study ( NCT03731455 ), that demonstrated safety, performance and usability of the product.

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FDA Recruitment Leads Medical 98

pharmaphorum

NOVEMBER 1, 2022

The results were based on pre-specified interim analysis conducted through an independent review committee and safety results were consistent with the safety profile previously demonstrated by Reblozyl in the MEDALIST study (NCT02631070). This can lead to anaemia and frequent or severe infections. in November 2021.

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Safety Patients Pharma Leads 52

European Pharmaceutical Review

NOVEMBER 10, 2022

With the new modalities used to treat disease and address previously undruggable targets, advanced drug delivery systems are critical to ensure targeted delivery, and to maximise safety and efficacy. Dr Isabel Peset is Lead Scientist – Advanced Microscopy, Medicines Discovery Catapult. Figure 1 ). About the authors.

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Curzon Consulting

NOVEMBER 15, 2021

15th November 2021 1 Minutes. Chetan Trivedi I lead Healthcare at Curzon Consulting. I am deeply passionate about improving health outcomes, safety and quality of life for patients. If hip and knee implant manufacturers want to stay relevant, and “move the needle” on value creation, they need to play big or go home!

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Manufacturing Consulting Healthcare Healthcare 52

European Pharmaceutical Review

NOVEMBER 1, 2023

It is one of the leading causes of death associated with AMR globally. Using this approach, our lead programme – RVX 001, a protein-based vaccine against invasive pneumococcal disease – has been designed with antigens common to all pneumococcus serotypes. Bacterial vaccines in clinical and preclinical development 2021 [Internet].

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Safety Marketing Manufacturing Leads 115

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

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Food and Drug Administration Manufacturing Safety Transportation 97

pharmaphorum

JANUARY 27, 2023

The decision comes after Ipsen was forced to withdraw its marketing application for palovarotene in the US in 2021, which delayed regulatory filings elsewhere, although the French pharma company has picked up an approval for the drug in Canada, where it is sold as Sohonos.

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European Pharmaceutical Review

AUGUST 15, 2024

1 The cancer is a slow-growing but potentially life-threatening B-cell malignancy, in which increased activation of B-cell receptor signalling pathways leads to overgrowth of lymphocytes in bone marrow and other disease compartments. for all-comers; HR=0.52 for all-comers; HR=0.52

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Safety Patients Medical Medicine 52

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, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

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Food and Drug Administration Safety Patients Medicine 98

pharmaphorum

NOVEMBER 24, 2022

The opportunity is open to academic, government, and industry organisations anywhere in the world, with a lead partner based in the UK. Dr Catherine Kettleborough, lead of the LifeArc Chronic Respiratory Infection Translational Challenge, said: “Repurposing an existing drug or compound is a faster way of getting new treatments to patients.

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Government Leads Medical Safety 59

European Pharmaceutical Review

NOVEMBER 11, 2022

The trial evaluated the safety, tolerability and efficacy of NTLA-2001 in 12 participants. The fibrils prevent ordinary organ function and can lead to progressive organ failure. These results indicate that IV NTLA-2001 is a potential new treatment option… However, further research is needed to establish [its] long-term safety.”.

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Safety Patients Medical Transportation 118

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.

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Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

OCTOBER 24, 2023

However, it also leads to a decline in the quality of life and the condition can be fatal. Therefore, the development of a drug that has a safety profile and can target the underlying causes of AD pathology to achieve a cure for AD has been an ongoing pursuit of researchers in this field. The process of Aβ aggregation.

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Leads Patients Networking Safety 103

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. 2021; 11(5): 355. 2011; 117(11): 2993–3001. Salvaris R, Ong J, Gregory GP.

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Engineering Food and Drug Administration Patients Safety 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.

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Pharmacology Engineering Consulting Leads 69