European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. percent through 2027.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Pharmaceutical Technology

MAY 12, 2023

SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.

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PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We I’m excited to join Ardelis and lead the next phase of our growth,” said Garde.

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European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. What Influence the Future of the Large-Cap Pharma Industry?

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Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. This signifies the growth potential of marketed drugs in established marketplaces and the complexity of oncology treatment paradigms.

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European Pharmaceutical Review

JUNE 27, 2023

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Based on current innovations, “this is the era of personalised medicine,” according to Silber. coli strains in the gut”.

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Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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European Pharmaceutical Review

APRIL 21, 2023

2 A study found that pharmaceuticals and other chemical products are responsible for 40 percent of the Dutch healthcare system’s greenhouse gas emissions and about 80 percent of its share of material extraction. The environmental impact of the Dutch healthcare sector beyond climate change: an input-output analysis. 2022; 6: 949-57.

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Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Otsuka Medical Devices Co.,

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European Pharmaceutical Review

MARCH 2, 2023

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. Under current clinical practice, donor lungs are preserved and transported in an inflated state from donor to recipient site.

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Legacy MEDSearch

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Food and Drug Administration. Ancora Heart , Inc.,

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pharmaphorum

SEPTEMBER 28, 2022

NIH’s All of Us is building an extensive, diverse biomedical dataset to learn how biology, lifestyle, and environment affect one’s health, and to accelerate research and improve personalised medicine options. This dual approach will lead to better medical research that will benefit all populations.” Gathering data.

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

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World of DTC Marketing

MARCH 17, 2022

But it’s’ still the leading cause of cancer deaths. The cost of cancer medicines is unsustainable. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. American Cancer Society’s ACS ).

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pharmaphorum

JANUARY 30, 2023

This poses significant issues for healthcare systems in those countries, as those in the Northern Hemisphere are dealing with infectious diseases that commonly occur in winter. One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages.

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Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. We are going to be the change for healthcare because we are the boots on the ground and so are you. What drugs are we using? You do not even have to say it.

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pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. In April, the PREFER framework received a positive qualification from the European Medicines Agency (EMA).

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European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. Regulation, particularly Annex 1, was identified as a key focus for 2022. About the authors.

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European Pharmaceutical Review

OCTOBER 19, 2023

This has been instrumental in having the medical oncology community look at radiopharmaceuticals as alternative medicines for the treatment of late-stage cancers where they are available. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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pharmaphorum

OCTOBER 3, 2022

Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. It also would be in line with emerging markets’ ambitions to grant patients access to the latest, on-patent, innovative medicines. Lands of opportunity: Asia, Africa, and South America.

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European Pharmaceutical Review

APRIL 30, 2024

mRNA therapeutics: a limitless revolution in medicine Another important element is a strong emphasis on process analytical technology (PAT). For example, they will continue to mainly focus on one lead candidate, instead of working on multiple molecules in their pipeline.

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European Pharmaceutical Review

JUNE 28, 2022

According to the World Health Organization (WHO), CVDs are the leading cause of death worldwide accounting for 32 percent of global deaths in 2019 (approximately 17.9 2 The estimated annual healthcare costs associated with circulatory disease in the UK is £9 billion. Within the UK alone, an estimated 7.6

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Impetus Digital

NOVEMBER 14, 2022

We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Socioeconomic and racial disparities in healthcare are widely acknowledged. Online collaboration and co-creation.

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Evolve Your Success

FEBRUARY 7, 2023

He discusses why the future of the healthcare industry in the United States lies not in hospital buildings but in surgery centers. Some people in medicine get to the point where they don’t want to chase doctors around anymore. One in insurance, retail and healthcare that is still around. I won eight President’s Clubs.

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Cadensee

JULY 20, 2021

02:25 Uri Goren talks about his road to become a trailblazer and advocate for patient-centric healthcare. 52:21 Uri's opinion about the main problem that needs to be solved for the healthcare market with technology. It might be silly question but bringing a drug to market takes many, many years. And it's shifting the power.

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Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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