European Pharmaceutical Review

JUNE 19, 2023

A novel oral ‘robotic pill’ demonstrated a high success rate of drug delivery , according to clinical trial data presented at the Endocrine Society ’s annual meeting (ENDO 2023). “We believe this study provides the first clinical evidence of safe and successful delivery of the osteoporosis drug teriparatide through an oral robotic pill,” stated Arvinder Dhalla, Vice President of Clinical Development at Rani Therapeutics, which was the company that developed the technology.

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Fierce Pharma

JUNE 22, 2023

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

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Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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MedCity News

JUNE 19, 2023

One health system that initiated a journey mapping process for breast health services focused on connecting patients with a breast surgeon within 48 hours. But for the patient, that’s not 48 hours. That’s 10,000 moments of terror, she told them. Understanding this, the health system redesigned how it communicated with patients.

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European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with establ

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Fierce Pharma

JUNE 20, 2023

Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.

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MedCity News

JUNE 20, 2023

HC3 recently warned healthcare providers about a “relatively unknown” ransomware gang named TimisoaraHackerTeam. The group leverages legitimate software tools like Microsoft’s BitLocker and Jetico’s BestCrypt to deliver its malware.

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European Pharmaceutical Review

JUNE 23, 2023

Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.

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Fierce Pharma

JUNE 20, 2023

Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said.

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Pharmaceutical Technology

JUNE 23, 2023

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

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Patients

MedCity News

JUNE 23, 2023

The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.

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European Pharmaceutical Review

JUNE 23, 2023

The first gene therapy has been approved for certain patients from four to five years old with Duchenne muscular dystrophy (DMD). Elevidys has been authorised by the US Food and Drug Administration (FDA) for individuals with a confirmed mutation in the DMD gene without a pre-existing medical reason preventing treatment with this therapy. “Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy,” reported Dr Peter M

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Fierce Pharma

JUNE 20, 2023

After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

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Copyright Clearance Center

JUNE 20, 2023

The post The Role of Artificial Intelligence and Related Technologies in Academic Publishing and How it Might Transform the Way Publishers Work appeared first on Copyright Clearance Center.

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European Pharmaceutical Review

JUNE 21, 2023

this is the first real-time mass spectrometry approach using EI for compound ionisation” Researchers have reported that extractive-liquid sampling electron ionisation-mass spectrometry (E-LEI-MS) is a real-time, environmentally friendly approach that ensures a fast and reliable analytes identification. The paper proposed an analytical technique that combines the advantage of ambient sampling with the high identification power provided by electron ionisation (EI).

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Fierce Pharma

JUNE 22, 2023

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

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Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). Hemgenix is the first and only gene therapy approved for haemophilia B. At $3.5m per dose, it is the most expensive single-use gene therapy in the US. The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Clarivate

JUNE 19, 2023

Our latest Global Research Report from the Institute for Scientific Information (ISI) , Unpacking research profiles: Moving beyond metrics , is our second report to guide policy makers and research managers on the value of shifting from a reliance on simplistic metrics of research activity and performance towards an adoption of more visually informative profiles.

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European Pharmaceutical Review

JUNE 22, 2023

A study published in Pharmaceutics has illustrated the superior sensitivity of mechanistic compartmental analysis for nanomedicines. The paper described how both techniques were applied to two small molecule, nanomaterial-based formulations for intravenous injection: albumin-stabilised rifabutin nanoparticles and rifabutin-loaded PLGA nanoparticles.

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Fierce Pharma

JUNE 20, 2023

Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix. | Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.

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Legacy MEDSearch

JUNE 20, 2023

When did you first offer flexible work policies? What led your organization to implement a flexible work environment? For almost a decade, our company has been at the forefront of embracing work from home flexibility. We recognized the importance of accommodating our exceptional team members at all stages of their lives. By providing the option to work from home, we aimed to alleviate the traditional barriers and challenges associated with a fixed office-based environment.

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European Pharmaceutical Review

JUNE 20, 2023

Phase I study data of a first-in-class oral small molecule lactate dehydrogenase A (LDHA) inhibitor demonstrated successful use of a novel 13 C 2 -glycolate tracer. Data successfully demonstrates hepatic LDH target engagement in healthy volunteers and establishes proof-of-mechanism for CHK-336 to decrease hepatic oxalate production” The data presented at the 2023 European Renal Association (ERA) Congress “successfully demonstrates hepatic LDH target engagement in healthy volunteers

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Fierce Pharma

JUNE 20, 2023

When Sanofi made an asset swap with Boehringer Ingelheim in 2016, the French company acquired BI’s healthcare business, which included heartburn medicine Zantac. | An International Chamber of Commerce arbitration tribunal has sided with Sanofi, rejecting Boehringer Ingelheim's attempt to receive liability protections for cancer claims in the United States tied to heartburn medicine Zantac.

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Pharmaceutical Technology

JUNE 19, 2023

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. The pharma company will in-license a small number of gene therapy products and offer research grants to advance them through pre-clinical development. Laurus Labs will be responsible for launching these products in India and emerging markets.

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MedCity News

JUNE 19, 2023

As the industry focuses on creating a more holistic, inclusive experience, these three focus areas can help bridge the gap between patient, site, and clinical research administrators and help to modernize the clinical trial experience for all.

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European Pharmaceutical Review

JUNE 22, 2023

On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety. Combatting AMR calls for international cooperation based on the One Health Approach. 1 Adopting both the Antibiotic Manufacturing Standard and certification will help to “mitigate the risk of the deve

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Fierce Pharma

JUNE 22, 2023

The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 and older—in consultation with their doctors—receive vacc | The CDC's Advisory Committee on Immunization Practices has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus.

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PharmaVoice

JUNE 22, 2023

These six Big Pharma companies have ranked among the best places to work for LGTBQ+ equality by the Human Rights Campaign Foundation for over 10 years. Here’s why.

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