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 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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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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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 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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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

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 20, 2023

Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.

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MedCity News

JUNE 22, 2023

While President Biden touts the recently negotiated deal to raise the debt ceiling as a “crisis averted,” the deal fails to address the increasingly complex needs of our vulnerable food insecure populations who rely on The Supplemental Nutrition Assistance Program (SNAP). Political theater aside, the entire back-and-forth with the debt ceiling reminds me of another – less politically correct – phrase.

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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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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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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

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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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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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 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 22, 2023

Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.

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PharmaTimes

JUNE 21, 2023

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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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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PharmaVoice

JUNE 20, 2023

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

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Safety

MedCity News

JUNE 20, 2023

In order to gain trust from communities, healthcare leaders will need more training on effective communication, said Dr. Vin Gupta, a pulmonologist and chief medical officer of Amazon Pharmacy. He made these comments last week during a panel at the AHIP 2023 conference in Portland.

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Medgadget

JUNE 19, 2023

Researchers at Rockefeller University have developed a cell culture platform in which to grow ‘lung buds’ from human embryonic stem cells. The tiny structures are similar to the lung buds that form during fetal development, and they contain tiny airways and alveoli. The researchers create the structures in a bio-reactor style device that is furnished with microfluidic chips in which the lung buds grow.

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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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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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