Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries. The funding will support the new production plant and distribution hub, which is aimed at enhancing access to high-quality medicines in Africa.

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Bio Pharma Dive

JUNE 6, 2023

The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.

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Bio Pharma Dive

JUNE 2, 2023

Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.

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Pharmaceutical Technology

JUNE 6, 2023

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 7, 2023

Dr K Sujith Kumar, the senior deputy drugs controller (DDC) at the department of drugs control administration (DCA) in Kerala has been appointed as the drug controller-in-charge of the state from Thursday, June, 1. A Ph D holder in Pharmaceutical Regulatory Affairs (PRA) from the JSS University in Mysore, Dr.

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Rethinking Clinical Trials

JUNE 8, 2023

The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 2023 Real World Data Scholars Program. This program supports the development of advanced graduate students, postdoctoral fellows, and early-career faculty who are interested in developing their expertise and experience in working with electronic health record (EHR) data.

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Bio Pharma Dive

JUNE 1, 2023

The biotech will price its biosimilar Yusimry at 85% below Humira’s list price when it launches next month, and charge even less if bought through Mark Cuban’s pharmacy.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 5, 2023

The “dissociative anesthetic” ketamine looks ever more promising as a safe and effective treatment for intractable depression. A new randomized trial from researchers in the United States has shown that injections of ketamine are at least as effective as electroconvulsive therapy (ECT) when treating non-psychotic forms of major depression.

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Rethinking Clinical Trials

JUNE 7, 2023

Dr. Shirley Wang In this Friday’s PCT Grand Rounds, Shirley Wang of Harvard Medical School will present “Emulating Randomized Clinical Trials With Non-randomized Real-World Evidence Studies: Results From the RCT DUPLICATE Initiative.” The Grand Rounds session will be held on Friday, June 9, 2023, at 1:00 pm eastern. The DUPLICATE initiative is building an empirical evidence base for using longitudinal insurance claims prospectively to achieve large-scale replication of randomiz

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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.

Clinical Research

Fierce Pharma

JUNE 4, 2023

AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. | AstraZeneca and Daiichi Sankyo’s Enhertu has already made waves in breast cancer treatment. Now, the companies are positioning the HER2 antibody-drug conjugate for expansion into other tumor types with data that researchers view as very compelling.

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Bio Pharma Dive

JUNE 5, 2023

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 7, 2023

Researchers have recently shown that separate mechanisms drive the hallucinogenic and antidepressant effects of psychedelics like LSD and psilocin, potentially paving the way to use these ‘party drugs’ as treatments that don’t trigger psychedelic trips.

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Rethinking Clinical Trials

JUNE 6, 2023

In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co-principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE Demonstration Project , shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the future of healthcare, and reflected on the impact the NIH Collaboratory has had on their trials thus far.

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Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Fierce Pharma

JUNE 3, 2023

The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor. | The rising antibody-drug conjugate class has hit a setback as Seagen’s Adcetris, one of the earliest and fast-growing members of the group, was defeated by immune checkpoint inhibitor in classical Hodgkin lymphoma.

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Pharmaceutical Technology

JUNE 5, 2023

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2023

A pill has been shown to halve the risk of death from a certain type of lung cancer when taken daily after surgery to remove the tumor, according to clinical trial results presented on Sunday.

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Outsourcing Pharma

JUNE 6, 2023

Research has reinforced the efficacy of Lumakras (sotorasib), a small molecule inhibitor in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).

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Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales

Fierce Pharma

JUNE 7, 2023

The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. | The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. On Wednesday, the government unveiled a two-year pilot program that will allow Novo Nordisk’s Wegovy to be given to more overweight participants, even though the treatment has yet to be launched there.

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Bio Pharma Dive

JUNE 5, 2023

The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.

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Pharmaceutical Technology

JUNE 4, 2023

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Viral vectors.

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ProRelix Research

JUNE 6, 2023

Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases. However, […] The post Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019 appeared first on ProRelix Research.

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XTalks

JUNE 6, 2023

The digital age has brought us an array of novel concepts, trends and terminologies, adding a fresh zest to our everyday lexicon. One such recent phenomenon making waves on social media is water recipes. This term might initially baffle those unacquainted with the trend, but it’s relatively simple and straightforward. Water recipes refer to a variety of methods to enhance plain water by adding flavorings, typically sugar-free syrups, powdered flavorings or a combination of the two.

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Fierce Pharma

JUNE 1, 2023

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit. | The drug is now approved to treat BRCA-mutated metastatic castration-resistant prostate cancer in combination with Johnson & Johnson’s Zytiga and a corticosteroid.

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Bio Pharma Dive

JUNE 6, 2023

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

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Pharmaceutical Technology

JUNE 4, 2023

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on on Innovation in Pharmaceuticals: Transcription facto

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Outsourcing Pharma

JUNE 6, 2023

The development of small molecule antivirals that target viral RNA in Henipaviruses will benefit from a $1.7million grant from Open Philanthropy, a philanthropic funder prioritizing global health and wellbeing.

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XTalks

JUNE 6, 2023

Prostate cancer stands as the second leading cause of cancer death among American men. Its early detection enhances the likelihood of survival, and survival is greatly influenced by the type and localization of the cancer. As a result, there is a constant demand for highly specific molecular imaging technologies. Recently, Blue Earth Diagnostics announced that the US Food and Drug Administration (FDA) has granted approval to its novel, high-affinity radiohybrid prostate-specific membrane antigen

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Fierce Pharma

JUNE 6, 2023

The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-se | The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-selling pharmaceuticals.

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Bio Pharma Dive

JUNE 5, 2023

Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.

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Pharmaceutical Technology

JUNE 2, 2023

The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody.

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Antidote

JUNE 5, 2023

Hunter’s disease, also known as Hunter syndrome or MPS II, is an inherited disease that impacts the X chromosome. Though it is a rare condition, it is one that can significantly impact children and their families. Currently, there is no known cure for Hunter syndrome , but there are ways that care providers can help diagnosed individuals manage their symptoms.

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