Pharmaceutical Technology

APRIL 24, 2023

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with cert

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Medicine Drugs Production Research 262

Bio Pharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

FDA Approval 352

FDA Approval Medicine Protein Marketing 352

Rethinking Clinical Trials

APRIL 24, 2023

An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern. Rosemarie Martin of Brown University and Linda Hurley of CODAC Behavioral Heathcare will report on a study of a systems-change approach for increasing

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Clinical Trials Clinical Trials Trials Research 189

STAT News

APRIL 24, 2023

A new book on the U.S. response to the Covid-19 pandemic paints a picture of a country ill-prepared to cope with a dangerous biological foe, riven by partisan politics, and led by people who saw little political gain in taking ownership of managing the crisis. It also describes a country that remains ill-equipped to battle the next pandemic or major disease threat, though it lays out changes that could strengthen the country’s position.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

APRIL 26, 2023

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Clinical Trials Clinical Trials Research Allergies 289

Bio Pharma Dive

APRIL 28, 2023

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

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Vaccination Vaccine 331

STAT News

APRIL 25, 2023

As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders

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Drugs 144

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Gene Therapy Drugs Gene Gene Editing 264

Bio Pharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

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Production Manufacturing Drugs 328

Medical Xpress

APRIL 28, 2023

Neuroscientists have uncovered how exploratory actions enable animals to learn their spatial environment more efficiently. Their findings could help build better AI agents that can learn faster and require less experience.

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Clinical Supply

Fierce Pharma

APRIL 24, 2023

Apellis hits setback in ALS trial after pair of pegcetacoplan approvals fkansteiner Mon, 04/24/2023 - 10:56

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Trials 134

Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

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Marketing Medicine Production Clinical Trials 264

Bio Pharma Dive

APRIL 26, 2023

Founded by Howard Chang, John Maraganore and others, the RNA-focused startup drew investment from a large group of blue-chip venture investment firms.

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RNA 323

Medical Xpress

APRIL 28, 2023

Northwestern Medicine scientists have discovered how octopamine, the major "fight-or-flight" neurotransmitter in invertebrates, communicates with other cells in mammalian brains to prevent cell death, according to a study published in the Proceedings of the National Academy of Sciences.

Scientist 137

Scientist Medicine Research 137

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Fierce Pharma

APRIL 26, 2023

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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Trials Drugs 133

Pharmaceutical Technology

APRIL 24, 2023

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this combination regimen for patients in the UK’s National Health Services.

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Drugs 246

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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FDA Approval Drugs Trials 321

Medical Xpress

APRIL 28, 2023

There has been widespread speculation about how advances in artificial intelligence (AI) assistants like ChatGPT could be used in medicine.

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Medicine 137

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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.

Clinical Trials

Fierce Pharma

APRIL 26, 2023

FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

FDA Approval 131

FDA Approval 131

Pharmaceutical Technology

APRIL 24, 2023

The Covid-19 pandemic pushed the healthcare industry toward rapid digitalisation, with the rise of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology now changing the way healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment for psychological and neurological disorders.

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Pharmacy Doctors Doctor Manufacturing 237

Bio Pharma Dive

APRIL 26, 2023

The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

FDA Approval 312

FDA Approval Drugs 312

Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

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Clinical Development Gene Therapy Development Gene 133

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

Rethinking Clinical Trials

APRIL 27, 2023

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “ Intervention Delivery and Complexity ,” illustrates that—although an intervention may be simple—the actual delivery of the intervention may be complex due to factors such as new workflows, special training of frontline staff, and the number of components in the intervention.

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Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

APRIL 28, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for use in older adults. The vaccine candidate will be used to prevent lower respiratory tract diseases (LRTD) caused by RSV in adult patients aged 60 and above. This is the first time a vaccine candidate for the potential treatment of adult RSV patients has received a positive opinion.

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Vaccination Vaccine Medicine Trials 162

Bio Pharma Dive

APRIL 28, 2023

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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Sales 306

Medical Xpress

APRIL 28, 2023

Gone are the days of dictatorial leaders in sport, screaming from the side-lines and insulting their players, and instead we are seeing an era of emotionally intelligent leaders who demonstrate an understanding of other people while getting effective results.

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Research 131

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Clinical Supply

Rethinking Clinical Trials

APRIL 26, 2023

In this Friday’s PCT Grand Rounds, Matthew Semler of Vanderbilt University will present “Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-Crossover Trial.” The Grand Rounds session will be held on Friday, April 28, 2023, at 1:00 pm eastern. Dr. Semler is an assistant professor of medicine and bioinformatics and the medical director of the Center for Learning Healthcare in the Vanderbilt Center for Clinical and Translation

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Trials Bioinformatics Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 24, 2023

Vallon Pharmaceuticals has concluded the previously announced merger of its operations with biotechnology firm GRI Bio. With work on the agreement, announced in December 2022 , now complete, the combined entity will operate under the brand of GRI Bio. It will support the further development of GRI Bio’s natural killer T (NKT) cell modulators pipeline, to treat inflammatory, fibrotic and autoimmune diseases.

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Branding Development Marketing 162

Bio Pharma Dive

APRIL 27, 2023

The cell and gene therapy developer will also cut back on manufacturing and certain research in California as it redirects resources to three priority programs.

Gene Therapy 278

Gene Therapy Gene Manufacturing Development 278

Medical Xpress

APRIL 27, 2023

Research led by Maynooth University and published today in the journal Science Signaling has found that the protein MYC is essential for MAIT cell growth, proliferation, metabolism and function. The latest findings are of critical importance to the study of MAIT cells and the development of metabolic disease such as obesity.

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Regulation Protein Development Research 130

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials