Fierce Pharma

SEPTEMBER 20, 2023

With the surge in demand for GLP-1 diabetes and weight loss drugs—and companies struggling to supply them—it was only a matter of time before knockoffs reached the market. | Early this summer, Novo Nordisk filed multiple lawsuits accusing companies of producing and selling compounded versions of Ozempic and Wegovy. Now, Eli Lilly has done the same, filing eight separate complaints in five states.

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Marketing 259

MedCity News

SEPTEMBER 20, 2023

ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.

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Fierce Pharma

SEPTEMBER 20, 2023

After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.

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Manufacturing FDA Medicine 247

MedCity News

SEPTEMBER 20, 2023

In the realm of pharmaceuticals, where innovation can be the difference between life and death, the emergence of generative AI, has been nothing short of transformative. Generative AI, powered by advanced machine learning algorithms, is rapidly reshaping the landscape of drug discovery, development, and optimization. By harnessing the capabilities of AI, the pharmaceutical industry is unlocking novel possibilities that were once deemed unattainable.

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Fierce Pharma

SEPTEMBER 20, 2023

Positive FDA advisory committee votes aren’t always a blueprint for approval. | Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.

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Medgadget

SEPTEMBER 20, 2023

Researchers at the Terasaki Institute in Los Angeles have developed a new method to create 3D printed muscle constructs with enhanced muscle cell alignment and maturation. The technique involves creating microparticles loaded with insulin-like growth factor (IGF) using a microfluidic platform. Then, these particles are included in a bioink that also incorporates myoblast cells and a gelatin-based hydrogel.

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MedCity News

SEPTEMBER 20, 2023

Gastroenterologist Dr. Austin Chiang has about a decade of experience as a physician influencer on social media. During a conference in Chicago, he encouraged more providers to share their expertise on social media. By having a presence on these platforms, healthcare professionals demonstrate their commitment to meeting patients where they are, he said.

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Pharmaceutical Technology

SEPTEMBER 20, 2023

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

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MedCity News

SEPTEMBER 20, 2023

The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.

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European Pharmaceutical Review

SEPTEMBER 20, 2023

Results of a Phase I/II study has revealed that a booster dose of a novel, self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine induces a robust, broadly cross-reactive, and durable immune response in adults. Three sa-mRNA vaccines used in the clinical trial enabled participants to maintain elevated immune response through 12 months post-vaccination.

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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.

Safety

Medgadget

SEPTEMBER 20, 2023

Researchers at RMIT in Australia have developed a drug-free approach to kill bacteria and fungi that can infect surfaces on medical implants. Such pathogens can cause serious and difficult-to-treat infections around medical implants, sometimes requiring the removal of the implant. In addition, many microbes are increasingly resistant to common antibiotics, highlighting the need for drug-free approaches.

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Pharmaceutical Technology

SEPTEMBER 20, 2023

Merck KGaA announced plans to join forces with BenevolentAI and Exscientia to leverage their AI-driven drug discovery platforms.

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PharmaTimes

SEPTEMBER 20, 2023

Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants - News - PharmaTimes

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MedCity News

SEPTEMBER 20, 2023

Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.

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Patients 109

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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PharmaTimes

SEPTEMBER 20, 2023

The universal vaccine could protect people against more strains of flu - News - PharmaTimes

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Pharma Marketing Network

SEPTEMBER 20, 2023

Pharma companies are highly matrixed organizations, which presents challenges in handoffs, overlaps between roles and functions, access to data and accountability of who owns and acts on this data in a timely manner. Therefore, instigating change at an organizational level is difficult, and takes much longer than anticipated. This podcast will share insights and experiences from Ozgun Demir, Head of Digital Marketing at Genentech on: Change management, resource management: how you ready the orga

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PharmaVoice

SEPTEMBER 20, 2023

The saga of the anti-parasitic drug continues.

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PharmaTech

SEPTEMBER 20, 2023

A common obstacle life sciences organizations face during clinical trials is obtaining the right patients and promoting consistent engagement. High-quality data and technology can be used to streamline clinical trials and enable omnichannel experiences.

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Patients 52

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Safety

PM360

SEPTEMBER 20, 2023

The American Federation for Aging Research (AFAR), a leading national non-profit organization whose mission is to support and advance healthy aging through biomedical research, has selected FINN Partners , a global full-service marketing and communications agency, to support its national campaign to recruit people age 95 or older and their adult children into a multi-year study investigating factors that contribute to healthy aging.

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PharmaTech

SEPTEMBER 20, 2023

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

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Manufacturing 52

Legacy MEDSearch

SEPTEMBER 20, 2023

SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. The intravascular imaging system combines next-generation DeepOCT images and near infrared spectroscopy (NIRS) with state-of-the-art ease of use to support physicians optimizing coronary stenting in the cardiac catheterization l

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Pharmaceutical Technology

SEPTEMBER 20, 2023

Pfizer has received marketing authorisation from the European Commission (EC) for LITFULO for the treatment of severe alopecia areata.

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Marketing 59

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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PharmaTech

SEPTEMBER 20, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

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FDA 52

Pharmaceutical Technology

SEPTEMBER 20, 2023

The FDA wanted changes to the Phase I/II study designs investigating TSHA-120 in the rare neurological disorder, giant axonal neuropathy.

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PharmaTech

SEPTEMBER 20, 2023

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

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Medicine 52

Pharmaceutical Technology

SEPTEMBER 20, 2023

BeiGene has signed an agreement with Novartis for regaining global rights related to the humanised IgG4 anti-PD-1 antibody, TEVIMBRA

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pharmacy Times

SEPTEMBER 20, 2023

Investigators of the GLAAD and Gilead COMPASS Initiative survey tracked the progress against HIV stigma, the transmission and prevention of HIV, and the attitudes and knowledge of those living with HIV in the United States.

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Pharmaceutical Technology

SEPTEMBER 20, 2023

The US Food and Drug Administration (FDA) has sNDA of Merck’s Welireg for advanced renal cell carcinoma and granted priority review.

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Food and Drug Administration FDA Food 52

Pharmacy Times

SEPTEMBER 20, 2023

Dapo Amosu, MS, PharmD, DPLA, discusses his thoughts on how to advance medication use processes in inpatient and ambulatory settings and the role of the pharmacist in this endeavor.

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Medical 55

Pharmaceutical Technology

SEPTEMBER 20, 2023

The US FDA requested an additional repeat-dose study to be completed before granting approval for the epinephrine nasal spray.

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FDA 52

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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