Sat.May 06, 2023 - Fri.May 12, 2023

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Eli Lilly damages tripled to $184M in Medicaid rebate fraud case

Fierce Pharma

Eli Lilly damages tripled to $184M in Medicaid rebate fraud case fkansteiner Wed, 05/10/2023 - 10:25

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B2B Sales Prospecting: What You Need To Know

Spotio

Business-to-business (B2B) prospecting is the pillar of lead generation. When prospecting for new business, the goal is to identify as many quality prospects as possible. However, B2B sales prospecting strategy is not as easy as it sounds. According to Technology Advice , 70% of marketers at B2B companies reported that “improving lead quality” was the primary concern.

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Optimized for Growth? Revenue Management in Pharma

PharmExec

According to the latest State of Revenue survey of c-suite executives, pharma manufacturers are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

Pharma 96
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

Patients 138
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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Sanofi, AstraZeneca strengthen case for RSV antibody with data from real-world trial

Fierce Pharma

Sanofi, AstraZeneca strengthen case for RSV antibody with data from real-world trial kdunleavy Thu, 05/11/2023 - 15:23

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Medicare Improperly Paid Providers $348M for Telehealth Psychotherapy Services

MedCity News

Out of the $1 billion in Medicare payments to providers for psychotherapy services in the first year of Covid-19, $580 million were improper payments, an audit by the Office of Inspector General found. This includes $348 million for telehealth services.

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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As pharma fights IRA, Senate moves forward basket of bills aimed at lower drug prices

Fierce Pharma

As pharma fights IRA, Senate moves forward basket of bills aimed at lower drug prices aliu Fri, 05/12/2023 - 10:48

Pharma 299
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Is ChatGPT Healthcare’s Autopilot?

MedCity News

While human empathy will never be replaced, AI technologies and ChatGPT are providing new possibilities to help healthcare providers engage more efficiently with their patients and streamline administrative duties so physicians can focus more on their patients.

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Implanted Ultrasound Lets Chemo Access Brain

Medgadget

Researchers at Northwestern University have trailed an implanted ultrasound device in patients, which is used in combination with microbubbles to transiently open pores in the blood brain barrier, allowing chemo drugs to enter. We have reported on this technique before as a lab-based concept (see flashbacks below), but this is the first time that it has actually been trialed in human patients, in this case patients with glioblastoma, a difficult to treat brain cancer.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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$1.7b acquisition to develop rare haematology therapy

European Pharmaceutical Review

Swedish Orphan Biovitrum AB (Sobi ® ) has agreed to acquire CTI BioPharma for $1.7 billion, with the intention to advance an oral kinase inhibitor treatment for the rare disease myelofibrosis. Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma

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After Shkreli's run in with the law, Pharma Bro's former company Vyera files for bankruptcy

Fierce Pharma

After Shkreli's run in with the law, Pharma Bro's former company Vyera files for bankruptcy fkansteiner Thu, 05/11/2023 - 11:06

Pharma 299
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FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

MedCity News

Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.

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Chest Wearable Provides Key Heart Measurements

Medgadget

Researchers at the University of Texas at Austin have developed a new chest wearable that can obtain both electrocardiogram and seismocardiogram data from the underlying heart. While basic ECG can be monitored via smart watches, no other wearable combines it with seismocardiography, which would conventionally be obtained by listening to the heart using a stethoscope.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. A jury in the Delaware District Court gave a favourable verdict to the Foster City, California-headquartered company, concluding that Gilead did not infringe any of the US government’s patents.

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Telehealth is here to stay, survey shows. How should the industry adapt?

Fierce Pharma

Telehealth is here to stay, survey shows. How should the industry adapt?

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How to Ensure Quality and Reliability for At-Home Lab Tests

MedCity News

Ensuring Quality is the best first step any company, especially startups, can take steps toward preparing for future changes to LDT regulations. Hire and lean on your quality expert to formalize documents to meet requirements, find gaps in best practices, and utilize internal audits to verify standards are being followed.

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FDA publishes paper on AI/ML in drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion. The questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development.

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How Machine Learning Drives Clinical Trial Efficiency

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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Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients. SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli)

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Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

Fierce Pharma

Sandoz taps Evotec in long-term biosimilar development and manufacturing deal fkansteiner Wed, 05/10/2023 - 08:39

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FDA’s Landmark Guidance on Decentralized Clinical Trials (DCTs) Signals a New Era of Patient-Centered Research

MedCity News

With the FDA’s acceptance and encouragement of decentralized trials, we can expect to see a continued shift towards remote trial conduct, virtual sites, and the use of innovative digital technologies.

Patients 122
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Enzyme replacement therapy approved for Fabry disease

European Pharmaceutical Review

A marketing authorisation for PRX-102 (pegunigalsidase alfa) , the first Poly(ethylene glycol) (PEG)ylated enzyme for Fabry disease, has been granted by the European Commission (EC). The approval follows the European Medicines Agency (EMA) human medicines committee’s recommendation of the enzyme replacement therapy (ERT) in February 2023. CHMP recommends first pegylated enzyme for Fabry disease… The PEGylated enzyme replacement therapy Chiesi Global Rare Diseases and Protalix BioTherapeutics, In

Medicine 103
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Ginkgo and Boehringer partner to develop hard-to-treat disease therapies

Pharmaceutical Technology

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

Biopharma 104
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Pfizer, AstraZeneca run it back in IDEA Pharma's annual innovation rankings

Fierce Pharma

Pfizer, AstraZeneca run it back in IDEA Pharma's annual innovation rankings kdunleavy Mon, 05/08/2023 - 10:21

Pharma 279
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Medical Affairs’ Role in Driving Adherence to Evidence-Based Medicine

MedCity News

Medical Affairs plays a critical role when it comes to driving adherence to evidence-based medicine (EBM) – the principle that clinical decisions should be informed by the best available scientific evidence, along with clinical experience and patient preference.

Medicine 122
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Cambridge University receives first synthesized DNA from Evonetix

PharmaTimes

Transfer marks start of vital development stage as company expands its range of synthesized DNA

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Wearable Ultrasound Measures Tissue Stiffness Under Skin

Medgadget

Researchers at the University of California San Diego have developed a wearable ultrasound patch that is intended to provide information on the stiffness of underlying tissues as deep as 4 cm below the surface of the skin. The patch consists of a flexible 16 x 16 ultrasonic array with a silver-epoxy composite backing layer that is designed to absorb excessive vibrations.

Medical 100
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Despite rough quarter, Bayer's duo of Nubeqa and Kerendia continue to excel

Fierce Pharma

Despite rough quarter, Bayer's duo of Nubeqa and Kerendia continue to excel kdunleavy Thu, 05/11/2023 - 10:52

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How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity

MedCity News

Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulting in untold patient harm and billions of dollars globally.

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NHS in Scotland receives Pfizer's migraine treatment

PharmaTimes

Patients living with the debilitating impacts of migraine attacks will be able to access Vydura

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time