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.

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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

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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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

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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

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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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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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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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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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Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

Fierce Pharma

Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion zbecker Tue, 05/09/2023 - 10:51

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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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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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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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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

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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

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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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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.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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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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As COVID vaccine sales plummet, BioNTech looks for new growth opportunities

Fierce Pharma

As COVID vaccine sales plummet, BioNTech looks for new growth opportunities zbecker Mon, 05/08/2023 - 11:02

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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 120
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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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Roles and Responsibilities of Specialized Clinical Supply Experts

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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Researchers develop CRISPR-based drug candidate for microbiome targeting

Pharmaceutical Technology

The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. Blood cancer patients with E coli infection are at risk of bacteria infecting the bloodstream. An E coli infection can be fatal in these cases, with a 15-20% mortality rate.

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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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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.

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The Ultimate Guide to Healthcare SEO: 3 Techniques Your Website's Organic Marketing Needs

Healthcare Success

A successful health system, hospital, practice, or healthcare organization website facilitates patient communication and helps you win more of the patients you want. But this doesn’t mean much if patients can’t find your website. To get on page #1 for an organic search, you need a strong healthcare marketing SEO company, a solid website, an even stronger medical SEO strategy, and a tactical SEO team.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Takeda reports 12.8% rise in FY2022 revenue

Pharmaceutical Technology

Takeda has reported a 12.8% increase in its reported revenue to $29.96bn (Y4,027bn) during the fiscal year 2022 (FY2022) compared to that reported in FY2021. At a constant exchange rate (CER), the company’s core revenue grew by 3.5% compared to the previous year. In the FY2022 ending 31 March 2023, the company also reported a 6.4% rise in its operating profit to $3.65bn (Y490.5bn) compared to 2021.

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Novartis targets underserved fields—and CAR-T—for next phase of immunology growth: exec

Fierce Pharma

Novartis targets underserved fields—and CAR-T—for next phase of immunology growth: exec aliu Wed, 05/10/2023 - 12:08

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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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Immunotherapy Implant to Treat Pancreatic Cancer

Medgadget

Researchers at Houston Methodist have developed an implant that can provide localized and sustained release of immunotherapies to treat pancreatic cancer. Their device is tiny, at approximately the size of a grain of rice, and they have termed it a “nanofluidic drug-eluting seed” Pancreatic cancer is particularly difficult to treat, and current therapies have problems penetrating the tumor while resulting in significant side-effects elsewhere in the body.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.