Fri.Jan 05, 2024

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Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Fierce Pharma

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medical records of patients shows no link between use of the GLP-1 drugs and an increase in suicidal though

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19 Senators Urge HHS to Drop Appeal That Would Jeopardize Americans’ Access to Life-Saving Drugs

MedCity News

A bipartisan group of senators sent a letter to HHS asking it to rethink its appeal of a recent federal district court decision that limits the use of “copay accumulators” — which are programs insurers use to prevent medication copay assistance from counting toward patients’ deductibles or out-of-pocket maximums.

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Beleaguered Theravance logs head-to-head trial loss for Yupelri against Boehringer's Spiriva

Fierce Pharma

When Theravance called it quits on a phase 2 JAK inhibitor program last February, the South San Francisco and Dublin-based biopharma company put the majority of its chips on a head-to-head trial pi | In the phase 4 study, Theravance and Viatris’ Yupelri failed to demonstrate greater lung function improvement in adults with COPD versus Spiriva delivered by a dry powder inhaler, Theravance said Friday.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Kismet Health, the University of California at Berkeley’s life science startups, and the companies presenting at the Consumer Technology Association’s pitch contest at CES.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Fierce Pharma Asia—Deal spree by AstraZeneca, J&J, Roche, Boehringer and more; Big Pharma’s China strategy

Fierce Pharma

The last few days of 2023 and the beginning of 2024 featured a flurry of dealmaking by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies | A flurry of deals were inked by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies. Big Pharma companies are also increasingly entrusting commercialization of some products in China to domestic firms.

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Urgent vs. Emergent: Alleviating Overcrowded Emergency Room Pressures

MedCity News

Crowded EDs will continue to plague the healthcare ecosystem and prevent the efficient delivery of care if the structure and education of care, resources, and availability are kept the same. UC can step in with its well-equipped and trained staff so that EDs can focus on what they do best, care for life-threatening situations.

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Eli Lilly Announces New Telehealth, Home Delivery Option for Popular Weight Loss Drug

Pharmaceutical Commerce

LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.

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Collaboration to develop novel AI-designed oncology therapy

European Pharmaceutical Review

Under a new licensing agreement, Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group, gains the global rights to develop and commercialise a novel, small molecule KAT6A inhibitor. This treatment has potential for hormone sensitive cancers such as breast cancer, and other oncology indications. The therapeutic is designed using the artificial intelligence (AI)-platform from Insilico Medicine, the biotech company that is also part of this collaboration.

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Lawmakers Must Protect California’s Kids and Fund Continuous Coverage Now

MedCity News

In predicting that the Medi-Cal coverage protections during the pandemic would end, advocates successfully pushed for California to adopt a continuous Medi-Cal coverage policy for children ages 0-5 – avoiding annual renewals during this vulnerable time in their childhood development. For this important protection to become a reality as soon as possible, we now need the Governor to fund and greenlight this policy immediately–in his January 2024 Budget proposal.

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AbbVie and Umoja to develop new CAR-T therapies for cancer

Pharmaceutical Technology

AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.

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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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Solera Health Expands Platform for Virtual Specialty Care

MedCity News

Solera Health has added virtual specialty care services to its Halo Platform. The new offering is in partnership with 9amHealth, Vori Health and Oshi Health.

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In the post-pandemic era, three players still dominate the infectious disease market

PharmaVoice

Although three companies dominate the space, emerging infectious disease focus areas and a handful of other key players are augmenting the market.

Marketing 105
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5 Healthcare Trends that Will Shape 2024

MedCity News

As we look into the future, 2024 promises a profound transformation. Here are five areas of focus for the upcoming year.

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Optimizing PPC for Multilocation Providers in Healthcare

Healthcare Success

Managing a PPC strategy for any sized business is complex and challenging. But organizations with dozens or hundreds of locations face even more hurdles: Multilocation providers must consider each location’s unique needs, competitive situation, and business objectives—compounding the complexity of managing an accurate and effective PPC (aka pay-per-click or paid search) strategy.

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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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atai invests $50m in Beckley Psytech

pharmaphorum

Beckley Psytech has announced that is has received substantial strategic investment from atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.

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Eli Lilly Launches Telehealth Platform to Sell Certain Drugs Directly to Consumers

PharmExec

The LillyDirect platform will allow patients who are prescribed the popular weight loss drug Zepbound to obtain the drug via Lilly’s at-home prescription delivery service.

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Owkin and Evotec partner to accelerate therapeutics in oncology and I&I

PharmaTimes

The companies will aim to select targets, discover and develop new therapeutics

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Welcome to Healthcare Unbound, powered by Clarify Health

Clarify Health

Welcome to our new podcast, Healthcare Unbound , where healthcare leaders and changemakers discuss ways to advance healthcare outcomes, costs, and affordability. Healthcare Unbound offers listeners a front-row seat to some of the brightest minds working to find solutions to the immense challenges we are facing in every corner of the industry. The podcast is the namesake of the Healthcare Unbound Summit we held in May 2022, where a select group of 150 industry thought leaders, innovators, and

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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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Immune cell helps predict skin cancer patients’ responses to immunotherapies

PharmaTimes

Vd1-gd T cells were effective in predicting positive responses to ICI therapy

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Merck Highlights Robust Oncology, Hematology Pipeline With Four Agents in Phase III Trials

Pharmaceutical Commerce

Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.

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Novo Nordisk begins research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases

PM360

Novo Nordisk, Omega Therapeutics, Inc. and Cellarity Inc. today announced that Novo Nordisk has entered into separate research collaborations with each company. The Omega collaboration will leverage its proprietary platform technology to develop an epigenomic controller designed to enhance metabolic activity as a part of a potential new treatment approach for obesity management.

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Setting the Stage for Specialty Drugs in 2024: Q&A with Tina Fresta, Strategic Solutions Senior Manager at epocrates

PharmExec

Tina Fresta, BA, MPH is the Strategic Solutions Senior Manager at epocrates, keeps a close eye on the pharmaceutical and bio science industry shifts, leveraging those insights to inform both our partners and our company of the most strategic approach to reach business goals.

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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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Intellia propels into 2024 with CRISPR pipeline updates

Pharmaceutical Technology

Intellia Therapeutics announced its clinical goals for the next few years, pushing development for its late-stage ATTR asset.

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Novartis Opens New Radioligand Therapy Manufacturing Facility in Indianapolis

Pharmaceutical Commerce

In the midst of being approved for commercial manufacturing of Pluvict, the 70,000 square-foot site was built specifically to accommodate RLT production.

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Signal: UK online pharmacies selling prescription drugs without proper checks

Pharmaceutical Technology

A BBC team was able to buy over 1600 prescription pills by supplying fake data, raising concerns over limited oversight.

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Zelix Pharmaceuticals Files BLA for PET Imaging Agent for Renal Cell Carcinoma

PharmExec

Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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DoD Grants Additional Funds to MediWound for Advancement of Non-Surgical Treatment for Field Care Burns

PharmaTech

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

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Pharmaceutical Technology Excellence Awards 2023: KAI Conversations

Pharmaceutical Technology

KAI, a technology company based in the UK, is a Category Award Winner for Innovation in the 2023 Pharmaceutical Technology Excellence Awards

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Pivotal Phase III Trials to Evaluate Four Promising Agents in Merck's Oncology, Hematology Pipeline

PharmExec

Merck is actively enrolling patients across Phase III trials for four novel candidates for hematologic malignancies and solid tumors.

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Avistone raises $140m to support drug research and development

Pharmaceutical Technology

Avistone has closed its Series B financing round, raising 1bn yuan ($140m), to support clinical research and development of its drug pipeline.

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Accelerating Clinical Supply Through Integrated Drug Development

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.