Mon.Jul 08, 2024

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Lilly's Mounjao triggers more weight loss than Novo Nordisk's Ozempic: study

Fierce Pharma

Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? | Is Eli Lilly’s Mounjaro or Novo Nordisk’s Ozempic more effective in helping patients lose weight? While a head-to-head trial pitting the two treatments remains ongoing, new evidence shows that Lilly’s tirzepatide may be the superior weight loss product.

Patients 303
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How Can Hospitals Best Leverage Multi-Cancer Screening Tests? Providence Researchers Aim to Find Out

MedCity News

Providence recently launched a study to help learn more about how health systems can use multi-cancer detection tests in clinical care. Three years ago, Providence became the first health system to use Grail’s Galleri test, which screens patients for more than 50 kinds of cancer. The post How Can Hospitals Best Leverage Multi-Cancer Screening Tests?

Patients 107
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Merck puts 1,000-plus Zostavax lawsuits to bed after plaintiffs file for dismissal

Fierce Pharma

After a drawn-out litigation process, Merck & Co. seems to have finally washed its hands of more than a thousand lawsuits tied to its shingles vaccine Zostavax. | A U.S. appeals court has tossed a request to resurrect certain lawsuits claiming Merck’s popular shot Zostavax caused patients to develop shingles. The court made its decision after the plaintiffs filed a voluntary dismissal some two years after logging a loss in Pennsylvania.

Patients 262
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A No-Go for HilleVax as Norovirus Vaccine Fails Mid-Stage Test in Infants

MedCity News

HilleVax’s norovirus vaccine failed a Phase 2b study in infants, but it’s not the end of the road for the biotech. A business deal this year brought HilleVax a Phase 1-ready norovirus vaccine candidate designed to offer even broader protection. The post A No-Go for HilleVax as Norovirus Vaccine Fails Mid-Stage Test in Infants appeared first on MedCity News.

Biopharma 106
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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CDMO Lotte breaks ground on $3.3B production plant in Korea, touts growth goals

Fierce Pharma

After announcing plans last year to expand manufacturing in its home country, Korean CDMO newcomer Lotte Biologics has kicked off work on a sprawling facility along Incheon’s waterfront near Seoul. | Late last week, Lotte Biologics broke ground on its flagship facility at the Songdo Bio Campus in Incheon International City, South Korea. The company is pitching the production effort as a key part of its quest to become one of the top 10 CDMOs in the world.

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The Syringe Recall: A Case for Improved Recall Communications

MedCity News

There is an urgent need for a universal electronic platform for recall communications. The post The Syringe Recall: A Case for Improved Recall Communications appeared first on MedCity News.

More Trending

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AI Enhancing Multidisciplinary Care in the Autism and IDD Community

MedCity News

Care coordination is complex, but if done effectively, it can positively impact both the learner and the professionals delivering care. The post AI Enhancing Multidisciplinary Care in the Autism and IDD Community appeared first on MedCity News.

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Roche to reintroduce eye implant med Susvimo 2 years after recall

Fierce Pharma

Roche's launch of eye implant Susvimo was stopped short in 2022 after manufacturing concerns led to a market withdrawal. Now, with the FDA’s blessing to reintroduce the therapy, the | The company is reintroducing the therapy after receiving the FDA's blessing for updates made to the device, ending a two-year voluntary recall.

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Cleanroom microbiology: single-temperature incubation for EM

European Pharmaceutical Review

Single- or mono-temperature incubation is not easy to implement, but it offers efficiency and performance advantages and an opportunity to simplify the process in a pharmaceutical microbiology laboratory. This article shares our motivations, approach and experience of implementing mono-temperature incubation in our laboratories over the past several years.

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With Boehringer ruling, industry extends legal losing streak against Medicare price negotiations

Fierce Pharma

As the process surrounding Medicare's drug price negotiations rolls on this summer—and as the pharmaceutical industry continues to loudly voice its complaints—another lawsuit contesting the legal v | Boehringer Ingelheim joins AstraZeneca, J&J and Bristol Myers Squibb in having a case challenging Medicare price negotiations fail to bear fruit.

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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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Myricx Bio gains $114m in Series A round to develop NMTi-ADCs

Pharmaceutical Technology

Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.

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J&J's tuberculosis med Sirturo lands full US, EU approvals after more than a decade on the market

Fierce Pharma

It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. | The traditional approvals follow initial accelerated approvals granted by the FDA in 2012 and the European Commission in 2014.

Marketing 221
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Report: Covid-19 Policy Changes Made Healthcare More Affordable

MedCity News

Several policy changes, including the Medicaid continuous enrollment provision and enhanced Marketplace tax credits, improved health coverage and access during Covid-19, a new report showed. The post Report: Covid-19 Policy Changes Made Healthcare More Affordable appeared first on MedCity News.

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Lilly scores against Novo Nordisk in weight loss contest

pharmaphorum

An observational study has suggested that Lilly’s tirzepatide is better at achieving weight loss than Novo Nordisk's semaglutide

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lilly bolsters IBD portfolio with $3.2bn Morphic acquisition

Pharmaceutical Technology

Morphic’s lead asset MORF-057 is being investigated in three IBD clinical trials, with data in ulcerative colitis expected next year.

Leads 98
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Myricx raises £90m after pivot to ADCs for cancer

pharmaphorum

Myricx Bio taps into the red-hot interest in companies working on antibody-drug conjugates (ADCs) for cancer, raising £90m in its Series A

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GSK and MVV launch malaria medicine in Brazil and Thailand

Pharmaceutical Technology

GSK and MMV have announced the launch of tafenoquine to prevent the relapse of P. vivax malaria in Brazil and Thailand.

Medicine 102
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Study finds GLP-1 drugs may cut obesity-related cancers

pharmaphorum

GLP-1 agonists like Novo Nordisk's Ozempic reduce the risk of 10 of 13 cancers associated with obesity in an observational study.

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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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Eli Lilly Shows Appetite for Oral Immunology Drugs, Swallowing Morphic in $3.2B Deal

MedCity News

Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. The post Eli Lilly Shows Appetite for Oral Immunology Drugs, Swallowing Morphic in $3.2B Deal appeared first on MedCity News.

Medical 72
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As IARC uprates talc cancer risk, will J&J be affected?

pharmaphorum

IARC has published a new assessment of talc’s potential to cause cancer, concluding that is it ‘probably carcinogenic’ to humans

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Coloplast launches digital leakage notification system Heylo for stoma patients

PharmaTimes

More than 176,000 people in the UK are living with a stoma, according to NHS data

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Could Spain’s Grifols be heading for de-listing?

pharmaphorum

The family that owns Spanish pharma Grifols and private equity firm Brookfield may take the company private in a deal worth around €5.

Pharma 81
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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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Lessons from Lions: EVERSANA INTOUCH Takes on Cannes 

Eversana Intouch

For 70 years, the Cannes Lions International Festival of Creativity showcases the best of the best of the world’s advertising and creative communications. Moreover, it interrogates what good creative is, and what it could be. This year, EVERSANA INTOUCH took a small but intrepid band to Cannes to gather insight. Among them, to our pride, were Susan Perlbachs, Chief Creative Officer at EVERSANA INTOUCH, was a member of the Cannes Lions Health 2024 Pharma Jury, chosen with another 9 peers from aro

Pharma 59
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Lilly swoops on Morphic to claim IBD drug candidate

pharmaphorum

Eli Lilly boosts its inflammatory bowel disease pipeline with a $3.

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The FDA pushes concrete plans to further diversity in clinical trials

PharmaVoice

The long-awaited guidance offers a more detailed road map for pharma.

Pharma 119
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The Nexus between patient and big pharma: Patient-centricity considerations for CDMO and CRO collaborations in novel drug development

PharmaTech

The concept of patient centricity is gaining significant traction in the pharmaceutical industry, reshaping the way drugs are developed and produced. This report, developed in partnership with CPHI, specifically explores how optimizing the pharmaceutical supply chain can help improve patient-centricity, and showcases examples of it already being implemented at large.

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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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FDA Approves Genentech’s Vabysmo to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema Following Retinal Vein Occlusion

PharmExec

The Vabysmo prefilled syringe is designed to simplify administration for retina specialists, improving the treatment experience for both physicians and patients with wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.

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Mission awarded $5.2m to advance potential Parkinson’s treatment

PharmaTimes

The progressive neurodegenerative condition affects around 153,000 people in the UK

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FDA Grants Full Approval to Johnson & Johnson’s Sirturo for Pulmonary Tuberculosis Caused by Mycobacterium Tuberculosis Resistant to Rifampicin and Isoniazid

PharmExec

Results from the Phase III STREAM Stage 2 study show the efficacy and safety of an all-oral bedaquiline-containing regimen for multidrug-resistant pulmonary tuberculosis.

Safety 52
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UK pharma group reprimands Novo Nordisk for undisclosed payments

Pharmaceutical Technology

The Association of the British Pharmaceutical Industry (ABPI) also called out Novartis, Pfizer, and Otsuka for breaching its code.

Pharma 59
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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.