Fierce Pharma

JANUARY 26, 2024

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives.

Patients 320

Patients 320

Pharmaceutical Commerce

JANUARY 26, 2024

Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

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Fierce Pharma

JANUARY 26, 2024

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. | With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP).

Education 267

Education 267

MedCity News

JANUARY 26, 2024

ArriVent BioPharma will apply the IPO cash toward furmonertinib, which the biotech says could offer advantages over Takeda Pharmaceutical and Johnson & Johnson drugs that address the same lung cancer target. It’s the second biotech IPO of this week, following CG Oncology.

Biopharma 113

Biopharma Pharmaceutical Pharma 113

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Fierce Pharma

JANUARY 26, 2024

In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. | In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. Now, a little more than a year later, AbbVie is getting in on the action by starting a major production expansion in the Garden City.

Manufacturing 258

Manufacturing 258

MedCity News

JANUARY 26, 2024

GLP-1s continue to be in high demand, and the healthcare industry is watching closely to see how payers decide to cover the drugs going forward. During a virtual panel, payer executives noted that it’s important to remember that GLP-1s won’t be able to solve the country’s obesity crisis by themselves.

Management 112

Management Healthcare Healthcare 112

MedCity News

JANUARY 26, 2024

The shift towards digital pathology has marked a significant advancement in breast cancer diagnosis. High-resolution digital imaging of slides provides pathologists with an unprecedentedly clear and expansive view of tissue samples for their analysis.

Biopharma 105

Biopharma 105

Fierce Pharma

JANUARY 26, 2024

At Sanofi and Regeneron, it’s all about the kids—at least with respect to their recent advancements of anti-inflammatory powerhouse Dupixent. | The FDA has signed off on Sanofi and Regeneron's Dupixent to treat children between the ages of 1 and 11 who weigh at least 33 pounds with eosinophilic esophagitis. Dupixent becomes the first treatment in the U.S. for children in this age group with the disorder.

FDA 223

FDA 223

Pharmaceutical Commerce

JANUARY 26, 2024

A non-randomized control trial investigates whether older adults with multiple chronic conditions can benefit by receiving more specialized services.

Patients 103

Patients Specialization 103

Fierce Pharma

JANUARY 26, 2024

Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will appeal the guidance.

Medicine 217

Medicine Marketing 217

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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

MedCity News

JANUARY 26, 2024

UnitedHealthcare recently launched UHC Hub, which helps self-funded employers manage multiple health solutions and employees gain access to these solutions.

Management 94

Management 94

Fierce Pharma

JANUARY 26, 2024

Bristol Myers Squibb is offering a detailed look at pivotal data showing that an under-the-skin version of its PD-1 inhibitor Opdivo works as well as the original intravenous formulation in kidney | Bristol Myers Squibb is offering a detailed look at pivotal data showing an under-the-skin version of its PD-1 inhibitor Opdivo works as well as the original intravenous formulation in kidney cancer.

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126

Pharmaceutical Technology

JANUARY 26, 2024

CAR-T cell therapies can provide durable cancer remission, however, a recent FDA investigation into reports of secondary T-cell malignancies has increased scrutiny of their risk profiles.

FDA 87

FDA 87

Fierce Pharma

JANUARY 26, 2024

‘The Top Line’: Closing the $1 trillion women’s health gap aellison Fri, 01/26/2024 - 09:55

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143

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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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Copyright Clearance Center

JANUARY 26, 2024

There's a new PID conference in town - PIDfest will take place at the Czech National Library of Technology in Prague on June 11-13, 2024.

Marketing 98

Marketing 98

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg. “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg” “With this

Medicine 84

Medicine Food and Drug Administration FDA Food 84

pharmaphorum

JANUARY 26, 2024

AbbVie has broken ground on a new $223 million expansion of its biologics manufacturing facility in Singapore, creating around 100 new jobs

Manufacturing 84

Manufacturing 84

European Pharmaceutical Review

JANUARY 26, 2024

A paper, published in Nature Chemical Biology has reported the first ‘free-from ‘tree’ production of a key vaccine ingredient sourced from the soapbark tree. Researchers from the John Innes Centre, a research institute in the UK, have reconstituted the chemical pathway of the potent adjuvant molecule QS-21 in a tobacco plant. Bioengineering vaccine adjuvants The paper explained: “QS-21 is a potent vaccine adjuvant currently sourced by extraction from the Chilean soapbark tree.

Pharmaceutical 82

Pharmaceutical 82

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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.

Safety

pharmaphorum

JANUARY 26, 2024

Eli Lilly is weeks away from launching Mounjaro in the UK, after getting approval from the MHRA for a multi-dose injector version for diabetes and obesity

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77

PharmaTimes

JANUARY 26, 2024

In 2022, over 39,000 people in England died prematurely of cardiovascular conditions

Government 96

Government 96

pharmaphorum

JANUARY 26, 2024

Report on UK biotech sector by Tony Blair and William Hague calls for an NHS trust to be set up to oversee and sell patient data

Patients 82

Patients 82

PharmaTimes

JANUARY 26, 2024

HPV is a common group of viruses which can sometimes lead to cancer

Leads 96

Leads 96

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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.

Specialization

pharmaphorum

JANUARY 26, 2024

ArriVent BioPharma completes the second biotech IPO of 2024, raising $175m that will help advance its late-stage lung cancer drug furmonertinib

Biopharma 73

Biopharma 73

Pharmaceutical Technology

JANUARY 26, 2024

Atossa Therapeutics estimates a Q3 Phase II readout for Z-endoxifen, as it plans a Phase III preventative breast cancer trial.

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64

Pharmaceutical Commerce

JANUARY 26, 2024

As providers and healthcare professionals recognize the potential of long-acting injectables to fight the opioid epidemic, many are actively transitioning from oral options to injectables.

Healthcare 52

Healthcare Healthcare 52

PharmExec

JANUARY 26, 2024

In an interview with PharmExec Associate Editor Don Tracy, Jingsong Wang discusses Nona Biosciences’ recent exclusive license agreement with Pfizer Inc. for the development and commercialization of HBM9033.

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52

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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

Leads

MedTechVets

JANUARY 26, 2024

JAN 26th – We were proud to interview MedTechVet Academy Mentor, Mat Pfeffer. Mat the Director of Image Guided Therapy Devices at Philips. “It’s important to have pride in your job. Obviously, nothing will top the pride of serving in the U.S. Marine Corps for 22 years, so when it came time to retire from the military and pursue my next venture, I knew it would be important to have pride in my job, my company, and my industry.

Networking 52

Networking Medical Specialization Recruitment 52

Pharmaceutical Technology

JANUARY 26, 2024

Type-2 diabetes patients continue to be impacted by GLP-1 RA drug shortages in the UK with an NHS alert issuing guidelines on drug substitutions.

Patients 59

Patients 59

Pharmaceutical Commerce

JANUARY 26, 2024

The Identification of Medicinal Product framework seeks to establish a common language for identifying, documenting, and exchanging information about medicinal products.

Pharmaceutical 52

Pharmaceutical Medicine 52

PharmaVoice

JANUARY 26, 2024

Amylyx Pharmaceuticals’ co-founders and co-CEOs Josh Cohen and Justin Klee explain their approach to dual leadership and why it can be a good fit in life sciences.

Pharma 52

Pharma Pharmaceutical 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.

Management