Fierce Pharma

MARCH 1, 2024

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

Healthcare Provider 275

Healthcare Provider Healthcare Healthcare 275

MedCity News

MARCH 1, 2024

The Pharmacy Guild recently launched and aims to create the first national pharmacy union in the U.S. But it has a difficult road ahead going up against giants like Walgreens and CVS. Still, its organizers expect the union to be successful.

114

114

Fierce Pharma

MARCH 1, 2024

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

Manufacturing 275

Manufacturing 275

MedCity News

MARCH 1, 2024

WebMD acquired the operating assets of Healthwise, a nonprofit provider of health education content and patient engagement tools. The deal follows another acquisition WebMD made in the patient engagement space in 2020. According to Ann Bilyew, WebMD’s senior vice president of health, the company is now “the indisputable market leader in providing patient education to both providers and payers.

Patients 108

Patients Education Marketing 108

Advertisement

Distribution

Fierce Pharma

MARCH 1, 2024

Less than three weeks after a Texas judge tossed a lawsuit b | Less than three weeks after a Texas judge tossed a lawsuit by industry lobbying group PhRMA that challenged the constitutionality of the Inflation Reduction Act, a federal court in Delaware has done the same with a similar action brought by AstraZeneca.

206

206

MedCity News

MARCH 1, 2024

The benefits of healthcare data are undeniable—more informed decisions, better diagnoses, enhanced operational efficiency, improved patient satisfaction—but all that data also creates significant challenges.

Healthcare 106

Healthcare Healthcare Patients 106

MedCity News

MARCH 1, 2024

FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets.

Leads 104

Leads Biopharma Pharma 104

Fierce Pharma

MARCH 1, 2024

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. | The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T c

FDA 176

FDA Marketing 176

MedCity News

MARCH 1, 2024

A surge in cloud adoption by healthcare organizations brings new challenges, particularly in safeguarding data across diverse providers while meeting regulatory frameworks.

Healthcare 99

Healthcare Healthcare 99

Fierce Pharma

MARCH 1, 2024

With a new FDA nod, BeiGene has filled the follicular lymphoma approval gap for BTK inhibitors. | BeiGene has filled the follicular lymphoma gap for BTK inhibitors with an FDA approval for Brukinsa about a year after AbbVie and Johnson & Johnson's Imbruvica stumbled in a phase 3 trial. But tough competition with CAR-T therapies and bispecifics lies ahead.

FDA 163

FDA Competition 163

Advertisement

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

pharmaphorum

MARCH 1, 2024

Pfizer says new oncology division will generate eight new blockbusters by 2030, in first R&D update after its $43bn takeover of Seagen.

107

107

Fierce Pharma

MARCH 1, 2024

North Carolina has proved an attractive destination for biopharma companies large and small in recent years, ginning up investments and site commitments from the likes of Eli Lilly, Fujifilm Diosyn | North Carolina has proved an attractive destination for biopharma companies large and small in recent years, ginning up investments and site commitments from the likes of Eli Lilly, Fujifilm Diosynth, Thermo Fisher and Amgen.

Biopharma 175

Biopharma 175

Pharmaceutical Technology

MARCH 1, 2024

Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.

Pharmaceutical 96

Pharmaceutical 96

pharmaphorum

MARCH 1, 2024

Rare Disease Day saw the debut of a film that aims to raise awareness of cerebral adrenoleukodystrophy (cALD), a devastating and fatal condition with no pharmacological treatments available.

Pharmacology 92

Pharmacology 92

Advertisement

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

Distribution

Impetus Digital

MARCH 1, 2024

To set their Phase II clinical trial of a novel anti-cancer compound up for success, our client sought early multidisciplinary insights on current unmet needs, as well as feedback on their preclinical and early Phase I data and proposed protocol, from three parallel groups comprising oncologists, oncology nurses, and patients. For each group, we executed three virtual touchpoints.

Patients 91

Patients 91

Pharmaceutical Technology

MARCH 1, 2024

During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, attributed to macroeconomic pressures.

104

104

European Pharmaceutical Review

MARCH 1, 2024

Technology trends Current technology trends are influencing consumer behaviour and reshaping the way industry operates. Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement. The post 2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends appeared first on European Pharmaceutical Review.

Manufacturing 85

Manufacturing Pharma Pharmaceutical 85

MedCity News

MARCH 1, 2024

Wellness-oriented consumers are seeking products and practices backed not only by promises but by scientific credibility.

Patients 102

Patients 102

Advertisement

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

European Pharmaceutical Review

MARCH 1, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the first product via its new International Recognition Procedure (IRP). The approval was for a new formulation for XGEVA (denosumab), to prevent serious bone-related complications caused by bone metastasis in adults and to treat giant cell tumour of bone in adults and adolescents.

Medicine 79

Medicine Healthcare Healthcare Marketing 79

pharmaphorum

MARCH 1, 2024

A new formulation of Amgen’s cancer treatment Xgeva is the first to be approved in the UK under a new procedure designed to speed up access to new therapies.

84

84

European Pharmaceutical Review

MARCH 1, 2024

A new £11.5 million investment is set to support the development of innovative solutions to drive advancements in sustainable biomanufacturing in the UK. The UK Research and Innovation ( UKRI ) is backing 21 cross-sector collaborations designed to generate innovation, commercialisation and growth in this area. UKRI highlighted that overall, these investments will “enhance the UK’s global competitiveness by supporting research and innovation that leads to new and disruptive biomanufacturing proce

Manufacturing 76

Manufacturing Pharmaceutical manufacturing Engineering Competition 76

PharmaTimes

MARCH 1, 2024

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities

Patients 100

Patients 100

Advertisement

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

MARCH 1, 2024

German biotech 4SC has filed its oral HDAC inhibitor Kinselby as a maintenance therapy for rare cancer CTCL in the EU

89

89

PharmaTimes

MARCH 1, 2024

TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients

Doctors 95

Doctors Patients 95

European Pharmaceutical Review

MARCH 1, 2024

Articles included in Issue 1 of European Pharmaceutical Review include: FOREWORD Validation of analytical procedures – ICH Q2(R2) David Elder, David P Elder Consultancy REGULATORY INSIGHT The EU pharmaceutical reform: tweaks to marketing authorisation procedures Vladimir Murovec, Osborne Clarke SEPARATION & PURIFICATION IDF Fractionation, purification and downstream processing: the path to commercialisation Rob Abbenhuis, Ardena PAT Process analytics for the new era of continuous RNA manufac

Pharmaceutical 64

Pharmaceutical Consulting Manufacturing Marketing 64

Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. While advancements in percutaneous coronary intervention (PCI) technologies are ongoing, recent research indicates that ISR, the gradual re-narrowing of a previously opened coronary artery, still occurs in up to one in 10 patients post-treatment.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Advertisement

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

European Pharmaceutical Review

MARCH 1, 2024

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries. Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Food and Drug Administration 59

Food and Drug Administration Manufacturing Pharmaceutical products Food 59

Pharmaceutical Commerce

MARCH 1, 2024

A JAMA Network Open study dives into how the utilization of a digital patient portal changed during the COVID-19 pandemic, while also exploring ways that multimorbidity and socioeconomic disparities affected those statistics.

Patients 52

Patients Networking 52

Cesare Ferrari

MARCH 1, 2024

After discussing value proposition in general and with respect to the customer and the product , in this post, I would use the value proposition canvas to analyze the value proposition of a medical product and its product market fit. Inclusively, I’ll evaluate the value proposition of hyaluronic acid injections with a specific customer segment in a defined context.

Medical 52

Medical Side effects Prescription Consulting 52

Pharmaceutical Commerce

MARCH 1, 2024

With its aims to protect healthcare consumers against the dangers of counterfeit, contaminated, stolen or otherwise harmful drugs, the DSCSA represents a significant step forward in securing the pharmaceutical supply chain.

Pharmaceutical 52

Pharmaceutical Safety Healthcare Healthcare 52

Advertisement

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