Fierce Pharma

JUNE 24, 2024

In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.

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MedCity News

JUNE 24, 2024

Multiple stakeholders are to blame for prescription drug costs, including pharmaceutical companies and PBMs, according to Merith Basey, executive director of Patients for Affordable Drugs. The post Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In appeared first on MedCity News.

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Prescription Pharmaceutical Patients Pharma 136

Fierce Pharma

JUNE 24, 2024

After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.

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Government 303

MedCity News

JUNE 24, 2024

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. The post FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP appeared first on MedCity News.

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Fierce Pharma

JUNE 24, 2024

Following Novo Nordisk’s recent Wegovy approval to cut heart risks in adults with obesity, Eli Lilly appears to be homing in on the next potential label expansion for its rival GIP/GLP-1 weigh | Late last week, Lilly shared detailed results from its phase 3 SURMOUNT-OSA study, which found that Zepbound at the 10 mg and 15 mg doses aced its primary and secondary endpoints in obese patients with obstructive sleep apnea (OSA).

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MedCity News

JUNE 24, 2024

There is an urgent need for health systems to develop efficient strategies that balance improved patient outcomes with financial health — here are three areas to focus on. The post Unraveling Healthcare Innovation Spend: Where Healthtech Founders Need to Focus appeared first on MedCity News.

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Healthcare Healthcare Patients 110

MedCity News

JUNE 24, 2024

Healthcare organizations must ensure that every solution incorporated into the connected ecosystem is designed and tested to validate that it is secure, compliant, and performs as expected. The post Connected Healthcare: Solving the Challenges with Medical Devices appeared first on MedCity News.

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Healthcare Healthcare Medical 108

Fierce Pharma

JUNE 24, 2024

Despite coming to market second, Bristol Myers Squibb’s Mirati Therapeutics-inherited cancer med Krazati has gained the lead on its Amgen rival Lumakras in a heated KRAS race. | Late Friday, the U.S. FDA granted an accelerated approval for BMS’ KRAS inhibitor Krazati plus Eli Lilly’s Erbitux (cetuximab) to treat certain chemotherapy-experienced adults with KRAS-mutated locally advanced or metastatic colorectal cancer.

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Leads FDA Marketing 216

MedCity News

JUNE 24, 2024

Novant Health called off its planned $320 million acquisition of two CHS-owned hospitals in North Carolina. The decision came after an appellate court granted the FTC an emergency injunction to block the deal — the agency had been challenging the deal for more than a year. The post FTC Involvement Forces Novant Health to Scrap Its $320M Deal with CHS appeared first on MedCity News.

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Fierce Pharma

JUNE 24, 2024

Following last week’s news that generic drugmaker Hikma is acquiring parts of Xellia’s assets in the U.S., the Danish drugmaker has unveiled plans for a fresh round of layoffs. | In connection with the sale of the company’s Bedford plant on the outskirts of Cleveland, Ohio, to Hikma, Xellia said it’s cutting 247 positions in the U.S. Of the affected staffers, 214 work at the Bedford facility, Xellia said in a Worker Adjustment and Retraining Notification alert sent to the state.

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Sales 198

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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.

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Pharmaceutical Technology

JUNE 24, 2024

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

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Fierce Pharma

JUNE 24, 2024

Over the years, ANI Pharmaceuticals has grown itself in part through a series of strategic acquisitions. | Over the years, ANI Pharmaceuticals has grown itself in part through a series of strategic acquisitions. Now, the company has inked a sizable deal to get its hands on ophthalmology specialist Alimera Sciences and its two approved commercial drugs.

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Pharmaceutical 198

pharmaphorum

JUNE 24, 2024

Fenofibrate, a decades-old drug used to lower cholesterol levels, has been shown to reduce the progression of diabetic retinopathy in a large-scale trial.

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Pharmaceutical Commerce

JUNE 24, 2024

A study examines the economical validity of using this therapy as a treatment for unresectable stage III non–small cell lung cancer.

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pharmaphorum

JUNE 24, 2024

Daiichi Sankyo has a second approval in Japan for Ezharmia, its first-in-class dual EZH1 and EZH2 inhibitor, as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL).Ezharmia (valemetostat tosylate) remains the first and only drug in the class to be approved for marketing around the world, having been cleared in Japan in 2022 for relapsed or refractory adult T-cell leukaemia/lymphoma (ATL).

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Marketing 95

Pharmaceutical Technology

JUNE 24, 2024

Big pharma and their packaging partners are collaborating to cut emissions and deliver more sustainable solutions for injectables.

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Pharma 95

pharmaphorum

JUNE 24, 2024

Alnylam shares spike after vutrisiran aces HELIOS-B trial in ATTR-cardiomyopathy, setting up regulatory filings

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European Pharmaceutical Review

JUNE 24, 2024

SGS customers now have easier access to biopharmaceutical insights as the Birsfelden, Switzerland lab adds a stability studies service. The lab now offers reliable, cost-efficient stability testing, including sample storage and related analytical services under controlled conditions, adhering to ICH Q5C guidelines. SGS project managers oversee studies.

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Safety

pharmaphorum

JUNE 24, 2024

Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer

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FDA 100

Integrity Solutions

JUNE 24, 2024

Imagine having a sales team coach who sees the potential in you that you don’t even see in yourself—and then is committed to helping you help live up to that potential. Most leaders agree that the role of sales team coach play a key role in helping salespeople achieve their goals. However, there’s a big gap between this recognition of the importance of coaching and the amount of coaching that’s actually being done.

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Sales Sales Management Management Sales tools 61

pharmaphorum

JUNE 24, 2024

Novo Nordisk boosts manufacturing capacity for GLP-1 drugs again, unveiling a $4.

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Manufacturing 99

Pharmaceutical Commerce

JUNE 24, 2024

The latest news for pharma industry insiders.

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Pharma 105

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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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Pharmaceutical Technology

JUNE 24, 2024

The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.

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FDA 59

PharmaVoice

JUNE 24, 2024

With a career focused on striking deals, Kaan Cartel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.

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Leads 59

PM360

JUNE 24, 2024

In the rapidly evolving global healthcare landscape, the relationship between patients and healthcare professionals (HCPs) remains crucial for effective treatment and care delivery. However, maintaining meaningful interactions between patients and physicians has become increasingly challenging amid the complexities of clinical data management and modern medical practice demands, impacting patient satisfaction, trust, and healthcare outcomes.

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Pharmaceutical Commerce

JUNE 24, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Fran Gregory, PharmD, Vice President of Emerging Therapies, Cardinal Health, discusses ways that changes made to reimbursement models are affecting patient therapies in the biosimilar space.

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Patients Pharma 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

PM360

JUNE 24, 2024

Deerfield Agency discusses patient centricity in rare disease and their perspectives with Tim Pigot, Chief Commercial Officer of Aerovate, and Colleen Brunetti, PAH patient and advocate. Too often, companies delay engaging the patient community until they have early evidence of a drug’s potential benefit. Companies can and should engage patient advocates as active partners in advancing new treatments, providing guidance on everything from trial design to marketing and engagement activities.

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Pharmaceutical Technology

JUNE 24, 2024

Despite a difficult investing environment, major well-capitalised contract manufacturing organisations (CMOs) have been involved in recent acquisitions, as big pharma and private equity alike highly value the manufacturing capabilities and expertise these companies bring to the table.

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Manufacturing Pharma 52

PM360

JUNE 24, 2024

Rare Disease, Uncommon Marketing A healthcare challenger brand has a unique set of circumstances. It may not have a clinical advantage, first-in leverage, a unique mechanism of action, a breakthrough product profile, or the ability to outspend. What it does have is potential that needs to be met. In the case of companies tasked with marketing a rare disease treatment, there are even more specific challenges that go beyond brand-building.

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PharmExec

JUNE 24, 2024

Accelerated approval for Krazati is based on results from the Phase 1/2 KRYSTAL-1 study, which demonstrated a 34% objective response rate in patients with previously treated, locally advanced, or metastatic colorectal cancer.

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FDA Patients 52

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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.

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