Fierce Pharma

AUGUST 29, 2023

GLP-1 agonists such as Novo Nordisk’s semaglutide and SGLT2 inhibitors like AstraZeneca’s Farxiga are already butting heads in the treatment of diabetes. | GLP-1 agonists such as Novo Nordisk’s semaglutide and SGLT2 inhibitors like AstraZeneca’s Farxiga are already bumping heads in diabetes treatment. AstraZeneca’s biopharma business president, Ruud Dobber, said he’s not concerned about a potential upcoming clash between the two classes in heart failure.

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Biopharma 221

MedCity News

AUGUST 29, 2023

A study on BeMe Health, a behavioral health platform for teens, found that users engaged with the platform eight times on average over a month. The study was done in collaboration with Stanford University.

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Fierce Pharma

AUGUST 29, 2023

As Moderna’s COVID vaccine patent lawsuits wind their way through courts around the globe, Pfizer and BioNTech contend their rival is trying to monopolize the entire mRNA field. | Pfizer and BioNTech have filed a pair of petitions seeking to invalidate two Moderna patents at the heart of the legal proceedings between the mRNA juggernauts.

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MedCity News

AUGUST 29, 2023

We must advocate for the positive impact that technology can have on healthcare outcomes, while also building solutions to create a more equitable health system. This includes traditional, less tech-reliant methods for those unable to embrace technology.

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Fierce Pharma

AUGUST 29, 2023

The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflat | The drugs that made the cut for the first price negotiations are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel.

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MedCity News

AUGUST 29, 2023

Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.

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Pharmaceutical Technology

AUGUST 29, 2023

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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MedCity News

AUGUST 29, 2023

Don’t bet so big on AI solutions with “someday potential” that you ignore tools that can solve challenges and generate ROI now. Here are five critical AI investments that provide “right now” value for health systems, clinicians and patients.

Patients 101

Patients 101

Copyright Clearance Center

AUGUST 29, 2023

August 29, 20 23 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces that its President and CEO, Tracey Armstrong, was named to the Forbes 2023 “ 50 Over 50 ” list. The third annual Forbes “50 Over 50” list features a collection of powerful founders, innovators, and creators that have a deep sphere of influence and are changing the world.

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Leads 98

MedCity News

AUGUST 29, 2023

The Apellis Pharmaceuticals restructuring will save up to $300 million. It comes as the biotech continues its inquiry into the cause of a rare inflammatory complication reported in a small number of patients who received its geographic atrophy drug, Syfovre.

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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

PharmaVoice

AUGUST 29, 2023

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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MedCity News

AUGUST 29, 2023

HHS released the first 10 drugs selected for the Medicare Drug Price Negotiation Program. These drugs include Eliquis, Jardiance and Xarelto. Under the program, the federal government will be able to negotiate the price for selected drugs for the first time.

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European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated.

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MedCity News

AUGUST 29, 2023

Luna — an at-home physical therapy provider — released a new study on the efficacy of its post-surgery rehabilitation program. The study, which was conducted by the startup, showed that the Luna Pathways program did a good job of reducing patients’ pain, increasing care plan adherence, and decreasing avoidable hospital readmissions and emergency department visits.

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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

Distribution

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration.

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PharmaTech

AUGUST 29, 2023

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

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Biopharma Manufacturing 98

MedCity News

AUGUST 29, 2023

Hospital finances worsened in July as volumes dropped, according to a new report. Following four months of growth, hospitals’ median year-to-date operating margin index fell 1.3%, down from 1.4% in June. Hospital finances still remained in a better place than they were last year, given hospitals’ median operating margins were -0.98% in July 2022.

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PharmaTimes

AUGUST 29, 2023

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme - News - PharmaTimes

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FDA 84

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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

Clarify Health

AUGUST 29, 2023

Taking advantage of technological advances like AI , health plans can streamline manual processes such as prior authorization to reduce operating costs and improve margins. With the power of big data, payers can also offer providers clinically based alternatives to prior authorization. By streamlining the approval process for medical services, health plans can reduce unnecessary expenditures, minimize claims denials, and increase patient and provider satisfaction.

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PharmaTimes

AUGUST 29, 2023

ImmunoGen is expected to receive an upfront payment from Takeda plus additional payment - News - PharmaTimes

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Evolve Your Success

AUGUST 29, 2023

Confidence, clinical expertise, and genuine connections are the key ingredients to thriving in the dynamic world of aesthetic medical sales. Step into this world with our guest, Lauren Brown. From her early days at Stryker to her current role as a thriving aesthetic device representative, Lauren unravels the unique blend of science, art, and business that makes this field both challenging and fulfilling.

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Medical sales Medical Sales Patients 52

Penrod

AUGUST 29, 2023

Thinking of joining the Penrod team (woo!!)? You might have some questions about the process we typically follow and how we generally conduct our interviews. Sit tight, because we chatted with our Sr. Talent Acquisition Specialist, Cassie Bonner, to get you those answers. What does the interview process look like at Penrod? Cassie: First, you’ll have an Initial Screen with someone from the Talent/People Team , which is a general intro interview where we learn more about your experience, your int

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Management 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.

Specialization

Legacy MEDSearch

AUGUST 29, 2023

Marrow Access Technologies announced today that it signed a distribution agreement with Spartan Medical. The distribution agreement will provide patients in the Department of Veterans Affairs (VA) and Department of Defense (DoD) access to the SmartShot® Marrow Access Device, a novel solution for using the body’s own stem cells and healing capabilities to treat orthopedic soft tissue injuries of the knee, hip, shoulder, foot, and ankle.

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PharmaTech

AUGUST 29, 2023

The agreement focuses on the research of a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy, owned by Regeneron, designed to enhance proliferation and potency against solid tumors, according to the press release.

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Pharmaceutical Technology

AUGUST 29, 2023

On 21 August, the US Food and Drug Administration (FDA) announced that it had granted an orphan drug designation (ODD) to Redx’s zelasudil (RXC007), which is an oral, selective rho-associated coiled-coil containing a protein kinase 2 (ROCK2) inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF).

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Food and Drug Administration FDA Food 52

PharmExec

AUGUST 29, 2023

Lawsuit comes amid announcement of the first 10 drugs eligible for negotiated prices in 2026.

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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

Pharmaceutical Technology

AUGUST 29, 2023

Takeda has entered into an exclusive collaboration with ImmunoGen to develop and market ELAHERE (mirvetuximab soravtansine-gynx) in Japan.

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Marketing 59

Pharmacy Times

AUGUST 29, 2023

Nirsevimab (Beyfortus) is the first respiratory syncytial virus (RSV) preventative drug to be approved by the FDA, and can protect infants through their first RSV season for up to 5 months.

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FDA 49

Pharmaceutical Technology

AUGUST 29, 2023

Ipilimumab is under clinical development by Bristol-Myers Squibb and currently in Phase I for Metastatic Transitional (Urothelial) Tract Cancer.

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Pharmacy Times

AUGUST 29, 2023

The supplemental biologics license application for amivantamab-vmjw (Rybrevant) is supported by data from the phase 3 PAPILLON trial, evaluating the efficacy and safety of the drug in combination with chemotherapy for those with non–small cell lung cancer.

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Safety 49

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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