Fierce Pharma
AUGUST 7, 2023
Less than four months after Astellas’ $5.9 billion buyout of eye disease specialist Iveric Bio, the deal is already making the Tokyo-based company look visionary. | Less than four months after Astellas’ $5.9 billion buyout of Iveric Bio, the FDA has signed off on the main asset acquired in the deal, the geographic atrophy treatment Izervay.
Pharmaceutical Commerce
AUGUST 7, 2023
Creating a user-centric approach that harnesses both digital tools and behavioral science is key to getting—and maintaining—patients on therapy, and improving clinical, financial, and, ultimately, brand-success outcomes for pharma manufacturers.
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Fierce Pharma
AUGUST 7, 2023
As Pfizer eyes possible cost cuts, its COVID vaccine partner BioNTech is “carefully watching” its spending, the German company’s finance chief Jens Holstein
PharmExec
AUGUST 7, 2023
Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses ways companies can remain accountable for DE&I efforts in pharma in this Pharmaceutical Executive Podcast video.
Fierce Pharma
AUGUST 7, 2023
While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug. | Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage.
MedCity News
AUGUST 7, 2023
Hospitals and outpatient treatment centers in at least three states are struggling to get their systems back online following a ransomware attack waged last week against parent company Prospect Medical Holdings. Some of these facilities have partially or completely halted patient care.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 7, 2023
Clinical trial design will be one of the topics discussed at the upcoming INVEST Digital Health conference in Dallas on October 26. THREAD Clinical Trial Design Director Noah Goodson highlighted some of the milestones the sector has seen in recent years.
Fierce Pharma
AUGUST 7, 2023
By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales. | By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales.
MedCity News
AUGUST 7, 2023
Vistagen Therapeutics’ fast-acting nasal spray drug, fasedienol, hit primary and secondary goals of an abbreviated late-stage study in social anxiety disorder. Vistagen’s stock price rocketed skyward on the results, which support progression to another Phase 3 study.
PharmaVoice
AUGUST 7, 2023
Although research on using oxytocin as a drug has varied, Tonix Pharmaceuticals is banking on the “love hormone” to treat autism, anxiety and more.
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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.
MedCity News
AUGUST 7, 2023
HCA and Tenet reported net incomes for the second quarter, while CHS posted a net loss. All three health systems found themselves in a better financial position in Q2 2023 than they were in Q2 of last year, driven in large part by declining contract labor expenses.
European Pharmaceutical Review
AUGUST 7, 2023
Astellas Pharma has agreed to invest a total of $50 million for the right to license P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumour indications. Under the agreement, the company will acquire approximately 8.8 percent of Poseida Therapeutics. Astellas Pharma will receive a right of exclusive negotiation and first refusal for any potential partnering of P-MUC1C-ALLO1.
MedCity News
AUGUST 7, 2023
About half of adults, or 45%, said they are at least somewhat interested in taking a “safe, effective weight-loss drug,” according to a new survey by KFF. However, just 16% of adults are still interested in taking weight-loss drugs if they’re not covered by insurance.
PharmaVoice
AUGUST 7, 2023
Immunotherapy has revolutionized cancer treatment, yet the drug discovery process to develop new biotherapeutic antibodies remains arduous.
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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
MedCity News
AUGUST 7, 2023
Talkiatry and NOCD are teaming up to improve care for patients with obsessive-compulsive disorder. Talkiatry specializes in medication management, while NOCD specializes in Exposure and Response Prevention therapy.
Pharmaceutical Technology
AUGUST 7, 2023
Health Canada has granted approval for GSK’s Arexvy vaccine to prevent RSV-caused lower respiratory tract disease in older adults.
MedCity News
AUGUST 7, 2023
The major healthcare players have no incentive to bring costs down. Insurers, pharmacy benefit managers, and other healthcare interests profit by charging higher and higher rates. However, one entity has the scale and incentive to meaningfully lower costs: employer health plans.
Pharmaceutical Technology
AUGUST 7, 2023
Iveric Bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY.
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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.
MedCity News
AUGUST 7, 2023
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
European Pharmaceutical Review
AUGUST 7, 2023
For the first-time, researchers have successfully and safely produced the antibiotic cefazolin using continuous-flow manufacturing. While usually produced via batch manufacturing , this latter process is time-consuming, requires specialised equipment results in a large amount of waste. On the other hand: “The method we have developed can cover mass production within compact manufacturing facilities, does not incur huge equipment costs, and can provide a pharmaceutical-grade drug safely and secur
Medgadget
AUGUST 7, 2023
Researchers at the Harvard Wyss Institute have developed an anti-cancer biomaterial treatment that combines adoptive T cell therapy and cancer vaccine technology to treat solid tumors. The researchers have called their technique SIVET, which is short for “synergistic in situ vaccination enhanced T cell”. The approach combines local delivery of cytotoxic T cells with longer lasting cancer vaccine technology that engages with the immune system more broadly for long lasting anticancer action.
Pharmaceutical Technology
AUGUST 7, 2023
Following the approval, Biogen plans for the commercial launch Zurzuvae (zuranolone) in the last quarter of 2023.
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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.
European Pharmaceutical Review
AUGUST 7, 2023
The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. Historically, treatment for PPD has been only available as an IV injection. “The FDA approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” commented Christopher Viehbacher, President and Chief Executive Officer at Biogen.
Pharmaceutical Commerce
AUGUST 7, 2023
How the ‘fight-for-the-dollar’ is coming and likely will impact the bundled pricing of industry stakeholders.
Pharmaceutical Technology
AUGUST 7, 2023
HuidaGene claims its gene therapy candidate was superior to FDA-approved Luxturna in preclinical studies.
PharmExec
AUGUST 7, 2023
Decision comes amid recommendation from agency’s Committee for Medicinal Products for Human Use.
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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
Medgadget
AUGUST 7, 2023
Researchers at the Institute of Science and Technology Austria have developed a brain imaging technique called Live Information Optimized Nanoscopy Enabling Saturated Segmentation (LIONESS). The method lets the researchers create high-resolution 3D images of living brain tissue that reveal its cellular complexity, and even how it changes over time, allowing for monitoring of neural plasticity.
PharmaTimes
AUGUST 7, 2023
Partnership with Icahn School of Medicine will involve developing exoAAV vectors for heart disease patients - News - PharmaTimes
PharmExec
AUGUST 7, 2023
Extension complements pharmaceutical’s total lab solutions portfolio.
PharmaTimes
AUGUST 7, 2023
A combination of zipalertinib and chemotherapy will be evaluated as a treatment for adults - News - PharmaTimes
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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.
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