pharmaphorum

JUNE 27, 2022

An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes

Sales 113

Sales Patients Leads Medical 113

MedCity News

JUNE 27, 2022

Against the backdrop of the pandemic, the preferences and expectations of healthcare consumers have […].

Networking 141

Networking Management Healthcare Healthcare 141

pharmaphorum

JUNE 27, 2022

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatmen

Side effects 108

Side effects Transportation FDA Recruitment 108

Pharmaceutical Technology

JUNE 27, 2022

Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection

Networking 105

Networking Pharmaceutical Patients Medical 105

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

European Pharmaceutical Review

JUNE 27, 2022

Sickle cell disease – a rare, yet prevalent, genetic disease in Europe. Sickle cell disease (SCD) is a devastating, lifelong blood disorder that occurs when someone inherits sickle cell genes from both parents. 1 It affects haemoglobin, a protein carried by red blood cells that delivers oxygen throughout the body. 2 SCD predominantly affects those whose ancestors are from sub-Saharan Africa but is also common in people of Hispanic, South Asian, Southern European and Middle Eastern ancestry. 3 Wh

Pharmaceutical 103

Pharmaceutical 103

Pharmaceutical Technology

JUNE 27, 2022

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. Breyanzi is given as a defined composition for reducing the variability of the CD8 and CD4 component dose.

Food and Drug Administration 105

Food and Drug Administration FDA Food Safety 105

MedCity News

JUNE 27, 2022

Providers’ digital profiles must be robust in order to best attract and retain patients, according to a new report. Nearly all providers included in the study said that it is important for the hospitals or health systems that employ them to take a more active role in managing their profiles.

Doctors 98

Doctors Management Patients 98

PharmaVoice

JUNE 27, 2022

The CEO of SaNOtize is tapping into outside-the-box innovation to develop a nitric oxide-delivery platform to treat and prevent COVID-19.

111

111

MedCity News

JUNE 27, 2022

A pediatric health system enlisting mixed reality and 3D printing technology illustrates how clinical collaboration and patient education can improve patient outcomes for complex procedures.

Patients 98

Patients Education Physicians Medical 98

pharmaphorum

JUNE 27, 2022

The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million. Ipsen is offering $1.45 per share for Cambridge, Massachusetts-based Epizyme – valuing the US company at around $247 million – and is also promising a further contingent value right (CVR) payment of up to $1 per share if Tazverik (tazemetostat) achieves certain development and sales targets.

Biopharma 94

Biopharma Sales Prescription FDA 94

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

MedCity News

JUNE 27, 2022

Experts believe CMS’ price transparency rule is flawed in its design because the highly complex billing data it is asking hospitals to post is too confusing for consumers to understand. The complicated structure of the healthcare system — from care variance to deductibles to billing codes — means that producing an accurate price estimate is virtually impossible.

Healthcare 98

Healthcare Healthcare 98

European Pharmaceutical Review

JUNE 27, 2022

Europe’s Healthier Together initiative. The European Commission (EC) has launched the Healthier Together: EU Non-communicable diseases (NCDs) initiative to support EU Member States in reducing the burden of NCDs by addressing the leading causes of avoidable premature death in Europe and improving citizens’ health and well-being. The €156 million initiative identifies effective actions and the available legal and financial supporting tools across five main areas: cardiovascular diseases, di

Medicine 98

Medicine Healthcare Healthcare Government 98

MedCity News

JUNE 27, 2022

Startups should co-develop products with healthcare providers and figure out how to plant themselves into hospitals and clinics’ operating models. This will allow them to create effective technology, according to the healthcare executives speaking at a Monday panel on alleviating healthcare inefficiencies through innovation.

Healthcare 98

Healthcare Healthcare Healthcare Provider 98

European Pharmaceutical Review

JUNE 27, 2022

Pursuing new paths in targeted protein degradation drug development. Targeted protein degradation (TPD) therapy has grown rapidly as a field, with transformational potential. TPD is poised to be successful in delivering marketed products, but limitations are now starting to emerge, including tumour resistance, a lack of mechanisms for oral dosing, and the inability to penetrate tissues such as the CNS.

Pharmaceutical 97

Pharmaceutical Marketing 97

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

MedCity News

JUNE 27, 2022

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

FDA 98

FDA Pharmaceutical Patients Biopharma 98

European Pharmaceutical Review

JUNE 27, 2022

With expanding biologics pipelines encompassing an increasingly diverse range of new molecular formats, the therapeutic potential of bi-specific antibodies (bsAbs) continues to receive widespread interest. 1 The majority of bsAbs consist of three or more light chain (LC) and heavy chain (HC) combinations and have the advantage of simultaneously binding two antigens via different epitopes on each antigen-binding fragment (Fab) arm ( Figure 1 ).

Recruitment 94

Recruitment Manufacturing Media Leads 94

MedCity News

JUNE 27, 2022

Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.

FDA 98

FDA Sales Biopharma Pharma 98

European Pharmaceutical Review

JUNE 27, 2022

Alexion , AstraZeneca’s Rare Disease group, will invest €65 million to enhance its production capabilities in Ireland. The investment will help the company scale up its biologics manufacturing capacity and expand R&D efforts over the next 18 months. The money will go towards the installation of new drug substance production equipment and warehousing facilities to support ambient and cold storage at two sites: College Park in Blanchardstown and Monksland Industrial Park in Athlone.

Manufacturing 85

Manufacturing Biopharma Medicine Pharmaceutical 85

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

MedReps

JUNE 27, 2022

The job role of medical sales reps is to communicate with clients and sell them medical equipment and services. Conflicts are bound to happen, and sales reps need to know how to handle them. If you’re a medical sales rep looking for tips on handling customer conflict, then this article is for you. We will give you some tips to help you effectively deal with customer disputes without losing your customers.

Medical sales reps 78

Medical sales reps Medical sales Medical Sales 78

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. . The AMCP backed bill (H.R. 7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Admini

Food and Drug Administration 73

Food and Drug Administration Medical Patients FDA 73

PharmaTimes

JUNE 27, 2022

CHMP returns positive opinion on Rinvoq for the treatment of adults with active non-radiographic axial spondyloarthritis

84

84

Pharmaceutical Technology

JUNE 27, 2022

The proportion of pharmaceutical companies hiring for cybersecurity related positions rose in May 2022 compared with the equivalent month last year, with 46.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39.4% of companies who were hiring for cybersecurity related jobs a year ago and an increase compared to the figure of 43.6% in April 2022.

Pharmaceutical 59

Pharmaceutical Recruitment 59

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

PharmaTimes

JUNE 27, 2022

Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions

91

91

Pharmaceutical Technology

JUNE 27, 2022

Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The company will begin an all-cash tender offer through its subsidiary to buy Epizyme’s all outstanding shares for $1.45 per share in cash along with a contingent value right (CVR) of $1.00 for each share.

Food and Drug Administration 59

Food and Drug Administration FDA Food Patients 59

Legacy MEDSearch

JUNE 27, 2022

Centerline Biomedical, Inc. (Centerline), a private medical technology company, announced the closing of a $33 million Series B equity financing led by Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures. This funding will help propel the company into new surgical applications, accelerate its commercial sales and add to its growing clinical evidence repository.

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

Pharmaceutical Technology

JUNE 27, 2022

Turning Point Therapeutics has entered a strategic research and development alliance with the University of Texas MD Anderson Cancer Center (MD Anderson) to advance the evaluation of two of its investigational small molecules for precision cancer treatments. The focus of this strategic alliance will be on drug candidates, repotrectinib and elzovantinib (TPX-0022).

Patients 59

Patients Leads Medical Pharmaceutical 59

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

The Marketing Advantage

JUNE 27, 2022

June 27, 2022 The payout curve against which a sales force is compensated has tremendous ability to motivate the sales force to drive sales—so much so that we are dedicating a three-part series to biopharma payout curve design. The first part of this series explored the six core payout curve shapes and the second part examined when each of these core shapes should and should not be used.

Biopharma 52

Biopharma Sales Competition Marketing 52

Spotio

JUNE 27, 2022

DALLAS, TX. – SPOTIO today announced that G2 Crowd has recognized SPOTIO as one of the top Field Sales and Route Planning providers based on customer reviews. Customer reviews on G2 Crowd ranked SPOTIO as a leader across multiple categories, including Market Presence, Best ROI, Best Meets Requirements, and Most Implementable. Users ranked SPOTIO as a leader in customer satisfaction and market presence in both the G2 Small and Mid-Market Grid reports for Field Sales Software in Summer 2022.

Sales 52

Sales Marketing Networking Management 52

pharmaphorum

JUNE 27, 2022

NHS patients in England who have been waiting more than two years for surgery will be offered treatment in other parts of the country, in a bid to reduce a massive backlog in procedures caused by COVID-19. The option – described by NHS England as a “final push” to eliminate the number of people waiting two years or more for elective care – will be offered to more than 6,000 of the longest waiters, who in can get travel and accommodation costs covered “where appropriate” T

Government 52

Government Doctors Patients Medical 52

Pharmaceutical Commerce

JUNE 27, 2022

Companies hope to combine their cryobiology expertise with dedicated packaging and supply chain services.

74

74

Advertisement

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients