Fierce Pharma
NOVEMBER 23, 2022
Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line. zbecker. Wed, 11/23/2022 - 10:10.
European Pharmaceutical Review
NOVEMBER 23, 2022
The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes. Standard treatment for the condition involves replacing the missing or deficient clotting factor to improve the body’s ability to stop bleeding and promot
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
NOVEMBER 23, 2022
Senator aims to cut biosimilar 'red tape' with proposal to eliminate interchangeable status. kdunleavy. Wed, 11/23/2022 - 07:18.
MedCity News
NOVEMBER 23, 2022
Implementing and pursuing innovation in digital health and healthcare IT should be a priority for all U.S. healthcare providers and payers — especially as the lessons and response to the Covid-19 pandemic become permanently part of our everyday lives.
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
Fierce Pharma
NOVEMBER 23, 2022
On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane. kdunleavy. Wed, 11/23/2022 - 09:35.
pharmaphorum
NOVEMBER 23, 2022
The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 23, 2022
November is National Family Caregivers Month in the US, an opportunity to honor those who have taken on this critical role of caring for loved ones, while raising awareness of the challenges they face daily and what needs to be done to drive tangible changes.
Fierce Pharma
NOVEMBER 23, 2022
Teva, AbbVie's Allergan lock in $6.6B deal to settle thousands of US opioid lawsuits. fkansteiner. Wed, 11/23/2022 - 08:05.
MedCity News
NOVEMBER 23, 2022
CSL Behring’s hemophilia B gene therapy, Hemgenix, carries a $3.5 million list price. But the company contends that by reducing economic burdens associated with bleeding and prophylactic infusions, the one-time treatment will save money over time.
pharmaphorum
NOVEMBER 23, 2022
Each person living with a rare disease has a unique experience of their condition, but all will have faced similar challenges. They have suffered from an overwhelming diagnosis experience that has left them feeling misunderstood, isolated, and desperate for someone to help them connect symptoms and make sense of the sheer volume of information. Many will also face barriers to care, where access to specialists is limited and often geographically out of reach.
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.
MedCity News
NOVEMBER 23, 2022
Practices don’t need to lose out on uncollected payments from insurers. Here are steps you can take to better manage coding, tracking, communications and rise above byzantine insurance practices.
Pharmatutor
NOVEMBER 23, 2022
Klotho : A hope for the acute kidney injury-diabetes comorbidity. admin. Thu, 11/24/2022 - 10:12. About Authors. Ajinath Kale, Anil Bhanudas Gaikwad*. Laboratory of Molecular Pharmacology, Department of Pharmacy, Birla Institute of Technology and Science Pilani, Pilani Campus, Rajasthan, India. *anil.gaikwad@pilani.bits-pilani.ac.in.
MedCity News
NOVEMBER 23, 2022
This represents a 17% increase in total ACA plan selections — both through HealthCare.gov and state-based Marketplaces — compared with last year, CMS said. Enrollment through the federal HealthCare.gov has especially seen a rise of 40% from the same period last year.
Legacy MEDSearch
NOVEMBER 23, 2022
The holiday season always brings a time of family, friends, good food, and also reflection on the year. This year as we are in the season of giving thanks, we asked our team what everyone was thankful for this holiday season. Here is what they had to say! “I’m thankful for my family; my wife and our two kids.” – Sean Wilcox, Practice Leader. “This year I am so thankful for my family, my work family, and my wonderful fiancé.” – Melissa King, Digital Marke
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.
MedCity News
NOVEMBER 23, 2022
Third Culture Capital (3CC) is a venture capital firm founded with the mission to foster more equity and diversity in health technology innovation. 3CC Founder and Managing Partner said the firm is intentional about connecting to the “unique lived experiences” of the founders it invests in, as this approach ensures that it is not just checking its diversity boxes.
European Pharmaceutical Review
NOVEMBER 23, 2022
The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU). The QIG, set up in September 2022, is composed of eight members with backgrounds in chemical, biological quality assessment and Good Manufacturing Practice (GMP) inspections, who report
MedCity News
NOVEMBER 23, 2022
Among the takeaways from HLTH 2022 were the impact of consolidation on clinicians, behavioral health tools to help consumers manage stress and anxiety more productively, and how health tech and medtech companies are supporting remote patient monitoring and testing.
pharmaphorum
NOVEMBER 23, 2022
Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself. Speaking with Kornelia Lencz, senior manager at EY Consulting and a business solutions lead for the EY Smart Reviewer Platform – after a spur-of-the-moment, yet highly interesti
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.
European Pharmaceutical Review
NOVEMBER 23, 2022
The first clinical trial to study glenzocimab , a new drug for heart attacks, which could help reduce heart damage and improve patients’ long-term outcomes, promises a new class of drugs for the condition if successful. The study is a partnership between the University of Birmingham and Acticor Biotech. It will recruit over 200 patients to test the tolerance and the efficacy of 1000mg of glenzocimab versus placebo, to reduce heart damage following an ST segment elevation myocardial infarct
PharmaTimes
NOVEMBER 23, 2022
Research showed that prescribing based solely on levels of proteins present is unlikely to be suitable
Penrod
NOVEMBER 23, 2022
The post Customer Data Platforms: A Healthcare Perspective appeared first on Penrod.
PharmaTimes
NOVEMBER 23, 2022
Ganaplacide/lumefantrinein new study as world faces emerging resistance to malaria treatments
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.
pharmaphorum
NOVEMBER 23, 2022
uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy for adults with the bleeding disorder in the US. The adeno-associated virus (AAV) vector-based therapy is given as a one-shot intravenous infusion, delivering a gene for Factor IX, a clotting factor that is deficient in haemophilia B.
Pharmaceutical Technology
NOVEMBER 23, 2022
The European Commission (EC) has granted approval for AbbVie ’s Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) to treat moderately to severely active Crohn’s disease in adult patients. Skyrizi is indicated for usage in such patients with insufficient response, lost response or were not tolerant to standard or biologic therapy.
pharmaphorum
NOVEMBER 23, 2022
In this webinar, sponsored by IQVIA, the panel will discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing funding via this route, and how this will influence uptake of medicines recommended via a NICE technology appraisal.
Contrarian Sales Techniques
NOVEMBER 23, 2022
This course will teach you how to succeed in medical device sales , and it will help you understand the changes that have occurred in the industry. You'll learn the ins and outs of sales, and how to maintain and improve your advantage over the competition. Having the necessary knowledge and skills to make effective calls will allow you to get ahead of the competition and maximize your time.
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
Pharmaceutical Technology
NOVEMBER 23, 2022
Innovations in biotechnology are advancing the biopharmaceutical market, enabling the treatment of complex diseases with next-generation therapeutics synthesised or extracted from a biological source. Lifted by increased interest after the onset of the Covid-19 pandemic, the sector is expected to balloon to US$853 billion by 2030. One of the primary focus areas includes the continued commercialisation of cutting-edge cell and gene therapies, which involve the modification of cells from patients
Contrarian Sales Techniques
NOVEMBER 23, 2022
As hospitals begin to shift from fee-for-service reimbursement to value-based payment methods, they are developing new business models that are designed to improve their efficiency and provide more value to their patients. Some of these include establishing new relationships with physicians, insurance companies, and specialty hospitals. Image source: Amazon.com Due to the emergence of a healthcare continuum, sales professionals are now faced with the challenge of selling their products and servi
PharmaVoice
NOVEMBER 23, 2022
Empowered by her own cancer journey, Nicole Lambert is using her platform as chief operating officer of the genetic testing powerhouse to change the trajectory of care for millions of women.
pharmaphorum
NOVEMBER 23, 2022
6th December | 1pm | Royal Society of Medicine. [link]. The PM Society is excited to announce that their Learning & Development Interest Group will be hosting their inaugural seminar on the 6 th December 2022 in London. The Learning & Development Interest Group spent the summer of 2022 interviewing an array of pharmaceutical marketeers, at all levels.
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.
Expert insights. Personalized for you.
306 
Let's personalize your content