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.
Pharmaceutical Technology
NOVEMBER 25, 2022
Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl
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European Pharmaceutical Review
NOVEMBER 21, 2022
The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). SRD-001, the adenovirus associated virus (AAV)-based gene therapy is delivered to cardiac ventricular muscle cells via an intracoronary infusion system (produced by Sardocor, a clinical-stage gene therapy subsidiary of Medera), to increase the protein expression and functional activity of sarcoplasmic reticulum calcium ATPase
MedCity News
NOVEMBER 22, 2022
Based on some independent research that my company commissioned with more than 200 companies, we came to several conclusions that are highlighted in the article. Broadly, however, it signals the false sense of (cyber)security that many companies are currently harboring.
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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
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.
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
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.
Fierce Pharma
NOVEMBER 23, 2022
J&J's nasal spray Spravato bests former AZ drug Seroquel XR in treatment-resistant depression trial. fkansteiner. Wed, 11/23/2022 - 09:26.
pharmaphorum
NOVEMBER 25, 2022
There are approximately 7,000 different types of rare disease and researchers estimate that there are more than 300 million people worldwide living with such a condition, according to the National Institutes of Health (NIH). However, only 5% of rare diseases are estimated to have at least one approved treatment, known as “orphan” therapies. A rare disease is any disease that affects a small percentage of the population.
European Pharmaceutical Review
NOVEMBER 24, 2022
Patients with refractory systemic lupus erythematosus (SLE) were able to go into remission within three months of one small dose of a personalised anti-CD19 CAR T-cell immunotherapy in a clinical study. The German study showed all five young adult patients with systemic lupus erythematosus went into remission, enabling them to stop taking their lupus medications within three months of just one small dose of the CAR T therapy , as it essentially removed their existing B cells.
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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
NOVEMBER 20, 2022
There are currently 97 global digital health companies that are considered unicorns. But getting caught up with the idea of digital health unicorns isn’t very sustainable, according to Emilly Melton, managing partner at Threshold Ventures. Instead of focusing too much on their valuations, she recommended that startups simply focus on getting the capital they need in order to reach the next stage of inflection.
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.
Pharmaceutical Technology
NOVEMBER 25, 2022
In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022. In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.
pharmaphorum
NOVEMBER 21, 2022
Provention Bio has priced its new type 1 diabetes (T1D) prevention therapy Tzield at $13,850 per vial – equivalent to almost $194,000 for its 14-day course – a higher level than had been predicted by industry observers. The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
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.
Fierce Pharma
NOVEMBER 22, 2022
Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck. fkansteiner. Tue, 11/22/2022 - 10:07.
Pharmaceutical Technology
NOVEMBER 20, 2022
The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.
European Pharmaceutical Review
NOVEMBER 22, 2022
A paper, published in Molecules , has developed validated the use of ultra-performance liquid chromatography with triple quadrupole mass spectrometry, or UHPLC-MS/MS, for identification and detection of the ?-lactams cephapirin and ceftiofur in cleaning solutions of the production reactors. Trace detection of ?-lactam antibiotics in cleaning rinse solutions and manufacturing aids in pharmaceutical facilities is crucial and regulated.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
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 21, 2022
ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win. aliu. Mon, 11/21/2022 - 16:29.
Pharmaceutical Technology
NOVEMBER 22, 2022
Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.
European Pharmaceutical Review
NOVEMBER 22, 2022
Triastek, Inc. a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs. T21 is Triastek’s third FDA IND clearance for a 3D-printed medicine.
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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.
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.
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.
Healthcare Success
NOVEMBER 21, 2022
Just like your brick-and-mortar business has to be ADA compliant, your healthcare website must also be accessible to people with disabilities. The problem? The ADA doesn’t offer clear regulations for a compliant website. The bigger problem? ADA accessibility lawsuits are on the rise. If your website isn’t accessible to people with disabilities, you could risk lawsuits, financial liabilities, and damage to your brand reputation.
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
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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
NOVEMBER 20, 2022
For far too long, dentists have focused on drilling and billing rather than optimizing the patient experience — and that’s driving many of our patients away, with terrible results for their dental health.
Fierce Pharma
NOVEMBER 22, 2022
'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says. kdunleavy. Tue, 11/22/2022 - 11:13.
Pharmaceutical Technology
NOVEMBER 25, 2022
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy a
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.
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In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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