World of DTC Marketing
AUGUST 19, 2022
The Inflation Reduction Act’s health insurance subsidies and drug pricing reforms will improve health care affordability for Americans but won’t do a damn thing for our overall healthcare costs, which will keep rising. High drug and health care costs prevent millions of Americans from achieving total health. Nearly 1 in 2 American adults report difficulty affording health care costs.
MedCity News
AUGUST 19, 2022
Contract developer Minnetronix Medical recently developed and commercialized its own product: MindsEye, which it says is the first minimally invasive deep brain access port. The port addresses an unmet need in the neurology market — certain forms of stroke and cancer cause lesions that are deep in the brain, and removing them can be a very invasive and dangerous process.
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Medgadget
AUGUST 19, 2022
Researchers at New York University have created a wearable system that can measure electrodermal activity, a property of the skin that is influenced by mental states, such as stress or excitement. The system is called Multimodal Intelligent Noninvasive brain state Decoder for Wearable AdapTive Closed-loop arcHitectures (MINDWATCH) and it can assess electrodermal activity by measuring skin conductance.
MedCity News
AUGUST 19, 2022
The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. The regulatory decision makes the twice-daily pill the first new oral drug approved to address a novel depression target in more than 60 years.
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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
PharmaTech
AUGUST 19, 2022
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
MedCity News
AUGUST 19, 2022
Hawaii, Maryland and Ohio are the latest to join in extending postpartum Medicaid and Children’s Health Insurance Program coverage for 12 months after pregnancy. In total, 21 states have adopted an extension.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 19, 2022
Advanced technologies, such as AI-guided robotics and automation, offer a potential solution to the provider shortage by freeing healthcare professionals from repetitive and time-consuming tasks and allow clinicians to focus on tasks that require a specialized touch.
European Pharmaceutical Review
AUGUST 19, 2022
Rising demand for therapeutics, especially in developing markets, is expected to expand the global pharmaceutical contract manufacturing market to $130.2 billion by 2026. The market was valued at approximately $100 billion in 2020. According to market research , factors promoting the 4.6 percent compound annual growth rate (CAGR) of the market include the increasing commercialisation of generics and emerging technologies and small biotechs with limited or no production capabilities driving devel
MedCity News
AUGUST 19, 2022
Check out new developments from Carrum Health, Sema4, Trulla, SpendMend, Monod Bio, and Evry Health.
pharmaphorum
AUGUST 19, 2022
US startup Dr B – formed in 2021 to help match patients seeking a COVID-19 vaccine to suppliers with leftover stock – is branching out into antivirals with the help of an $8 million fundraising. The cash injection will be used to launch a telehealth service that promises to provide prescriptions and services to patients regardless of their ability to pay.
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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.
Medgadget
AUGUST 19, 2022
Bright Uro , a medtech company based in California, has created the Glean Urodynamics System, a catheter-free urodynamics testing system. At present, urodynamics testing can help clinicians to diagnose and assess patients with lower urinary tract symptoms, including a frequent urge to urinate and incontinence. The procedure typically involves inserting a catheter into the bladder and another into the vagina or rectum.
PharmaTimes
AUGUST 19, 2022
NICE approval is for first-line treatment of intermediate and advanced renal cell carcinoma
Pharmaceutical Technology
AUGUST 19, 2022
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has provided interim policy recommendations for the usage of French company Valneva’s Covid-19 vaccine, VLA2001. According to the recommendations, two 0.5ml intramuscular doses of the vaccine are intended to be given as part of the initial dosing regimen. The second dose should be given a minimum of 28 days following the first shot. .
PharmaTimes
AUGUST 19, 2022
Senior public health figures take unusual step of warning government about energy costs
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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.
Pharmaceutical Technology
AUGUST 19, 2022
The European Commission (EC) has granted approval for Celltrion Healthcare ’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer. Vegzelma (CT-P16) is a bevacizumab biosimilar referencing Genentech’s Avastin, which is approved in the EU.
Penrod
AUGUST 19, 2022
The choice between Salesforce Sales Cloud and Health Cloud often comes down to compliance. As heightened security becomes increasingly necessary in a healthcare landscape defined by risk mitigation, the compliance advantages of Health Cloud are often enough to make it a no-brainer. However, Health Cloud carries advantages beyond just enhanced security for providers, labs, pharmaceuticals, and medical device companies.
Pharmaceutical Technology
AUGUST 19, 2022
The UK National Institute for Health and Care Excellence (NICE) has r ecommended Vifor Fresenius Medical Care Renal Pharma’s Tavneos (avacopan) plus rituximab or cyclophosphamide to treat adults with two ANCA-associated vasculitis (AAV) forms. The treatment is indicated for severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the two forms of AAV.
pharmaphorum
AUGUST 19, 2022
The European Commission has approved Oncopeptides’ Pepaxti in combination with dexamethasone for multiple myeloma patients with so-called triple class refractory disease – in other words those who don’t respond to all three of the major classes of treatment for the blood cancer. The approval means that Pepaxti (melphalan flufenamide) can now be used as a rescue therapy for adults with multiple myeloma who have previously failed treatment with at least one proteasome inhibitor, one im
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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.
Pharmaceutical Commerce
AUGUST 19, 2022
Optimizing the use of data and improving the patient experience go hand in hand.
pharmaphorum
AUGUST 19, 2022
Reeling from the recent failure of its lead product in a pivotal trial, Nordic Nanovector has formally started a restructuring process and called in investment bank Carnegie to help explore its options. The Norwegian biotech was hit hard in July when the PARADIGME study of Betalutin ( 177 Lu lilotomab satetraxetan) – an anti-CD37 antibody radionuclide conjugate being tested as a third-line therapy for patients with follicular lymphoma – was abandoned after being plagued with recruitment issues.
Pharmacy Times
AUGUST 19, 2022
Douglas Hoey, PharmD, MBA, CEO of National Community Pharmacists Association (NCPA), discusses potential causes and solutions for the current staffing issues facing so many community pharmacies.
pharmaphorum
AUGUST 19, 2022
Australia’s CSL has said its one-monthly treatment for hereditary angioedema has shown it is safe and effective in a phase 3 trial, and will be filed for approval in its current financial year which ends on 30 June next year. The VANGUARD trial of garadacimab, a Factor XIIa inhibitor, compared a subcutaneous injection of garadacimab given every four weeks to placebo on its ability to prevent the swelling attacks that are a key feature of HAE.
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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.
Pharmacy Times
AUGUST 19, 2022
Francesca Ceddia, MD, senior vice president of respiratory vaccines at Moderna, discussed how mRNA vaccines could change the treatment landscape for respiratory illnesses.
pharmaphorum
AUGUST 19, 2022
Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. The German pharma acquired rights to the TRPV1 agonist also known as MTX-071 last year when it acquired Swiss biotech Mestex, and has started dosing patients in one of three planned phase 3 trials in osteoarthritis of the knee.
Pharmacy Times
AUGUST 19, 2022
Treatment with empagliflozin also found to improve cardiac geometry, myocardial mechano-energetic efficiency, and cardiac function.
pharmaphorum
AUGUST 19, 2022
pharmaphorum Editor-in-Chief Jonah Comstock welcomes Amy Abernethy, president of Verily’s Clinical Studies Platforms and Jennifer Goldsack, CEO of the Digital Medicine Society for the first half of a far-reaching discussion about how big data is transforming healthcare. Healthcare innovators have been talking about being data-driven for a long time.
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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
Pharmacy Times
AUGUST 19, 2022
Investigators used the FDA-approved concussions test i-STAT TBI Plasma and the company’s core laboratory Architect instrument.
Pharmaceutical Commerce
AUGUST 19, 2022
CDMO filling capacity now exceeds 50 million units yearly.
Pharmacy Times
AUGUST 19, 2022
Auvelity uses the first new oral mechanism of action for major depressive disorder in more than 60 years.
pharmaphorum
AUGUST 19, 2022
Who remembers that line from the movie Zoolander, “ the files are IN the computer ?!” Twenty years later and we’re now all painfully familiar with our computer’s file structure. But as we continue to digitise clinical trials, has access to new streams of valuable data become easier because “the data is IN the cloud”? Connected sensor technologies and tools, from wearables, smart speakers, and bed mats to ingestible sensing capsules and implantables, are capturing unprecedented flows of data with
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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.
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