Fierce Pharma
JULY 24, 2023
SK Chemicals of Korea has signed a deal with AstraZeneca to manufacture diabetes drug Sidapvia through the rest of the deca | SK Chemicals of Korea has signed a deal with AstraZeneca to manufacture type 2 diabetes drug Sidapvia through the rest of the decade, according to a regulatory filing. Sidapvia was approved in Korea last month.
PharmaVoice
JULY 24, 2023
Amid a wave of neuro R&D, scientists are taking an Alzheimer’s-like approach to developing the first disease-modifying treatments for Parkinson’s.
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Fierce Pharma
JULY 24, 2023
After Teva’s Alvotech-partnered Humira biosimilar suffered its second FDA rejection, the generics giant is stepping up its role in their long-term collaboration with increased manufacturing involve | After Teva and Alvotech's proposed Humira biosimilar suffered a second FDA rejection because of issues at Alvotech's manufacturing plant, Teva is pledging increased involvement at the plant.
Copyright Clearance Center
JULY 24, 2023
Mark Gottlieb with Trident Media Group explores what authors and publishers should know about TikTok’s move into publishing, and how they may want to respond.
Fierce Pharma
JULY 24, 2023
Pfizer and the U.S. FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week. | Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage.
MedCity News
JULY 24, 2023
Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 24, 2023
Social media should play a bigger part in public health crisis planning, according to a recent analysis. The analysis explored the crucial role that Twitter and other social media platforms played when the app for Abbott’s FreeStyle Libre system crashed earlier this month in the U.K.
Fierce Pharma
JULY 24, 2023
With stalwart cancer drug Cabometyx driving its commercial performance, Exelixis has put plenty of effort behind defending the drug's intellectual property. | Exelixis' star franchise generated $1.4 billion last year, demonstrating why the cancer specialist is eager to defend its intellectual property.
MedCity News
JULY 24, 2023
Patients are driving the push away from needles, and there are a number of novel approaches attempting to solve the difficult task of transforming biologics into orally administered treatments.
Fierce Pharma
JULY 24, 2023
With Johnson & Johnson’s consumer health spinoff in the rearview, J&J is taking its hands off the Kenvue steering wheel to focus on its own business—and offering investors an incentive to t | Leveraging a stock exchange offer—also known as a split-off—J&J aims to reduce its stake in Kenvue by roughly 80%, the company said Monday. Under the exchange offer, which is expected to be tax-free, J&J shareholders may exchange all, some or none of their common stock for Kenvue shares, J&a
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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.
Pharmaceutical Technology
JULY 24, 2023
Verrica has received approval from the US FDA for its YCANTH to treat molluscum in adult and paediatric patients aged two years and above.
MedCity News
JULY 24, 2023
In 2020, 46.9% of all novel drugs approved by the FDA were for rare diseases, as compared to 23.5% in 2012. Investment is expected to continue trending upward, with estimates suggesting that global spending on rare disease therapies will reach $260 billion by the end of 2025.
European Pharmaceutical Review
JULY 24, 2023
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on approving ORSERDU ® (elacestrant) for oestrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation in patients with disease progression, following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
Medgadget
JULY 24, 2023
Researchers at the National University of Singapore have created a wound sensor patch that measures various wound biomarkers that can indicate would healing. Chronic wounds are an ongoing problem for many patients, and developing new ways to monitor and treat these painful lesions would be very useful. This battery-free wound patch contains five colorimetric sensors that change color in response to various wound biomarkers.
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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
Pharmaceutical Technology
JULY 24, 2023
Shares in the company dropped by 29% despite assurances the failure would not harm its 2023 financial outlook.
European Pharmaceutical Review
JULY 24, 2023
Proficiency testing programmes aim to increase the product analysis and knowledge to contribute to overall improvement in drug product quality. A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories. Quality assurance for personalised preparations According to the authors, the personalised preparation quality assurance program (PACMI) was created in 2010 at the Facul
PharmExec
JULY 24, 2023
Collaboration aims to help pharmaceuticals drive efficiencies and business value.
PharmaTimes
JULY 24, 2023
The treatment is a monotherapy for treating adult patients with refractory or relapsed multiple myeloma - News - PharmaTimes
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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
JULY 24, 2023
Solution includes assistance with submitting regulatory submissions.
PharmaTimes
JULY 24, 2023
The drug is an injectable or tablet specifically developed for HIV prevention among certain individuals - News - PharmaTimes
Pharmaceutical Technology
JULY 24, 2023
In the Middle East and Africa pharmaceutical industry, there were 4 private equity deals announced in Q2 2023, worth a total value of $49.6m, according to GlobalData's Deals Database.
MedCity News
JULY 24, 2023
Transformations in the Life Sciences is the focus of the second season of the MedCity Pivot Podcast. My personal journey as a caregiver of a cancer patient made me choose Dr. Sumanta Pal, co-director of the City of Hope’s Liver Cancer program as a guest after he co-authored an interesting study on immunotherapy that was published in the Lancet.
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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
JULY 24, 2023
In the Middle East and Africa pharmaceutical industry, there were 4 private equity deals announced in Q2 2023, worth a total value of $49.6m, according to GlobalData's Deals Database.
Clarify Health
JULY 24, 2023
Clarify Advance is a no-admin, at-risk physician incentive program proven to deliver high physician engagement and reliable medical cost reduction, saving up to $6 for every $1 of incentive paid out. Watch our latest video to learn more. Can’t watch right now? Read the video transcript below. Video Transcript: Healthcare payers and providers always want members to receive the highest-value, lowest-cost care.
Curzon Consulting
JULY 24, 2023
Managing Consultant Contact me +44 (0)7931 466792 Parbej is a dedicated Managing Consultant and a trusted partner to senior executives with over 12 years of experience in strategy and large-scale business transformation and change initiatives. With over 12 years of experience primarily in the Financial Services and Banking industry, his expertise covers risk and regulatory programmes, business and operations management, complex programme and project management, post-acquisition / merger integrat
LEVO Health
JULY 24, 2023
In the dynamic world of healthcare marketing, video content has emerged as a potent tool to engage patients and guide them through their healthcare journey. However, it often takes a series of videos, each tailored to a specific stage of the patient journey, to effectively convert potential patients into loyal ones. This comprehensive guide will explore how videos can be strategically used at each stage – awareness, consideration, and decision – to enhance patient commitment to your practice.
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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
Legacy MEDSearch
JULY 24, 2023
Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, today announced that the first participants have been treated in the Open Label Optimization (OLO) Clinical Trial evaluating the effectiveness of the Magnus Neuromodulation System with SAINT Technology for the treatment of Major Depressive Disorder (MDD).
Pharmaceutical Technology
JULY 24, 2023
Artificial intelligence (AI) has the potential to expedite the discovery of new drugs. Using AI-powered platforms, biopharma companies can create research processes that are time and cost-efficient.
Clarivate
JULY 24, 2023
Biopharma and medtech brands made up a dozen of the Clarivate Top 100 New Brands for 2023, as the life science industries continued to show a muscular approach to protecting their intellectual property. The findings put the life science industries on favorable terms with consumer-facing giants like Apple (which counted five brands among the top 100), Huawei (5) and Hugo Boss (4) – all the more remarkable as pharma and medtech brands are generally not sold direct-to-consumer.
Pharmaceutical Technology
JULY 24, 2023
RedHill Biopharma has received funds worth $1.7m from the US government to advance the development of opaganib as a medical countermeasure.
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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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