MedCity News
OCTOBER 26, 2022
Consumer-led healthcare will change patient care pathways, driving the industry to grow and collaborate in new ways, both with patients around their own health and with partners and innovators.
PharmaVoice
OCTOBER 26, 2022
The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.
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MedCity News
OCTOBER 26, 2022
Realizing the value of cloud, life sciences companies and leading pharma organizations across the world’s R&D teams are increasing operations to collaborate and drive clinical trials.
pharmaphorum
OCTOBER 26, 2022
Drugmakers Pfizer and Flynn Pharma have formally launched an appeal against a £70 million ($84 million) fine levied by the UK Competition and Markets Authority (CMA) for overcharging the NHS for a widely-used epilepsy drug. The two drugmakers were fined in July, after the CMA upheld a preliminary judgment that Pfizer and Flynn had abused a dominant position in phenytoin sodium capsules, causing NHS spending on the drug to swell from around £2 million a year in 2012 to £50 million the following y
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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
MedCity News
OCTOBER 26, 2022
The top strategies to support mental health issues are offering coverage for telebehavioral health services, providing onsite or virtual employee assistance programs and providing access to digital behavioral health support, a survey of 455 employers found.
pharmaphorum
OCTOBER 26, 2022
Psoriasis is a tricky disease to manage, as drawbacks and side effects loom with each and every type of treatment. Anyone who watches television has heard the list of potential adverse reactions, considering that commercials for psoriasis treatments are seemingly only outnumbered by goofy ads for auto insurance. Topicals — creams, ointments, foams, and lotions applied directly to the affected areas of the skin — don’t get nearly as much TV time as their systemic biologic counterparts, the
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 26, 2022
Boehringer Ingelheim has moved one of its top pipeline prospects – oral phosphodiesterase 4B (PDE4B) inhibitor BI 1015550 – into late-stage clinical testing for idiopathic pulmonary fibrosis and other interstitial lung diseases (ILDs). The drug was highlighted at Boehringer’s R&D update earlier this year as one of the most promising candidates among 15 new medicines it plans to bring to market by 2025, fuelled by a €25 billion R&D spend.
MedCity News
OCTOBER 26, 2022
A recent study found that AI is equal to humans in identifying red-flag language in text messaging. While some clinicians may be worried about being replaced by AI, experts said the technology is only a tool to support their work.
Copyright Clearance Center
OCTOBER 26, 2022
October 26, 20 22 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has earned several 2022 Top Workplaces Culture Excellence Awards for Employee Appreciation, Employee Well-Being, Professional Development, and being Women-Led. Earlier this year, CCC won national recognition for Compensation & Benefits, Leadership, and Work-Life Flexibility.
MedCity News
OCTOBER 26, 2022
FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA. Though this off-the-shelf drug offers patients a more convenient dosing option, it comes with similar complication risks as other biologics approved for this type of blood cancer.
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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.
PharmaVoice
OCTOBER 26, 2022
The Stanford researcher and biotech entrepreneur discusses how click and bioorthogonal chemistry could revolutionize drug development.
MedCity News
OCTOBER 26, 2022
The industry faces challenges from inflation to labor shortages, according to an annual report from EY. However, there are grounds for optimism and areas to focus on, such as patching up supply chains.
European Pharmaceutical Review
OCTOBER 26, 2022
Some 70-80% of antibody drug conjugate (ADC) developers outsource their operations to contract development and manufacturing organisations (CDMOs) to yield cost savings opportunities, according to a recent market report. Manufacturing agreements emerged as the most popular type of partnership model for ADC developers, adopted by 18 percent of stakeholders, followed by product development agreements (16 percent) and research agreements (15 percent), the market research found. .
MedCity News
OCTOBER 26, 2022
Patient privacy is a winner of the transition to GA4. Making the switch to the new analytics platform will allow your organization to more easily adhere to HIPAA regulations, working with other patient privacy standards to keep patient data safe and secure.
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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.
European Pharmaceutical Review
OCTOBER 26, 2022
Gallogly College of Engineering at The University of Oklahoma (OU) has announced it will open the OU Bioprocessing Core Facility, a shared research centre for biopharmaceutical manufacturing and bioprocess engineering in 2023. Organisations who will benefit from the shared site include academia, clinical research organisations and start-ups. A total of $7 million will support those involved to equip the facility with state-of-the-art technology.
pharmaphorum
OCTOBER 26, 2022
When people think about pharma, they often think about “big” pharma: large, faceless corporations. But Giacomo Chiesi, head of Chiesi Global Rare Diseases, thinks of his 6,000-person company as a family business. And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community.
European Pharmaceutical Review
OCTOBER 26, 2022
Included in this Guide to: The changing face of outsourcing. With pharma/biopharma companies looking to select CDMO partners earlier than before, and in a competitive market, what approaches can be adopted? Here, EPR explores some recent trends and evolving strategies. Make confident operational decisions by understanding your microflora. Are you leveraging all the information from your QC data?
MedCity News
OCTOBER 26, 2022
Kaiser Permanente is a couple months into a first-of-its kind community program focused on helping Americans build their credit. Having no credit or bad credit is a major barrier to financial mobility, which is often a necessity to living a healthy life.
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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.
European Pharmaceutical Review
OCTOBER 26, 2022
Gedeon Richter UK Ltd has announced that the UK National Institute for Health and Care Excellence (NICE) has recommended the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for adults of reproductive age with moderate-to-severe symptoms of uterine fibroids on the National Health Service (NHS) in England and Wales. Ryeqo, the once-a-day relugolix combination therapy comprises of 40mg of relugolix, 1mg estradiol and 0.5mg norethisterone acetate.
PharmaTimes
OCTOBER 26, 2022
The International AIDS Vaccine Initiative is a global nonprofit scientific research organisation
Pharmaceutical Technology
OCTOBER 26, 2022
Over recent years, many pharmaceutical companies have taken up environment, social and governance (ESG) targets in order to prioritize sustainability whilst boosting their external public relations. On October 6, in a GlobalData webinar, experts tried to answer the question ‘ Is Pharma at an ESG turning point?’ , revealing a multitude of diverse strategies for pharmaceutical companies to remain conscious of their global impacts.
pharmaphorum
OCTOBER 26, 2022
German specialty drugmaker Neuraxpharm has licensed commercial rights in Europe to a wearable device developed by Spanish start-up mjn-neuro that is designed to warn a person with epilepsy about an impending seizure. The device – called mjn-SERAS – takes the form of a Bluetooth-enabled earpiece with a custom designed, 3D-printed brain activity sensor that monitors for electrical signal patterns in the brain which may indicate a seizure is on the way, by using an artificial intelligence algorithm
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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.
PharmaTimes
OCTOBER 26, 2022
The annual awards recognise the efforts of NHS teams and individuals
Pharmaceutical Technology
OCTOBER 26, 2022
Bristol Myers Squibb (BMS) has reported a 3% decline in total revenues to $11.2bn in the third quarter (Q2) of 2022 as against $11.6bn in the year-ago quarter. The decline in Q3 revenue was driven by the latest LOE products, chiefly Revlimid, and impacts from foreign exchange. In-line products, namely Eliquis and Opdivo, as well as the latest product portfolio including Opdualag, Abecma and Reblozyl partially offset the decline in revenues.
pharmaphorum
OCTOBER 26, 2022
Less than a week before Ipsen’s palovarotene was due to go in front of an FDA advisory committee, the meeting has been called off following a request by the regulator for more data. It’s the latest twist in the turbulent tale of the ultra-rare disease therapy – developed to treat genetic disorder fibrodysplasia ossificans progressiva (FOP) – which has seen progress to the US market held up by a series of clinical and regulatory obstacles.
Vodori
OCTOBER 26, 2022
Life science companies need to be able to move fast during the PRC review and approval process. You need to get a constant stream of relevant content to key audiences while being able to rapidly pivot to meet a new audience, respond to new data, to hone or shift their messaging and maintain a direct level of communication with customers while maintaining a consistent brand voice.
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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
Clarivate
OCTOBER 26, 2022
The world’s sustainability challenges provided the impetus for our new report, A study of energy in transition: the role of research and innovation in the world’s shift to sustainable energy sources. Through this report, we produce new insights to enlighten and empower all stakeholders – governments, corporations and society – and drive meaningful sustainability impact today and for the future.
PharmaTech
OCTOBER 26, 2022
Thursday October 27, 2022 at 11am ET | 10am CT | 8am PT When it comes to freely accessing and sharing lab data, there’s a lot working against you out there. To create infrastructure that truly mobilizes your data and modernizes your lab, you need a new kind of solution.
European Pharmaceutical Review
OCTOBER 26, 2022
A novel targeted radionuclide therapy candidate for malignant glioblastoma, LuCaFab (ITM-31), will be licensed to ITM Isotope Technologies Munich SE (ITM), a German radiopharmaceutical firm. ITM will hold exclusive rights to LuCaFab, including Intellectual Property patent, use and manufacturing knowledge. The licence is based on option and co-operation agreements announced in January 2022, which aimed to advance the therapeutic into clinical development. .
LEVO Health
OCTOBER 26, 2022
The medical device market is more saturated than you might think. With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need a marketing strategy that sets your medical device apart from the competition. How? You need to be more than a medical device company.
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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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