Fierce Pharma
JULY 21, 2023
If at first you don’t succeed, try, try again. That’s the lesson Daiichi Sankyo likely took home Friday after scoring a long-awaited U.S. | Some four years after Daiichi Sankyo's quizartinib scored its initial green light in Japan—and suffered a slap-down from drug regulators stateside—the acute myeloid leukemia medicine has won the FDA’s blessing.
MedCity News
JULY 21, 2023
What we need to overcome adherence challenges is a digitally enabled marketplace of options that can be personalized to the patient and the context of their specific condition, pharmacy preference and ability to pay.
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Fierce Pharma
JULY 21, 2023
A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether fol | After severe respiratory events and seven deaths held up ADC's Zynlonta study in unfit or frail patients with previously untreated diffuse large B-cell lymphoma, the company has scrapped the trial altogether.
MedCity News
JULY 21, 2023
Digital health startup Dorsata filed a lawsuit against EHR provider athenahealth and women’s health company Unified Women’s Healthcare. The startup alleged that athenahealth stole trade secrets, used deceptive business practices and breached its contract — and that Unified aided and abetted these purported practices.
Fierce Pharma
JULY 21, 2023
Catalent’s onerous year just got even more complicated. | Proxy battler and shareholder dissident Elliott Management has acquired a stake in Catalent in a bid to shuffle the drugmaker’s board, The Wall Street Journal reported Thursday. Elliott has been in talks with potential director candidates in an effort to build a Rolodex of nominees for a potential proxy contest, according to the news outlet.
European Pharmaceutical Review
JULY 21, 2023
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 21, 2023
The Treat and Reduce Obesity Act would expand Medicare coverage for obesity screenings, treatments and therapies like anti-obesity medications. The Health Equity Coalition for Chronic Disease came out in favor of the bill and asked for swift passage.
Fierce Pharma
JULY 21, 2023
In this episode of 'The Top Line' we replay an important show from April 28, 2023 regarding Narcan. | This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.
European Pharmaceutical Review
JULY 21, 2023
A semi-quantitative limulus amebocyte lysate (LAL) gel clot test with a narrow dilution range can be valuable for relatively accurate estimation of endotoxin in biopharmaceutical products, research shows. The paper published in Vaccine Research demonstrated the compatibility and benefits of LAL gel clot tests in a semi-quantitative manner compared to the LAL chromogenic assay.
Fierce Pharma
JULY 21, 2023
An approval from the U.S. | Friday, Mirati said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati “disagrees with the opinion” and intends to file for a formal re-examination, the company said.
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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.
European Pharmaceutical Review
JULY 21, 2023
To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. With this financial boost, the Ljubljana site is set to become a key location for biosimilar product development at Sandoz. “The new Biosimilar Development Center in Ljubljana will …[help] Sandoz
Pharmaceutical Commerce
JULY 21, 2023
The importance of industry, as it moves forward, in focusing on patient-centered care and prioritizing patient needs across the supply chain.
European Pharmaceutical Review
JULY 21, 2023
European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The US Food and Drug Administration (FDA) published its discussion paper on AI in drug development in May 2023, and now European regulators following a similar route to help chart a new course for this emerging technology.
Pharmaceutical Technology
JULY 21, 2023
Hutchmed has secured breakthrough therapy designation from China’s NMPA for fruquintinib and sintilimab combination to treat EMC.
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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
JULY 21, 2023
Independent primary care practices are at risk of extinction. The U.S. must re-dedicate itself to the preservation of independent primary care over the long run and must undergo a radical reorientation of the health system toward primary care.
Pharmaceutical Technology
JULY 21, 2023
While artificial intelligence (AI) in medical devices has regulatory boundaries, its use in a medicine’s life cycle is less clear.
MedCity News
JULY 21, 2023
Turnstone Biologics isn’t the only cell therapy biotech focused on tumor-infiltrating lymphocytes. With $80 million in IPO cash, it can continue clinical trials that could show whether its approach to TILs has advantages.
PharmExec
JULY 21, 2023
In this latest Harvard Business School Healthcare Alumni Association Q&A, JT Saunders, Chief Diversity Officer at global consulting firm Korn Ferry, discusses diversity in pharma, as well as what mentors and mentees should be considering in the workplace.
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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.
PharmaTimes
JULY 21, 2023
The inhaler supports appropriate individuals presenting with asthma and chronic obstructive pulmonary disease - News - PharmaTimes
Pharma Marketing Network
JULY 21, 2023
Google Ads is a powerful platform that can help pharma companies reach their target audience and achieve their marketing goals. However, in order to get the most out of Google Ads, it’s important to optimize your campaigns. Here are some tips for optimizing your Google Ads campaigns for the pharma industry: Set clear goals: Before you start optimizing your campaigns, it’s important to set clear goals for what you want to achieve.
PharmaTimes
JULY 21, 2023
Data underlines the significance of the company’s anti-GDF-15 antibody candidate, visugromab - News - PharmaTimes
Pharma Marketing Network
JULY 21, 2023
Facebook ad quality ranking is a measure of how relevant and engaging your ads are to your target audience. It is important for pharmaceutical companies to have high-quality ads because it can affect their ad delivery and performance. There are a number of factors that contribute to Facebook ad quality ranking, including: Relevance: Your ads should be relevant to your target audience.
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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.
Legacy MEDSearch
JULY 21, 2023
UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. This milestone indicates a new era for millions of women suffering from SUI, and results of this clinical study will contribute to the design and implementation of UroMems’ pivotal clinical trial in Europe and t
Pharma Marketing Network
JULY 21, 2023
LinkedIn is a powerful tool that can help you connect with potential employers, clients, and other professionals in the pharmaceutical industry. But in order to get the most out of LinkedIn, you need to know a few tips and tricks that are specific to the pharmaceutical industry. Here are some expert LinkedIn tips and tricks for the pharmaceutical industry: Complete your profile: Your profile is the first thing that potential connections will see, so make sure it’s complete and up-to-dat
LEVO Health
JULY 21, 2023
Patient reactivation is not just about bringing back old patients — it’s about reestablishing trust and rekindling relationships. It’s also about strategic data analysis, proactive outreach, and persuasive retargeting. At Levo Health, we integrate innovative marketing strategies with healthcare expertise to revitalize these essential relationships to drive patient engagement.
Pharma Marketing Network
JULY 21, 2023
Sponsorships can be a powerful tool for pharmaceutical companies to engage with communities and make a positive impact on health and wellness. When done right, sponsorships can help pharmaceutical companies connect with their target audience, build relationships with key stakeholders, and promote their brand in a meaningful way. Here are some examples of how pharmaceutical companies can use sponsorships to engage communities: Sponsoring community health events: Pharmaceutical companies can s
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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
Pharmaceutical Technology
JULY 21, 2023
In the global pharmaceutical industry, there were 7 private equity deals announced in Q2 2023, worth a total value of $535.3m, according to GlobalData's Deals Database.
PharmaTech
JULY 21, 2023
Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.
Pharmaceutical Technology
JULY 21, 2023
Other forms of immunotherapy have progressed rapidly in recent years, but oncolytic viruses remain restricted to the early stages of development.
PharmaTech
JULY 21, 2023
The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.
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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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