Fierce Pharma
OCTOBER 5, 2023
Merck’s Keytruda is riding a winning streak in bladder cancer. | Merck’s Keytruda is riding a winning streak in bladder cancer. Following FDA approvals in the metastatic and non-muscle invasive settings, the anti-PD-1 therapy has delivered a positive readout in muscle-invasive urothelial carcinoma.
Pharmaceutical Commerce
OCTOBER 5, 2023
In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.
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Fierce Pharma
OCTOBER 5, 2023
Mirati Therapeutics enjoyed a stock-price spike Thursday after rumors started swirling about a potential buyout by French drug giant Sanofi. | Mirati Therapeutics saw its stock price spike Thursday at the possibility of a buyout from Sanofi. The French pharma has been evaluating a potential acquisition of the KRAS drug developer, Bloomberg reports, citing unnamed sources.
MedCity News
OCTOBER 5, 2023
Cigna recently agreed to pay $172 million to resolve allegations that it violated the False Claims Act. One expert said this is just a small part of the problem, while another called for more clarity from the government.
Fierce Pharma
OCTOBER 5, 2023
The abrupt departure of Lonza’s CEO last month clearly hasn’t dampened the Swiss CDMO’s dealmaking prowess. | Lonza has extended a long-term collaboration with an unnamed “major global biopharmaceutical partner” to crank up commercial supply of antibody-drug conjugates at its site in Visp, Switzerland. The deal is set to boost Lonza’s current bioconjugation capacity fourfold, thanks to the addition of two new bioconjugation suites.
MedCity News
OCTOBER 5, 2023
In response to the urgent need for support, the federally funded National Maternal Mental Health Hotline was launched in 2022, In its first year, the hotline for new and expectant parents received more than 12,000 calls and texts, underlining the depth of the crisis affecting millions of Americans. For decades, the emotional highs and lows after giving birth were dismissed as simply “the baby blues.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 5, 2023
As we navigate the challenges of drug shortages, especially vital medications like Adderall, it’s crucial to be proactive. Predictive analytics, coupled with a deep understanding of alternative drugs, can guide our path forward.
Fierce Pharma
OCTOBER 5, 2023
Takeda will withdraw lung cancer drug Exkivity after a confirmatory trial failure. Kyowa Kirin is buying gene therapy biotech Orchard Therapeutics. | Takeda will withdraw lung cancer drug Exkivity after a confirmatory trial failure. Kyowa Kirin is buying gene therapy biotech Orchard Therapeutics. Biogen's biosimilar version of Roche's Actemra, bought from Bio-Thera Solutions, won an FDA nod.
MedCity News
OCTOBER 5, 2023
The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.
Fierce Pharma
OCTOBER 5, 2023
This discussion interviews Harshit Jain, a physician turned entrepreneur and founder of Doceree, a company solving healthcare professional marketing challenges focused on pharmaceuticals. | The role of digital marketing and data utilization in pharma marketing is growing along with the need for a holistic approach to engage HCPs effectively.
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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
OCTOBER 5, 2023
Headway closed a $125 million Series C funding round. The round brings the New York-based startup’s valuation to $1 billion, reaching unicorn status. The company connects patients to in-network therapists and helps mental health providers avoid the massive administrative burden associated with taking insurance.
Fierce Pharma
OCTOBER 5, 2023
Five weeks removed from slashing 25% of its workforce amid problems wi | Five weeks removed from slashing 25% of its workforce amid problems with its groundbreaking geographic atrophy drug, Apellis is making progress in re-accelerating the launch of Syfovre. Ahead of its quarterly earnings presentation, Apellis estimated sales of approximately $74 million for the third quarter for Syfovre and a rekindling of demand in recent weeks as doctors get a better handle on the risk of vascular retinitis.
MedCity News
OCTOBER 5, 2023
What does the future hold with AI and the healthcare ecosystem? Camille Harrison with GuideWell, Florida Blue joins the Payer’s Place to share her thoughts.
Fierce Pharma
OCTOBER 5, 2023
Judgment Day has come for Amgen’s first-in-class KRAS inhibitor Lumakras as the FDA’s Oncologic Drugs Advisory Committee (ODAC) gathered Thursday to weigh the merits of the cancer med’s phase 3 cli | Judgment Day has come for Amgen’s first-in-class KRAS inhibitor Lumakras as the FDA’s Oncologic Drugs Advisory Committee gathered Thursday to weigh the merits of the cancer med’s phase 3 clinical trial CodeBreak 200.
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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 5, 2023
Investment trends will be a big theme at the HLTH event at the Las Vegas Convention Center October 8-11. In the runup to the conference, investors from Bessemer Venture Partners, Cleveland Clinic Innovations, Third Culture Capital and Intuitive Ventures offered their takes on 2023 investments.
Fierce Pharma
OCTOBER 5, 2023
In this episode of "The Top Line," we delve into the uncharted territory that pharma marketers face, from harnessing AI's potential to navigating the Inflation Reduction Act. | In this episode of "The Top Line," we delve into the uncharted territory that pharma marketers face, from harnessing AI's potential to navigating the Inflation Reduction Act.
MedCity News
OCTOBER 5, 2023
Through a partnership with Mount Sinai Solutions, Instacart is offering post-operative and post-partum patients a grocery stipend. Instacart is also launching co-branded Medicare Advantage plans with Alignment Healthcare that address food insecurity issues for seniors.
Fierce Pharma
OCTOBER 5, 2023
In this interview, George Griffith, Executive Vice President of Omnichannel Strategy at Relevate Health and founder of ConneXion360 (acquired by Relevate Health), emphasizes his commitment to educa | Data integration and precision in pharma marketing enhances the customer experience and builds brand loyalty
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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 5, 2023
Maja Pedersen has been appointed as Chief Quality Officer (CQO), to lead FUJIFILM Diosynth Biotechnologies’ global quality team. Pedersen’s new role is effective immediately. As a member of the executive leadership team, she will report to President and CEO Lars Petersen, who was appointed in June this year. With 20 years of leadership experience in the life sciences and biopharma sector, Pedersen has previously had senior leadership positions in quality assurance (QA) and quality control ( QC )
MedCity News
OCTOBER 5, 2023
Diana Health, which partners with hospitals to operate a network of maternity practices, closed a $34 million Series B funding round. The startup currently operates three women’s health practices in Tennessee. With its new funding, the company plans to open new practices in Tennessee, Florida and one other yet-to-be-announced state.
European Pharmaceutical Review
OCTOBER 5, 2023
Longeveron’s Phase IIa trial of its stem-cell therapy for mild Alzheimer’s has revealed in top-line results, that certain doses enabled numerical slowing/prevention of disease worsening relative to placebo. According to Longeveron who developed the treatment, Lomecel-B is a living cell product made from mesenchymal stromal cells (MSCs) isolated from the bone marrow donors.
Pharmaceutical Technology
OCTOBER 5, 2023
Lumicell co-founder, Moungi Bawendi, has been awarded the accolade alongside two others for his research into quantum dots.
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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 5, 2023
Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner. What are the key topics you plan to cover during your session at CPHI Barcelona?
PharmaTimes
OCTOBER 5, 2023
The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes
PharmaTech
OCTOBER 5, 2023
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
PharmaTimes
OCTOBER 5, 2023
It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes
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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 Commerce
OCTOBER 5, 2023
LogiPharma session reminds attendees of what to review, as far as DSCSA compliance is concerned.
Clarivate
OCTOBER 5, 2023
Clarivate hosted a panel discussion focused on advances in transparent peer review that can help mitigate some of the challenges around peer review manipulation. Trust is central to a functional research system, as it is to a functional society at large. However, a variety of threats to research integrity have been growing, including paper mills, image manipulation and the potential for AI abuse.
Pharmaceutical Commerce
OCTOBER 5, 2023
Panel discusses how digital transformation can best impact supply chains.
PharmExec
OCTOBER 5, 2023
Company expects treatment to be available across the country.
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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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