Bio Pharma Dive
SEPTEMBER 6, 2023
Jane Grogan, an industry veteran who worked at Genentech for over 15 years, will take over the role starting Oct. 2. She’ll fill a seat that's lacked a permanent replacement since the departure of Al Sandrock.
Pharmaceutical Technology
SEPTEMBER 6, 2023
The UK MHRA has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.
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Bio Pharma Dive
SEPTEMBER 6, 2023
The decision is the latest in a series of setbacks for the Actelion spinout and ends a lucrative partnership that began in 2017.
Pharmaceutical Technology
SEPTEMBER 6, 2023
The US FDA has requested that AstraZeneca make modifications to the Ultomiris REMS programme to approve a label expansion.
Bio Pharma Dive
SEPTEMBER 6, 2023
The Boston biotech has sold two experimental drugs — a liver disease medicine and a TYK2 inhibitor — to Gilead and Takeda respectively.
Pharma Mirror
SEPTEMBER 6, 2023
by Nataliya Andreychuk, Co-founder and CEO of Viseven Many pharma brands still shy away from marketing directly to patients, depending on conversion through healthcare providers (HCPs). And it is not hard to see why. Compliance with complex laws and regulations, like Direct-to-Consumer Advertising (DTCA) Rules or the Health Insurance Portability and Accountability Act (HIPAA), can be quite daunting.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 6, 2023
Sandoz, the generics division of Novartis, has underperformed in recent years, but the spin-off may not settle investors.
Fierce Pharma
SEPTEMBER 6, 2023
IBM disclosed "unauthorized access" to J&J’s Janssen CarePath patient assistance program, which helped over 1 million U.S. patients last year.
Pharmaceutical Technology
SEPTEMBER 6, 2023
Zenas BioPharma and BMS have signed an agreement for the development and commercialisation of obexelimab to treat autoimmune ailments.
XTalks
SEPTEMBER 6, 2023
This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
SEPTEMBER 6, 2023
AstraZeneca is working with its collaborators to ensure the changes are not just internal but across the entire chain footprint.
Pharma Times
SEPTEMBER 6, 2023
Therapy is used among adult patients with symptomatic obstructive hypertrophic cardiomyopathy - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 6, 2023
TC BioPharm and QMUL have announced a partnership to study gamma-delta T cells potential for treating mucosal infections.
Pharma Times
SEPTEMBER 6, 2023
Technology combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion - News - PharmaTimes
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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
SEPTEMBER 6, 2023
Mirum Therapeutics acquired Travere’s Cholbam and Chenodal drugs that are approved to treat rare disorders.
Fierce Pharma
SEPTEMBER 6, 2023
Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). | Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act. But now that the Centers for Medicare & Medicaid Services has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation.
Pharmaceutical Technology
SEPTEMBER 6, 2023
Amid financial issues, Idorsia is hoping the resistant hypertension drug would boost the company’s profits.
XTalks
SEPTEMBER 6, 2023
As PepsiCo, Inc. positions itself at the forefront of digital advancements, the company recently declared its intention to purchase $175 million of Instacart’s Series A preferred convertible stock. This pivotal move was revealed alongside Instacart’s Form S-1 filed on August 25 with the Securities and Exchange Commission (SEC), indicating plans for its much-anticipated initial public offering (IPO) — the Instacart IPO date.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fierce Pharma
SEPTEMBER 6, 2023
AstraZeneca’s Ultomiris expansion plan has hit a snag in the U.S. | The FDA handed the company a complete response letter for its Ultomiris application in neuromyelitis optica spectrum disorder, a rare autoimmune disease affecting the central nervous system.
CTTI (Clinical Trials Transformation Initiative)
SEPTEMBER 6, 2023
Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health.
Fierce Pharma
SEPTEMBER 6, 2023
Johnson & Johnson’s Rybrevant is currently approved for a tiny non-small cell lung cancer (NSCLC) niche. | Johnson & Johnson’s Rybrevant is currently approved for a tiny non-small cell lung cancer niche. A late-stage study could move the drug to a larger disease area where AstraZeneca’s blockbuster Tagrisso plays, but the most important readout still lies ahead.
Pharmaceutical Commerce
SEPTEMBER 6, 2023
Stakeholders uncover the obstacles surrounding the industry onboarding process.
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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.
Fierce Pharma
SEPTEMBER 6, 2023
Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial offic | Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial officer title.
Pharma Marketing Network
SEPTEMBER 6, 2023
“Artificial Intelligence” (AI) is certainly experiencing the shiny object spotlight in 2023. In all industries, the “what if’s” around the use of AI range from massive upsides in efficiency to looming downsides of impending elimination of entire teams. At the DHC Group, our goal to help shape the future of digital health means we focus on upcoming challenges and industry advancements, and provide insights to help prepare decision makers for the evolving digital health landscape.
Fierce Pharma
SEPTEMBER 6, 2023
Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. | Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues. Meanwhile, the company's Skytrofa is going up against a new competitor in Pfizer and OPKO Health's Ngenla.
Drug Discovery World
SEPTEMBER 6, 2023
Phesi, a global provider of patient-centric data software and services, has partnered with Krystelis, a provider of medical writing and clinical trial transparency services, to launch its new Diversity, Equity, and Inclusion (DEI) Data Service. A 2022 Phesi data analysis discovered 42% of US cancer trial cohorts do not include African American patients, and almost half – 48% – have no Hispanic American patients.
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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.
pharmaphorum
SEPTEMBER 6, 2023
FDA starts review of Roche's PNH drug crovalimab Phil.
Drug Channels
SEPTEMBER 6, 2023
CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. Here’s the press release: CVS Health Launches Cordavis.
pharmaphorum
SEPTEMBER 6, 2023
Why pharmacies are turning to route optimisation Mike.
Pharma Marketing Network
SEPTEMBER 6, 2023
“Artificial Intelligence” (AI) is certainly experiencing the shiny object spotlight in 2023. In all industries, the “what if’s” around the use of AI range from massive upsides in efficiency to looming downsides of impending elimination of entire teams. At the DHC Group, our goal to help shape the future of digital health means we focus on upcoming challenges and industry advancements, and provide insights to help prepare decision makers for the evolving digital health landscape.
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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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