Pharmaceutical Technology
FEBRUARY 9, 2024
Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.
Bio Pharma Dive
FEBRUARY 9, 2024
Shortly after Kyverna priced one of the sector’s largest IPOs in recent years, Maag spoke with BioPharma Dive about what it takes to go public now.
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Pharmaceutical Technology
FEBRUARY 9, 2024
AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for FY 2023 from $3.29bn in the previous year.
Bio Pharma Dive
FEBRUARY 9, 2024
New results have convinced Takeda to “rapidly” pursue a late-stage program for its drug TAK-861 in one type of narcolepsy, while in another the company opted not to continue.
Pharmaceutical Technology
FEBRUARY 9, 2024
Boehringer has entered a strategic collaboration with CBmed to expedite the translation of cancer treatment approaches into new therapies.
pharmaphorum
FEBRUARY 9, 2024
Learn how implementing a SMART approach in stem cell manufacturing can lead to improved efficiency and cost reduction for the production of mesenchymal stem cells (MSCs) used in the treatment of osteoarthritic and autoimmune conditions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 9, 2024
The combination of drugs for hypertension and software to personalise dosing to an individual patient has been shown to deliver improved blood pressure control and adherence to therapy in a pilot study.
Pharmaceutical Technology
FEBRUARY 9, 2024
Novo Nordisk’s plans to buy Catalent has raised objections related to the risk of drug shortages, manufacturing standards, and antitrust violations.
FDA Law Blog
FEBRUARY 9, 2024
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ).
Pharmaceutical Technology
FEBRUARY 9, 2024
BioNTech has entered into a strategic partnership with Autolus Therapeutics to progress the development of CAR-T cell therapy programmes.
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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 Commerce
FEBRUARY 9, 2024
Researchers explore the proportion of approved drugs in the Canadian marketplace that utilize manufacturer-sponsored patient support programs, along with the types of medications that are more likely to do so.
Pharmaceutical Technology
FEBRUARY 9, 2024
The Phase I trial for evaluating Hemogenyx’s CAR-T therapy to treat acute myeloid leukaemia has been cleared to begin in the US.
pharmaphorum
FEBRUARY 9, 2024
Measuring the success or failure of UK MedTech companies is complex and multi-faceted, but it is undoubtedly influenced by two significant factors. Read on to learn more.
Pharmaceutical Technology
FEBRUARY 9, 2024
The survey by CRO Worldwide Clinical Trials shows that pharma and biotechs favour midsize CROs due to the personalised service.
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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
Drug Discovery World
FEBRUARY 9, 2024
Catalent and Novo Holdings, a holding and investment company that manages the assets and wealth of the Novo Nordisk Foundation, have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion. Novo Holdings will acquire all outstanding shares of Catalent for $63.50 per share in cash.
Pharmaceutical Technology
FEBRUARY 9, 2024
Janssen has filed a Type II extension of indication application with the EMA seeking approval for Rybrevant for NSCLC.
Pharma Times
FEBRUARY 9, 2024
The rare neurodevelopmental condition CDKL5 is characterised by early-onset epilepsy
Pharmaceutical Technology
FEBRUARY 9, 2024
Philips' has recalled a number of high profile medical devices in recent years, shaking investor confidence.
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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
FEBRUARY 9, 2024
Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday. | Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday.
Pharmaceutical Commerce
FEBRUARY 9, 2024
A dive into the intricacies of how to ensure a long-running event stays fresh and relevant to the needs of the pharmaceutical industry.
Fierce Pharma
FEBRUARY 9, 2024
A year into a dire shortage of essential cancer medicines in the U.S., the American Society of Clinical Oncologists (ASCO) is again pushing Congress to act to end the crisis. | The oncology drug supply crisis has entered its second year, and doctors still face "impossible choices" without access to standard-of-care therapies, ASCO's chief medical officer, Dr.
pharmaphorum
FEBRUARY 9, 2024
Discover insights from Trevor Martin, the co-founder and CEO of Mammoth Biosciences, in an exclusive interview from JP Morgan for 2024. Gain valuable knowledge about Mammoth Biosciences and the future of biotech innovation.
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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
FEBRUARY 9, 2024
As Catalent gets ready to join the Novo fold, the contract manufacturing juggernaut continues to slide on its diminishing COVID-19 business. | Despite some turbulence at Catalent, including an 11% sales drop for the quarter, investors still seem to be buzzed about the stock after this week’s announcement that Novo Holdings is buying out the CDMO for $16.5 billion.
Pharma Times
FEBRUARY 9, 2024
OART is increasingly emerging to assess and adapt treatment for cancer patients
Drug Channels
FEBRUARY 9, 2024
Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir shares findings from CareMetx’s new 2024 Patient Services Report research study: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage. As he explains, manufacturers want hub partners that can take a holistic approach and address each patient’s individual needs.
XTalks
FEBRUARY 9, 2024
With the frenzy around Ozempic (semaglutide) not stopping any time soon, maker Novo Nordisk has been fielding calls from junk food suppliers with concerns about how the blockbuster diabetes and weight loss version of the drug, Wegovy (semaglutide), could potentially make a dent in their businesses. Novo CEO Lars Fruergaard Jørgensen told Bloomberg that he’s been receiving calls from the “scared” bosses of food companies who are feeling threatened by the current new weight loss culture driven by
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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.
Drug Patent Watch
FEBRUARY 9, 2024
Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. It is available from two suppliers. There are eighteen patents protecting… The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.
XTalks
FEBRUARY 9, 2024
International Epilepsy Day, observed annually on the second Monday of February, serves as a pivotal occasion to increase awareness of epilepsy. This global initiative, coordinated by the International Bureau for Epilepsy (IBE) and the International League Against Epilepsy (ILAE), offers a platform for individuals with epilepsy to share their stories and experiences with a worldwide audience.
Sciensano
FEBRUARY 9, 2024
Diagnostic and surveillance of infectious diseases Event type: symposium Audience: health professionals scientists specialist in clinical biology university staff Description: Organised by Sciensano, under the auspices of the Belgian Association for Public Health ( BAPH ). Sciensano organises each year a scientific seminar about “Diagnostic and surveillance of infectious diseases”.
XTalks
FEBRUARY 9, 2024
Recent years have seen significant advancements and shifts in the therapeutic approaches to one of the world’s leading health concerns: cardiovascular diseases. As we delve into the top 15 cardiovascular disease drugs in 2023, guided by comprehensive 2022 sales data, we gain valuable insights into the market trends, drug efficacy and the evolving needs of patients worldwide.
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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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