Drug Patent Watch
SEPTEMBER 18, 2024
The biopharmaceutical industry is constantly evolving, with the demand for complex biologics on the rise. To stay competitive, companies must navigate the complexities of biopharmaceutical development while managing costs effectively. One key strategy for achieving this balance is partnering with Contract Development and Manufacturing Organizations (CDMOs).
Pharmaceutical Technology
SEPTEMBER 18, 2024
Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.
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AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 18, 2024
(Niklas Hamann/Unsplash) Most of us will be all too familiar with that dopey, groggy feeling of being tired after a restless night. Some social media users have taken tiredness to the extreme, however, by taking part in what they call a “no-sleep challenge.
Pharmaceutical Technology
SEPTEMBER 18, 2024
Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.
Rethinking Clinical Trials
SEPTEMBER 18, 2024
Dr. John Fortney In this Friday’s PCT Grand Rounds, John Fortney of the University of Washington will present “Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.” The Grand Rounds session will be held on Friday, September 20, 2024, at 1:00 pm eastern. Fortney is a professor of psychiatry and behavioral sciences in the University of Washington School of Medicine and a senior research career scientist in the HSR Center of Innovat
Bio Pharma Dive
SEPTEMBER 18, 2024
The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 18, 2024
At the Clinical Trial Supply West Coast 2024 conference, serial biotech entrepreneur Umar Hayat said science should be allowed to advance without political interference.
Bio Pharma Dive
SEPTEMBER 18, 2024
The deal hands Organon a psoriasis and eczema cream called Vtama, while Roivant will get more cash to fund its R&D plans.
Pharmaceutical Technology
SEPTEMBER 18, 2024
Ossium Health’s PRESERVE I trial is evaluating the safety and effectiveness of its deep-frozen bone marrow from deceased organ donors.
Fierce Pharma
SEPTEMBER 18, 2024
With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.
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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 18, 2024
Nura Bio has secured additional $68m in a Series A financing round to advance the development of its neuroprotective therapies.
Fierce Pharma
SEPTEMBER 18, 2024
This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.
Pharmaceutical Technology
SEPTEMBER 18, 2024
Orbis Medicines and Vivtex have partnered to support the development of next-generation orally dosable macrocycle drugs.
Fierce Pharma
SEPTEMBER 18, 2024
Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.
pharmaphorum
SEPTEMBER 18, 2024
PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted
Fierce Pharma
SEPTEMBER 18, 2024
Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could | Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.
pharmaphorum
SEPTEMBER 18, 2024
In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.
XTalks
SEPTEMBER 18, 2024
World Alzheimer’s Day, observed annually on September 21, unites the global community to raise awareness and challenge the stigma surrounding Alzheimer’s disease. The theme of World Alzheimer’s Day 2024 is “Time to Act on Dementia, Time to Act on Alzheimer’s.” This theme will reflect ongoing efforts to ensure that individuals living with dementia, their caregivers and their families are supported.
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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.
pharmaphorum
SEPTEMBER 18, 2024
Novartis' Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over rival Verzenio from Eli Lilly
BioPharma Reporter
SEPTEMBER 18, 2024
Alison has more than 35 years of broad experience delivering clinical trials to sponsors with a patient centric mindset.
Pharma Times
SEPTEMBER 18, 2024
It is hoped that the tool will improve the diagnostic pathway and free up radiologists’ time
FDA Law Blog
SEPTEMBER 18, 2024
By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provides that a dietary supplement does not include: (i) an article that is approved as a new drug under section 355 of [the FDC Act], certified as an antibiotic under section 357 of [the FD
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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
Pharma Times
SEPTEMBER 18, 2024
The conference will return to Vienna AirportCity on 23 to 24 October 2024
BioPharma Reporter
SEPTEMBER 18, 2024
The Swedish biotech company Cellevate has raised â3.2 million in a seed round to fuel the commercialization of its nanofiber-based viral vector manufacturing technology in November.
Drug Discovery World
SEPTEMBER 18, 2024
Scientists have discovered that a protein linked to prostate cancer is associated with more aggressive disease and could be a new target for treatment. The team at The Institute of Cancer Research, London, UK, have shown that the BCL2 protein was abundant in a subtype of advanced prostate cancer which has stopped responding to hormone therapy. The researchers estimate that around 10% of people with prostate cancer have high levels of this protein.
pharmaphorum
SEPTEMBER 18, 2024
Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.
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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.
BioPharma Reporter
SEPTEMBER 18, 2024
MinervaX and Wacker Biotech announced yesterday that they have entered into a manufacturing agreement for MinervaXâs prophylactic vaccine against Group B Streptococcus infections.
Fierce Pharma
SEPTEMBER 18, 2024
Authors: | Unlock the potential of patient support data with effective information governance. Manage risks, ensure compliance, and drive innovation for better patient outcomes.
pharmaphorum
SEPTEMBER 18, 2024
Explore the high cost of inequality in the US healthcare system and why despite the significant spending, it falls short in delivering adequate services and outcomes. Gain insights into the challenges and potential solutions.
Drug Discovery World
SEPTEMBER 18, 2024
CDR-Life has announced new developments to its programme of antibody-based T cell engagers (TCE) targeting intracellular tumour antigens MAGE-A4 and PRAME via the major histocompatibility complex. The first patient has been dosed with CDR404, a novel, bispecific and bivalent antibody fragment-based TCE targeting MAGE-A4. MAGE-A4 is an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells.
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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.
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