Bio Pharma Dive
AUGUST 14, 2023
Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.
Pharmaceutical Technology
AUGUST 14, 2023
HebeCell has forged a strategic collaboration with Logomix for researching and developing gene-edited natural killer cells (NK cells).
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Bio Pharma Dive
AUGUST 14, 2023
Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
Pharmaceutical Technology
AUGUST 14, 2023
Daxxify becomes the latest botulinum toxin to make the jump from aesthetics to therapeutics.
Bio Pharma Dive
AUGUST 14, 2023
Meet the pharma marketer of the future, primed for personalization and powered by technology.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 14, 2023
The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […]
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 14, 2023
There’s a whole world inside your gut, made up of mostly harmless microbes that reside in the gastrointestinal tract.
Bio Pharma Dive
AUGUST 14, 2023
The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.
Pharmaceutical Technology
AUGUST 14, 2023
The funding will extend support to the Institute’s Crick Africa Network for five years, supporting African scientists in infectious disease research.
Bio Pharma Dive
AUGUST 14, 2023
The agency approved Akeega only for patients with a BRCA mutation — another limited clearance for a class of drugs that have come under regulatory scrutiny.
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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
AUGUST 14, 2023
We discuss why demand for ionizable lipid mixes for delivery and target validation has surged and how the regulatory approval process is evolving.
Bio Pharma Dive
AUGUST 14, 2023
The $150 million in fresh funds will help Taysha keep the lights on well into 2025 and support testing of an experimental gene therapy for Rett syndrome.
Pharmaceutical Technology
AUGUST 14, 2023
Zetagen Therapeutics raised $9.79m in a Series B funding round to develop treatments for metastatic cancers to bone and soft tissue organs.
Bio Pharma Dive
AUGUST 14, 2023
The regulator has asked for documents tied to the 2021 deal as well as to the conduct and compensation of Illumina and Grail management.
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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
AUGUST 14, 2023
ImPact Biotech entered into a partnership with Maastricht University to develop a therapy for arresting pathologic myopia progression.
BioPharma Reporter
AUGUST 14, 2023
Teknova, a producer of life science reagents, has opened a new GMP-certified production facility which it claims will enable bioprocessing and gene therapy companies to get into the clinic faster.
Pharmaceutical Technology
AUGUST 14, 2023
Novartis obtains two Phase III drugs, atrasentan and zigakibart, and Chinook is eligible for an additional $300m in future payments.
Fierce Pharma
AUGUST 14, 2023
Just four years into the rollout of Pfizer's pricey heart medication Vyndamax, the company is already playing patent defense against a potential copycat. | Along with the Scripps Research Institute, the drug giant claims the proposed copycat would step on a Pfizer patent and two Scripps patents.
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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.
Pharmaceutical Technology
AUGUST 14, 2023
vTv plans to initiate a Phase III study for cadisegliatin with an FDA-recommended primary endpoint by the end of 2023.
XTalks
AUGUST 14, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. This includes patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, which can include a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Pharmaceutical Technology
AUGUST 14, 2023
The FDA has granted approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s AKEEGA for mCRPC.
Fierce Pharma
AUGUST 14, 2023
As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers such as Bristol Myers Sq | As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers like Bristol Myers Squibb and Emergent BioSolutions haven’t been immune. Now, Thermo Fisher Scientific is among the latest to plot hundreds of job cuts.
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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.
Pharmaceutical Technology
AUGUST 14, 2023
The PDUFA date has been pushed by three months to November to allow for more time for Phase IV activities.
BioSpace
AUGUST 14, 2023
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.
Pharmaceutical Technology
AUGUST 14, 2023
New advancements in cold chain monitoring are poised to revolutionise the pharmaceutical industry
Pharma Times
AUGUST 14, 2023
IDEAL study aims to determine the impact of seladelpar on alkaline phosphatase levels - News - PharmaTimes
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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.
BioSpace
AUGUST 14, 2023
Following its Scorpion Capital controversy in March, Harmony Biosciences is seeking to deepen its pipeline with an acquisition of Zynerba Pharmaceuticals’ cannabinoid therapies for neuropsychiatric disorders.
Fierce Pharma
AUGUST 14, 2023
Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. | Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s Zytiga and niraparib.
BioSpace
AUGUST 14, 2023
On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
Fierce Pharma
AUGUST 14, 2023
After debuting in the aesthetics market with Daxxify last year, Revance has made its way to the potentially lucrative therapeutic space. | Daxxify snagged its first therapeutic indication with Monday's FDA nod to treat cervical dystonia in adults. The green light comes a little less than a year after the Revance injection’s initial approval for temporary improvement of glabellar lines, or frown lines.
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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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