pharmaphorum
MARCH 21, 2024
On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.
Bio Pharma Dive
MARCH 21, 2024
The job cuts at the cancer drug developer will primarily impact manufacturing roles, but will touch on several other parts of the organization, the company said.
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Pharmaceutical Technology
MARCH 21, 2024
Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.
Bio Pharma Dive
MARCH 21, 2024
The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.
Pharmaceutical Technology
MARCH 21, 2024
Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.
Bio Pharma Dive
MARCH 21, 2024
The financing for the startup, which is led by former executives of a biotech Merck recently bought for nearly $11 billion, is the sector’s largest for a privately held company this year.
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
MARCH 21, 2024
Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.
Pharmaceutical Technology
MARCH 21, 2024
Capstan Therapeutics has secured $175m Series B financing to advance its lead in vivo CAR-T candidate, CPTX2309, for autoimmune disorders.
Bio Pharma Dive
MARCH 21, 2024
Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.
Pharmaceutical Technology
MARCH 21, 2024
Biotech executives discuss why developing gene therapies for central nervous system disorders remains difficult at a recent conference.
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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
Rethinking Clinical Trials
MARCH 21, 2024
The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.
Bio Pharma Dive
MARCH 21, 2024
The executive team will reportedly shrink from 14 to eight in the latest step in new CEO Bill Anderson’s plan to slash management and reduce “bureaucracy” at the healthcare conglomerate.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 21, 2024
India must now move towards looking to merge its Central and state enforcement wings and form a single authority. This will be a significant administrative reform.
Pharmaceutical Technology
MARCH 21, 2024
Lilly says that the FDA wants to look closer at efficacy implications of the Phase III donanemab trial design before giving the green light.
pharmaphorum
MARCH 21, 2024
There is no denying that artificial intelligence (AI) has captured the imagination of innovators working across the pharmaceutical sector. The drug discovery space is no different, with myriad applications promising to revolutionise the way that researchers and sponsors approach identifying and progressing new drug candidates.
Pharmaceutical Technology
MARCH 21, 2024
Lonza has agreed to acquire the Genentech large-scale biologics manufacturing facility in the US from Roche in a deal totalling $1.2bn.
BioSpace
MARCH 21, 2024
Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.
Pharmaceutical Technology
MARCH 21, 2024
Different therapeutic approaches against antibiotic-resistant bacteria were highlighted throughout day two of the ELRIG UK conference.
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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.
Pharma Times
MARCH 21, 2024
The globally fast-growing progressive neurological condition affects around 153,000 people in the UK
Pharmaceutical Technology
MARCH 21, 2024
Nouscom is part of a cancer vaccine landscape that has recently jump-started following years of dormancy.
pharmaphorum
MARCH 21, 2024
The rising demand for mono-material packaging in the pharmaceutical industry due to its sustainability benefits will have a significant impact. Learn more about how this trend is shaping the future of pharmaceutical packaging.
Pharmaceutical Technology
MARCH 21, 2024
Panellists discuss opportunities and challenges in cell and gene therapies at the Advanced Therapies conference in London, UK.
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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
pharmaphorum
MARCH 21, 2024
Clasp Therapeutics has burst onto the T-cell engager (TCE) scene with $150 million in funding for a platform that aims to improve the safety of the class, which is currently gaining traction in cancer immunotherapy.
Pharmaceutical Technology
MARCH 21, 2024
Deals involving research into molecular glues have skyrocketed this year as big pharma bets on their revolutionary potential.
XTalks
MARCH 21, 2024
The US Food and Drug Administration (FDA) has awarded approval to Orchard Therapeutics for its gene therapy Lenmeldy (atidarsagene autotemcel) for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy is the first and only FDA-approved gene therapy for children with these types of MLD.
Pharmaceutical Technology
MARCH 21, 2024
The Phase III KEYLYNK-006 study evaluating a Keytruda/Lynparza combination treatment failed to meet its primary endpoints.
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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
MARCH 21, 2024
A partnership between Eisai and Lifenet that aims to improve insurance cover for people with early dementia has generated its first policy, part of an effort by the pharma group to develop an ‘ecosystem’ to support patients.
Fierce Pharma
MARCH 21, 2024
Drug developers often try to spot tidbits of positive information from a failed clinical trial. | Drug developers often try to spot tidbits of positive information from a failed clinical trial. But Roche is doing the opposite for its positive Enspryng study in the competitive autoimmune disorder of myasthenia gravis.
pharmaphorum
MARCH 21, 2024
Surgeons in the US have carried out the world’s first transplant of a pig kidney into a human, a feat made possible by genetic modification of the organ and an experimental immunosuppressant drug regimen to prevent rejection. The recipient, 62-year-old Richard Slayman of Weymouth in Massachusetts, had end-stage renal disease and was dependent on dialysis.
BioPharma Reporter
MARCH 21, 2024
Since Roche's Zelboraf (vemurafenib)gained FDA approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma.
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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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