Bio Pharma Dive
JUNE 6, 2022
The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment.
World of DTC Marketing
JUNE 6, 2022
Medicare Advantage plans are endangering the lives of older adults and people with disabilities. The HHS Office of the Inspector General (OIG), which works to fight waste, fraud, and abuse, recently issued a devastating report showing that these corporate health plans, which contract with the government to deliver Medicare benefits, are denying large amounts of care inappropriately. .
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Bio Pharma Dive
JUNE 6, 2022
The stem cell therapy company said the restructuring is meant as a first step toward making it "more attractive" to potential financial and strategic partners.
pharmaphorum
JUNE 6, 2022
American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . US drug prices have soared over the last several decades, causing, at times, financial hardship for patients and their families, so Cuban says he developed MCCPDC with a simple mission – “to be the low-cost provider of medications to patients.”.
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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
Bio Pharma Dive
JUNE 6, 2022
Real-world data (RWD) and real-world evidence (RWE) are coming into increasingly widespread use across the entire pharmaceutical product development lifecycle.
pharmaphorum
JUNE 6, 2022
Shares in Praxis Precision Medicines were in freefall today after the company’s efforts to develop a new therapy for major depressive disorder (MDD) ended in failure, forcing a restructuring and staff cuts. The selloff followed the announcement of the phase 2/3 Aria study results with PRAX-114 as a monotherapy for MDD, which showed the GABA positive allosteric modulator was unable to show a significant benefit on any of the study’s primary and secondary endpoints.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 6, 2022
Eversana’s suite of commercialisation tools for pharma companies will soon have a new component – cognitive behavioural training tools designed to improve the performance of sales representatives. The addition to the company’s portfolio – which already spans services like patient support, digital engagement, dispensing and distribution, and data/analytics – has arrived on the back of an alliance with business and wellness coaching specialist Limitless Minds.
Bio Pharma Dive
JUNE 6, 2022
After recently announcing plans to eliminate more than half its staff, the biotech now intends to sell its research programs to Janssen and enter a reverse merger with the private company Kineta.
pharmaphorum
JUNE 6, 2022
In February, AstraZeneca and Daiichi Sankyo teased the results of their pivotal trial of Enhertu in HER2-low breast cancer, and, at ASCO, they finally revealed the data – with the numbers every bit as good as hoped. The top-line results of DESTINY Breast-04 are impressive – in patients with HER2-low metastatic breast cancer who received multiple lines of prior treatment, Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or death by 49%, whilst improving overall survi
BioSpace
JUNE 6, 2022
Results of a Phase II/III study showed that patients who were given Tafinlar plus Mekinist saw an overall response rate of 47% vs. 11% for those who received standard chemotherapy only.
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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
Pharma Times
JUNE 6, 2022
Enhertu reduced the risk of disease progression or death compared to chemotherapy in certain patients with metastatic breast cancer
BioSpace
JUNE 6, 2022
Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.
pharmaphorum
JUNE 6, 2022
Bristol-Myers Squibb’s all-cash offer for Turning Point Therapeutics – which values the biotech at $4.1 billion – bolsters its position in precision oncology and gives it a lead asset that could challenge cancer medicines from Roche and Pfizer. The $76-per-share offer revolves around repotrectinib (TPX-0005), a tyrosine kinase inhibitor (TKI) targeting ROS1 and NTRK in clinical testing for ROS1-positive, advanced non-small-cell lung cancer (NSCLC) as well as other solid tumours.
Drug Channels
JUNE 6, 2022
Time for an update to the Drug Channels Institute (DCI) annual analysis of pharmacist salaries and employment. The retail pharmacy shakeout affected 2021 pharmacist employment. We found that retail pharmacies and drugstores employed fewer pharmacists, while hospitals and outpatient centers continued to add positions. As a result, the share of pharmacists who work in non-retail practice settings reached a new high.
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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.
BioSpace
JUNE 6, 2022
The Phase I mechanism of action study, showing that Lilly's injectable Mounjaro (tirzepatide) induces greater weight loss than placebo and Novo Nordisk’s semaglutide in adults with type 2 diabetes.
Pharma Times
JUNE 6, 2022
New facility opens on the Cambridge Research Park offering pharmaceutical development services
BioSpace
JUNE 6, 2022
CEL-SCI Corporation, Jazz Pharmaceuticals, CARsgen and Ascentage Pharma presented clinical trial data at the American Society of Clinical Oncology 2022 Annual Meeting.
Outsourcing Pharma
JUNE 6, 2022
Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.
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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.
BioSpace
JUNE 6, 2022
Aslan partners with Johns Hopkins and Duke, Editas joins forces with Immatics, Yumanity (soon to be Kineta, Inc.) teams with Janssen, Serotiny & Janssen Biotech and Ginkgo and Novo Nordisk.
pharmaphorum
JUNE 6, 2022
Johnson & Johnson and Pfizer both highlighted new data with BCMA-targeting bispecific antibodies in patients with relapsed or refractory multiple myeloma (RRMM) at ASCO, previewing a future rivalry if they get regulatory approval. J&J’s Janssen pharma division gave an update on its MajesTEC-1 study of teclistamab , its already-filed BCMAxCD3 bispecific, in RRMM patients who had been treated with at least three prior lines of therapy with a median follow-up of 14 months.
BioSpace
JUNE 6, 2022
Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting a potential of more than 80 new regulatory approvals in oncology through 2028.
pharmaphorum
JUNE 6, 2022
Eisai’s first-ever attempt at developing an antibody-drug conjugate for cancer was rewarded with a $3.1 billion licensing deal from Bristol-Myers Squibb, and new data reported at ASCO has given a glimpse into its potential. Farletuzumab ecteribulin – also known as MORAb-202 – is being developed to treat tumours that overexpress folate receptor alpha (FR?
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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.
BioSpace
JUNE 6, 2022
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Outsourcing Pharma
JUNE 6, 2022
Coming back to the real world June 13-16, the industry event will offer face-to-face learning, networking opportunities, and fun, star-studded opportunities.
BioSpace
JUNE 6, 2022
Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.
Advarra
JUNE 6, 2022
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. Q: How do you promote a quality culture when senior management has a lack of knowledge of quality management systems (QMS) and is more interested in deliverables rather than quality? . A: That is a tough one. First, congratulations on realizing such a mindset may exist.
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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
JUNE 6, 2022
Code Bio, a biotechnology company leading the way in targeted non-viral delivery of generic medicines, closed a $75 million Series A financing round on Tuesday.
Intouch Solutions
JUNE 6, 2022
What do HGTV, hospice and palliative care, and Rx marketing all have in common? Well, me, for starters… but there’s so much more! Let me explain. My name is Nicole McCann-Davis, and I’m a Director of Strategic Planning. Throughout my career, I’ve had the privilege of supporting some really amazing organizations: television production for HGTV; communications for McDonald’s Corporation; communications and health equity and access lead for the multinational Accentcare (formerly known as Seas
BioSpace
JUNE 6, 2022
In the next eight years, more than 190 drugs will go off-patent for these companies. Of those, 69 are blockbuster drugs. ZS Associates' Maria Whitman provides analyses and tips.
The Pharma Data
JUNE 6, 2022
Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients. GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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