Pharmaceutical Technology
JANUARY 29, 2024
The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.
Bio Pharma Dive
JANUARY 29, 2024
The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.
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Pharmaceutical Technology
JANUARY 29, 2024
At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.
Bio Pharma Dive
JANUARY 29, 2024
An under-the-skin Opdivo shot produced similar results to an intravenous formulation in kidney cancer, giving Bristol Myers a chance at sustaining sales past a key patent expiration in 2028.
Pharmaceutical Technology
JANUARY 29, 2024
An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.
Rethinking Clinical Trials
JANUARY 29, 2024
The NIA IMPACT Collaboratory announced a new online certificate program designed to empower researchers at all levels in integrating health equity considerations into embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners. Program Overview This comprehensive training program, aligned with the IMPACT Collaboratory’s “Best Practices for Integrating Health Equity into ePCTs for Dementia Care” document, equips researchers with the knowled
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JANUARY 29, 2024
A successor medicine to Sarepta's Exondys 51 appeared better at boosting dystrophin protein production, but was associated with electrolyte imbalances.
Pharmaceutical Technology
JANUARY 29, 2024
The EMA CHMP has recommended marketing authorisation for Bristol Myers Squibb’s Abecma for multiple myeloma.
Fierce Pharma
JANUARY 29, 2024
The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.
Pharmaceutical Technology
JANUARY 29, 2024
The US FDA has granted priority review to the sBLA for ENHERTU, a treatment developed by Daiichi Sankyo and AstraZeneca for solid tumours.
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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
Antidote
JANUARY 29, 2024
For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Not only will patients be able to gain access to potential new treatments, but they will also be directly contributing to research that can save lives — something that Jamie Troil Goldfarb has experienced firsthand. Jamie received a diagnosis of stage IV melanoma in 2011, only 11 weeks after giving birth to her child.
Pharmaceutical Technology
JANUARY 29, 2024
The upcoming OCT West Coast 2024 conference will feature experts talking about emerging techologies, clinical trial operations for pharma and medical devices, and patient participation in studies.
Fierce Pharma
JANUARY 29, 2024
New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. | New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. WuXi Bio, for its part, says it's not affiliated with the military in China.
Pharmaceutical Technology
JANUARY 29, 2024
Celltrion USA has filed a biologics licence application (BLA) with the US FDA for its biosimilar candidate CT-P47.
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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
JANUARY 29, 2024
Creating a positive onboarding experience is crucial for engaging healthcare professionals (HCPs) in digital platforms and utilising data effectively. Discover why first impressions matter and how to get your onboarding process right for optimal digital engagement.
Pharmaceutical Technology
JANUARY 29, 2024
UK monarch King Charles was discharged from hospital today following treatment for an enlarged prostate or benign prostatic hyperplasia.
Pharmaceutical Commerce
JANUARY 29, 2024
In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.
Pharmaceutical Technology
JANUARY 29, 2024
Results from a Phase III trial indicated that adding MSD’s blockbuster drug boosted survival rates in advanced bladder cancer patients.
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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.
Outsourcing Pharma
JANUARY 29, 2024
Clinical-stage precision oncology company, Repare Therapeutics Inc., has received a $40 million milestone payment from Roche after dosing the first patient in a clinical trial.
Pharmaceutical Technology
JANUARY 29, 2024
Cristália has signed an agreement to license exclusive rights to market Formosa Pharmaceuticals’ APP13007 in Brazil.
pharmaphorum
JANUARY 29, 2024
Spanish drugmaker Grifols has hit back at hedge fund Gotham City Research, which claimed it had fraudulently manipulated its financial reporting, with a lawsuit filed in New York. The complaint has been brought against Gotham City and co-founders Daniel Yu and Cyrus de Weck, along with other defendants, and accuses them of being “predatory short sellers…who illicitly profit from their rigged short-and-distort schemes.
XTalks
JANUARY 29, 2024
Healthcare consulting is an increasingly dynamic and evolving field, offering extensive opportunities for those eager to significantly impact the healthcare industry. Read on to learn more about healthcare consulting jobs, covering the role specifics, necessary education, experience requirements and the career’s potential rewards. Healthcare consultants are pivotal in shaping healthcare delivery and policies.
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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.
BioPharma Reporter
JANUARY 29, 2024
Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear.
pharmaphorum
JANUARY 29, 2024
Bristol-Myers Squibb is getting closer to offering a subcutaneous version of its cancer immunotherapy Opdivo to patients after it matched the current intravenous formulation in a head-to-head trial in kidney cancer.
Fierce Pharma
JANUARY 29, 2024
Grifols has filed a lawsuit against Gotham City that accuses the hedge fund of manipulating "the value of Grifols’ stock for their own monetary gain.
pharmaphorum
JANUARY 29, 2024
GSK has claimed EU approval of Omjjara for the treatment of splenomegaly or symptoms in adult myelofibrosis patients with moderate-to-severe anaemia
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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.
Outsourcing Pharma
JANUARY 29, 2024
The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.
pharmaphorum
JANUARY 29, 2024
MSD’s Keytruda is the first cancer immunotherapy to improve survival when used as adjuvant therapy in renal cell carcinoma (RCC).
Pharma Times
JANUARY 29, 2024
A total of 103,277 general and acute beds are now available to NHS patients
pharmaphorum
JANUARY 29, 2024
AstraZeneca and Daiichi Sankyo’s Enhertu could become the first therapy approved by the FDA for use in any HER2-positive cancer, regardless of its location in the body. The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.
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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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