Bio Pharma Dive
JANUARY 26, 2024
The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.
Pharmaceutical Technology
JANUARY 26, 2024
CAR-T cell therapies can provide durable cancer remission, however, a recent FDA investigation into reports of secondary T-cell malignancies has increased scrutiny of their risk profiles.
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Bio Pharma Dive
JANUARY 26, 2024
The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.
Pharmaceutical Technology
JANUARY 26, 2024
Atossa Therapeutics estimates a Q3 Phase II readout for Z-endoxifen, as it plans a Phase III preventative breast cancer trial.
Fierce Pharma
JANUARY 26, 2024
Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives.
Pharmaceutical Technology
JANUARY 26, 2024
Type-2 diabetes patients continue to be impacted by GLP-1 RA drug shortages in the UK with an NHS alert issuing guidelines on drug substitutions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 26, 2024
Renalys plans to start a registrational trial for sparsentan as a treatment for IgA nephropathy in Japan in Q2 2024.
XTalks
JANUARY 26, 2024
World Cancer Day 2024 is a global initiative that emphasizes the importance of heightened awareness about cancer. This day is observed annually on February 4th since its inception by the Union for International Cancer Control (UICC) in 2000. World Cancer Day is dedicated to encouraging early detection, prevention and treatment while also advocating for improved access to healthcare services for those affected by cancer.
Pharmaceutical Technology
JANUARY 26, 2024
Regeneron and Sanofi’s blockbuster anti-inflammatory drug generated global sales of $8.68bn in 2022.
Pharmaceutical Commerce
JANUARY 26, 2024
Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.
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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
JANUARY 26, 2024
Using digital twins, healthcare professionals can analyse real-time individual health data using a virtual representation.
Fierce Pharma
JANUARY 26, 2024
With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. | With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP).
Drug Discovery World
JANUARY 26, 2024
Researchers from Tokyo University of Science (TUS) have found a simple, low-cost way to optimise the production of monoclonal antibodies (mAbs) and reduce manufacturing costs. Dr Kyohei Higashi, Associate Professor at TUS, along with a team of researchers, conducted a study to explore the effects of polyamines on N-linked glycan profiles of mAbs in CHO DP-12 cells. “Because the carbohydrate structure of mAbs changes depending on the state of the cells, we were interested in investigating t
Fierce Pharma
JANUARY 26, 2024
In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. | In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. Now, a little more than a year later, AbbVie is getting in on the action by starting a major production expansion in the Garden City.
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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 Commerce
JANUARY 26, 2024
A non-randomized control trial investigates whether older adults with multiple chronic conditions can benefit by receiving more specialized services.
Fierce Pharma
JANUARY 26, 2024
The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit against | The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit.
Pharma Times
JANUARY 26, 2024
In 2022, over 39,000 people in England died prematurely of cardiovascular conditions
Fierce Pharma
JANUARY 26, 2024
At Sanofi and Regeneron, it’s all about the kids—at least with respect to their recent advancements of anti-inflammatory powerhouse Dupixent. | The FDA has signed off on Sanofi and Regeneron's Dupixent to treat children between the ages of 1 and 11 who weigh at least 33 pounds with eosinophilic esophagitis. Dupixent becomes the first treatment in the U.S. for children in this age group with the 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.
Pharma Times
JANUARY 26, 2024
HPV is a common group of viruses which can sometimes lead to cancer
Fierce Pharma
JANUARY 26, 2024
Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will appeal the guidance.
pharmaphorum
JANUARY 26, 2024
AbbVie has broken ground on a new $223 million expansion of its biologics manufacturing facility in Singapore, creating around 100 new jobs
XTalks
JANUARY 26, 2024
The US Food and Drug Administration (FDA) has added a boxed warning to the safety information of Amgen’s osteoporosis drug Prolia (denosumab) for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). Hypocalcemia refers to an abnormally low level of calcium in the blood. The FDA said that CKD patients on dialysis or who have mineral and bone disorders (CKD-MBD) are at the greatest risk of the condition.
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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.
pharmaphorum
JANUARY 26, 2024
Eli Lilly is weeks away from launching Mounjaro in the UK, after getting approval from the MHRA for a multi-dose injector version for diabetes and obesity
XTalks
JANUARY 26, 2024
In the competitive ingredients market, North Carolina’s Elo Life Systems has quickly become a leader in sustainable food solutions. Just a year after raising $24.5 million in Series A funding , the company has earned another $20.5 million in a Series A2 funding round jointly led by DCVC Bio and Novo Holdings. Founded in 2021, the company has already made a mark with its focus on plant-based sweeteners and crop protection.
pharmaphorum
JANUARY 26, 2024
Report on UK biotech sector by Tony Blair and William Hague calls for an NHS trust to be set up to oversee and sell patient data
Pharmaceutical Commerce
JANUARY 26, 2024
As providers and healthcare professionals recognize the potential of long-acting injectables to fight the opioid epidemic, many are actively transitioning from oral options to injectables.
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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
JANUARY 26, 2024
ArriVent BioPharma completes the second biotech IPO of 2024, raising $175m that will help advance its late-stage lung cancer drug furmonertinib
Drug Discovery World
JANUARY 26, 2024
Strand Therapeutics has announced an 18% cut to its workforce, just days after the US Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application to initiate a first-in-human trial of STX-001 for solid tumours. On LinkedIn the company said: “This week, Strand has made the difficult strategic decision to reduce our workforce by approximately 18% in order to continue investing into our breakthrough discovery programmes and efficiently progress our first clinical trial
pharmaphorum
JANUARY 26, 2024
From pandemic spotlight to global progress: Navigating technology transfer for healthcare innovation Mike.
Drug Discovery World
JANUARY 26, 2024
News round-up for 22-26 January by DDW Digital Content Editor Diana Spencer. In the same week that it was revealed that breast cancer was the most studied disease area in 2023 for the third year running, there were a number of promising developments in the treatment of colorectal, pancreatic and lung cancer and leukaemia. The top stories: Breast cancer most researched disease area for third year running Breast cancer was the most studied disease in 2023 for the third consecutive year, followed b
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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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