Bio Pharma Dive
AUGUST 11, 2023
Filed in Maryland district court, the lawsuit claims the biotech unjustly profited from using HeLa cells to develop AAV vectors for its gene therapy products.
Pharmaceutical Technology
AUGUST 11, 2023
The latest tag adds to three fast track designations for Reqorsa, with the company initiating a Phase I/II trial in Q4 2023.
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Bio Pharma Dive
AUGUST 11, 2023
ALX Oncology’s decision to end studies in leukemia and myelodysplastic syndrome follows a similar setback from Gilead and casts further doubt on drugs known as CD47 inhibitors.
Pharmaceutical Technology
AUGUST 11, 2023
Following the business expansion in 2022, Clinigen announced the divestment of four of its cancer therapies.
Bio Pharma Dive
AUGUST 11, 2023
In Europe, however, the biotech is appealing a negative decision from regulators that has for now blocked its path to market there.
Pharmaceutical Technology
AUGUST 11, 2023
Absci, in collaboration with Caltech, has received a grant from the Bill & Melinda Gates Foundation to advance HIV therapeutic vaccine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 11, 2023
City of Hope researchers are developing a chimeric antigen receptor (CAR) T cell therapy for the treatment of recurrent ovarian cancer.
XTalks
AUGUST 11, 2023
Sabra hummus recently unveiled three new flavors that unite America’s favorite velvety and irresistible hummus with some of the nation’s boldest and most beloved flavor brands. These innovative hummus varieties are infused with a combination of heat, smoke, spice and Texas-style barbeque. The new flavors include: Sabra Buffalo Hummus made with Frank’s RedHot: Sabra collaborated with the renowned Frank’s RedHot to create a Buffalo Hummus, a blend of creamy indulgence and s
Pharmaceutical Technology
AUGUST 11, 2023
Oxurion has received €1m ($1.09m) in funding from Atlas as part of a subscription agreement with Atlas totalling up to €20.8m ($25m).
XTalks
AUGUST 11, 2023
Healthcare facilities management is a comprehensive approach to overseeing the various facets of healthcare facilities, spanning their development, maintenance, security and operations. The core objective is to create a secure, reliable environment for patient care within the healthcare sector. This is achieved by synergizing facilities, assets and personnel to uphold the highest patient care standards.
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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 11, 2023
The US Food and Drug Administration (FDA) has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for CRESEMBA.
Fierce Pharma
AUGUST 11, 2023
It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy. | The Supreme Court has halted Purdue Pharma’s $6-billion bankruptcy settlement, which granted the company’s former owners—the Sackler family—immunity from civil suits related to the opioid crisis.
Pharmaceutical Technology
AUGUST 11, 2023
In June, Sutro received a $140m payment from Blackstone Life Sciences as part of the Vaxcyte product licensing agreement.
Fierce Pharma
AUGUST 11, 2023
Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio continues to wow Wall Street. | Amylyx’s amyotrophic lateral sclerosis drug Relyvrio continues to wow Wall Street. The drug brought in $98.2 million revenue in the second quarter, handily beating analysts’ consensus estimates of below $92 million.
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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 11, 2023
Antengene has signed a collaboration agreement with Hansoh Pharma to commercialise XPOVIO (selinexor) in mainland China.
Fierce Pharma
AUGUST 11, 2023
Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical syste | Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical system.
Pharmaceutical Technology
AUGUST 11, 2023
TriSalus is breaking into cancer therapeutics research with its TLR agonist SD-101 for treating solid tumours.
Pharma Times
AUGUST 11, 2023
Highly selective inhibitor therapy treats patients with chronic spontaneous urticaria - News - PharmaTimes
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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 11, 2023
Babylon, Galera and more are cutting staff, serving as a reminder that failure is easy in the medical world.
BioSpace
AUGUST 11, 2023
After reaching a settlement with Thermo Fisher earlier this month, the family of Henrietta Lacks is now suing Ultragenyx for its “unjust enrichment” using their matriarch’s immortal cell line.
Pharma Times
AUGUST 11, 2023
Data supports further exploration of candidate as a rapid-acting anti-depressant for home use - News - PharmaTimes
Fierce Pharma
AUGUST 11, 2023
Bristol Myers Squibb has laid off more than 100 employees amid a reconfiguration of expenses that follows disappointing earnings results. | Bristol Myers Squibb has laid off more than 100 employees amid a reconfiguration of expenses that follows disappointing earnings results.
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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
AUGUST 11, 2023
The Supreme Court of the United States has granted the Department of Justice’s motion for a stay regarding Purdue’s bankruptcy case and is set to assess the legality of the settlement in December.
Fierce Pharma
AUGUST 11, 2023
Since Pfizer’s smoking cessation drug Chantix was recalled in 2021, Endo's subsidiary Par Pharmaceuticals has been the only one to market the product. | Endo alleges that Zydus Pharmaceuticals infringed upon its Chantix patent, asserting that there is no alternative method for producing the drug without the impurities that led to the removal of Pfizer's original product from the market.
BioSpace
AUGUST 11, 2023
The clinical-stage company joins several others in the anti-CD47 space which have dropped studies amid poor results, including Gilead Sciences’ decision late last month to stop a Phase III trial.
Pharmaceutical Commerce
AUGUST 11, 2023
MIT’s Barbara Wixom, PhD, outlines the importance of data-powered research in producing financial success.
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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 11, 2023
Ahead of an FDA decision in the third quarter, Regeneron is touting promising durability data from the Phase III PULSAR trial for higher-dose Eylea in patients with wet age-related macular degeneration.
Drug Channels
AUGUST 11, 2023
Today’s guest post comes from Rebecca Cotton, Executive Director of Strategy & Product Innovation at Cardinal Health ™ Sonexus ™ Access and Patient Support Rebecca discusses the essential features biopharmaceutical manufacturers should seek in a digital hub that will help patients get their therapies faster. She argues that the most effective hub balances automation with the still-relevant value of human interactions.
BioSpace
AUGUST 11, 2023
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
pharmaphorum
AUGUST 11, 2023
Strong solutions for increasing dermatology research diversity: Trust me, I’ve got skin in the game Mike.
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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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