Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

Antibody 362

Antibody Gene Therapy Manufacturing Trials 362

Bio Pharma Dive

NOVEMBER 14, 2022

The deal, which could carry a total value of roughly $145 million, is in large part focused on a nasal formulation of the opioid overdose drug nalmefene.

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Development Drugs 359

Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Bio Pharma Dive

NOVEMBER 14, 2022

New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.

Immune Response 305

Immune Response Vaccination Vaccine 305

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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

Clinical Research

Pharmaceutical Technology

NOVEMBER 14, 2022

BioNTech’s Singapore affiliate BioNTech Pharmaceuticals Asia Pacific has signed an agreement with Novartis Singapore Pharmaceutical Manufacturing to acquire a GMP-certified manufacturing site in the country. . The latest development is part of the expansion plans of BioNTech to boost its international footprint in Asia. . Backed by the Singapore Economic Development Board (EDB), the site will become completely operational late next year.

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Manufacturing Vaccination Vaccine Production 162

Bio Pharma Dive

NOVEMBER 14, 2022

Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials.

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Trials Drugs 230

Bio Pharma Dive

NOVEMBER 14, 2022

Hunter Allen realized he loved the responsibility of caring for others. At Regis, he learned how to hone his passion and create healthy communities.

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Worldwide Clinical Trials

NOVEMBER 14, 2022

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

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Trials Clinical Trials Clinical Trials Drugs 137

Bio Pharma Dive

NOVEMBER 14, 2022

Normalized lab data can help pharma companies promote their therapies to a targeted audience.

Pharma Companies 246

Pharma Companies 246

Pharmaceutical Technology

NOVEMBER 14, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Oncopeptides’ Pepaxti (melphalan flufenamide; melflufen) along with dexamethasone to treat multiple myeloma patients. Pepaxti plus dexamethasone is intended to treat adult patients who have received a minimum of three previous lines of treatment.

Marketing 130

Marketing Drugs Clinical Trials Clinical Trials 130

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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

Clinical Trials

Bio Pharma Dive

NOVEMBER 14, 2022

Learn about key factors and trends in RWE and why a data luminary is crucial to your success.

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246

NPR Health - Shots

NOVEMBER 14, 2022

The meat of the future may be cultured directly from animal cells without slaughtering livestock. It's not yet sold in the U.S., but NPR got a tour of a leading start-up and a taste of their chicken. (Image credit: Brian L.

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Bio Pharma Dive

NOVEMBER 14, 2022

The RNA drug developer is paying the richly-funded startup $80 million in a wide-ranging alliance that marks its first foray into DNA editing medicines.

Gene Editing 161

Gene Editing RNA DNA Gene 161

Medical Xpress

NOVEMBER 14, 2022

A new study published in Diabetologia finds that outdoor artificial light at night (LAN) is associated with impaired blood glucose control and an increased risk of diabetes, with more than 9 million cases of the disease in Chinese adults being attributed to LAN exposure. The study is by Dr. Yu Xu and colleagues at the Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Medicine 136

Medicine 136

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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.

Clinical Supply

NPR Health - Shots

NOVEMBER 14, 2022

Readers responded with moving stories of past journeys and crises — and keepsakes that remind them of their roots and tie them to their family. Here's a sampling of replies.

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STAT News

NOVEMBER 14, 2022

Mile Bluff Medical Center is a long way from Silicon Valley. The 40-bed hospital is situated in a central Wisconsin city of 4,400 people, where caregivers are about as likely to encounter a moose as a machine learning engineer. That is, until now.

Engineer 116

Engineer 116

pharmaphorum

NOVEMBER 14, 2022

Sanofi and Regeneron’s Dupixent is on track to become the first targeted drug in the EU to be approved for prurigo nodularis (PN), a rare and highly debilitating skin disease. The EMA’s human medicines committee (CHMP) has recommended IL-4 and IL-13 inhibitor Dupixent (dupilumab) to treat adults with moderate to severe PN, a disease which causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain.

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Sales Immune Response Drugs Medicine 114

STAT News

NOVEMBER 14, 2022

The brains of Black adults in the U.S. age more quickly than those of white and Hispanic adults, showing features linked to Alzheimer’s disease and other dementias as early as mid-life, according to a new study. The study , published Monday in JAMA Neurology, analyzed the MRI scans of nearly 1,500 participants from two racially and ethnically diverse cohorts.

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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.

Clinical Trials

Medical Xpress

NOVEMBER 14, 2022

A new study in mice from researchers at The University of Texas at Dallas suggests that a short-term exposure to a high-fat diet may be linked to pain sensations even in the absence of a prior injury or a pre-existing condition like obesity or diabetes.

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Research 105

STAT News

NOVEMBER 14, 2022

At first glance, it might appear that better access to so-called amyloid-PET scans could compensate for some of the racial inequities in Alzheimer’s disease , as Linda Goler Blount called for in a recent First Opinion essay. In theory, such scans should lead to more Black people — who are at higher risk of developing Alzheimer’s — being screened and having greater access to favorable treatment for their disease.

Development 111

Development Research 111

NPR Health - Shots

NOVEMBER 14, 2022

The iconic singer of "Killing Me Softly" has the condition also known as Lou Gehrig's disease, a representative has announced. For Roberta Flack, it is now "impossible to sing and not easy to speak.

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STAT News

NOVEMBER 14, 2022

Money has gushed into the biotech industry over the last couple of years, as the pandemic brought the industry onto center stage. At the same time, tech investors have rushed into the arena. Who has benefited the most?

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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.

Clinical Supply

pharmaphorum

NOVEMBER 14, 2022

Every fraction of a degree matters. COP27 is in full swing and world leaders are contending with the fact that we will likely not meet the Paris Agreement’s 1.5°C target. The reality is that we will need to focus on limiting a temperature rise wherever possible and that every fraction of a degree has a real and major consequence on our global environment.

Medicine 105

Medicine Regulation Production Clinical Trials 105

Medical Xpress

NOVEMBER 14, 2022

Regular physical activity can extend colorectal cancer patients' lives. In a first-ever study, scientists looked at the impact of exercise on the gut microbiome of cancer patients and reported a positive association. The gut microbiome is the largest portion of the body's collection of bacteria and other microbes that live in and on the body, according to the National Cancer Institute.

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Bacteria Scientist Research 104

STAT News

NOVEMBER 14, 2022

New data indicate Moderna’s Covid bivalent booster may be more effective against currently circulating Omicron variants of the virus than its original vaccine, the company said Monday. Like data released by Pfizer and BioNTech regarding their Covid vaccine , the new data involves lab measurements of antibodies and their ability to neutralize the SARS-CoV-2 virus, not data on how well the vaccines prevent cases of symptomatic illness or severe disease.

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Vaccination Vaccine Antibody 98

Medical Xpress

NOVEMBER 14, 2022

New study results from an international research team led by USC scientists have identified a signature pattern of white matter connectivity exclusive to the brains of autistic people distinct from that in the brains of people with developmental coordination disorder (DCD).

Scientist 98

Scientist Research 98

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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.

Clinical Trials

STAT News

NOVEMBER 14, 2022

When Barrett Rollins walked into the bathroom of his Beacon Hill home, he was stunned to find his wife lying on the uneven tile floor covered in blood. Rollins and his wife, Jane Weeks, were physicians and researchers at Dana-Farber Cancer Institute and lived steps from some of the world’s best hospitals. But Weeks didn’t want medical help.

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Research 98

Medical Xpress

NOVEMBER 14, 2022

Young people who believe they come from poorer backgrounds than their friends are more likely to have lower self-esteem and be victims of bullying than those who feel financially equal to the rest of their peer group, according to a new study from psychologists at the University of Cambridge.

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STAT News

NOVEMBER 14, 2022

Any other Monday morning, Josh Mesfin would have been in the lab, performing surgery on rats and devising new ways to help them heal from heart attacks — with the hope of one day using those same tools to help people. But the fourth-year UC San Diego bioengineering graduate student spent the day chanting and marching alongside fellow academic workers who launched a strike at 10 University of California campuses on Monday, decrying low wages that Mesfin says make instant ramen a dietary st

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Scientist 98

Medical Xpress

NOVEMBER 14, 2022

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot get vaccinated or in the event that dangerous new strains of the virus arise that could bypass vaccine protection.

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Vaccination Vaccine Scientist Drugs 98

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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.

Clinical Trials