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 15, 2022

Acrivon is the 20th biotech company to go public this year, roughly a fifth of last year’s total at this time, and had to sell more shares at a lower price to complete the deal.

Drugs 334

Drugs 334

STAT News

NOVEMBER 18, 2022

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

145

145

NPR Health - Shots

NOVEMBER 16, 2022

NPR spoke with 26 people who were involved with more than 200 executions across the country. Most said their health suffered and they had little support to help them cope with their unusual jobs.

145

145

Advertisement

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 17, 2022

The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update. This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike.

Hormones 257

Hormones Compliance Research 257

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.

Development 359

Development Drugs 359

NPR Health - Shots

NOVEMBER 15, 2022

State law at the time prohibited abortion after around 6 weeks. Legal experts say this kind of law leaves doctors uncertain of what's legal and can put patients in dangerous situations.

Doctors 145

Doctors Doctor 145

Pharmaceutical Technology

NOVEMBER 16, 2022

ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic.

Development 246

Development Gene Therapy Engineer Gene Editing 246

Bio Pharma Dive

NOVEMBER 16, 2022

Tricida, Harpoon, Freeline and three other small drug developers have this week announced plans to cut staff or to reprioritize their drug development.

Research 346

Research Development Drugs 346

STAT News

NOVEMBER 16, 2022

BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone , a key drug used to treat opioid use disorder. American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday.

Research 144

Research Doctors Doctor Drugs 144

Advertisement

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

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.

145

145

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 15, 2022

Backed by the same investors and team as an immunotherapy biotech Roche bought in September, Bonum Therapeutics plans to develop “conditionally” active cancer medicines.

Medicine 311

Medicine Development 311

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

Advertisement

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

NPR Health - Shots

NOVEMBER 17, 2022

Some credit cards advertised by hospitals lure in patients with rosy promises of convenient, low-interest payments on big bills. But interest rates soar if you can't quickly pay off the loan.

143

143

STAT News

NOVEMBER 17, 2022

Editas Medicine, one of the small handful of original CRISPR companies, announced Thursday it is halting development on its first clinical program after data showed only a small subset of patients were responding. Edit-101, an experimental CRISPR-based treatment for a rare eye disease called CEP290-meditated LCA10, led to “clinically meaningful” improvements in sight in only three out of 14 patients treated in the company’s Phase I study.

Development 134

Development Medicine 134

Bio Pharma Dive

NOVEMBER 18, 2022

Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen.

FDA Approval 318

FDA Approval Drugs 318

Medical Xpress

NOVEMBER 15, 2022

The business magnate and new owner of Twitter Elon Musk revealed a while ago that he is autistic. Musk, the wealthiest person in the world, is autistic. Musk, a fellow of the prestigious Royal Society and Time's 2021 Person of the Year, is autistic. One of the most famous people on Earth is autistic. Perhaps it is worth letting that sink in?

122

122

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

NPR Health - Shots

NOVEMBER 12, 2022

The group Swayam Shikshan Prayog, which will be recognized today at the U.N. COP27 summit, focuses on the restoration of livelihoods, especially for women, amid the negative impacts of climate change.

128

128

STAT News

NOVEMBER 18, 2022

BOSTON — As Pfizer prepares to hike the price of its Covid-19 vaccines, the company’s CEO, Albert Bourla, maintained at a conference this week that the jabs will continue to be “free for all Americans” because insurers are required to pay the extra cost. “Americans will see no difference,” said Bourla, speaking Wednesday at the STAT Summit.

Vaccination 130

Vaccination Vaccine 130

Bio Pharma Dive

NOVEMBER 17, 2022

While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish.

Gene Editing 302

Gene Editing Medicine Gene Development 302

pharmaphorum

NOVEMBER 15, 2022

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

Marketing 125

Marketing 125

Advertisement

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 16, 2022

New research points to a surprising way to stop spillovers of Hendra virus, which is harbored by bats. It's not often that it jumps to horses, then humans, but when it does, the result are brutal.

Research 121

Research 121

STAT News

NOVEMBER 18, 2022

Biosplice’s bid to transform the treatment of everything from arthritis to cancer ran into a snag this week, with the San Diego biotech announcing that its experimental osteoarthritis drug failed to benefit patients in a pair of Phase 3 clinical trials. The results, presented at the American College of Rheumatology conference in Philadelphia, show that the small-molecule drug lorecivivint failed to significantly soothe the pain of osteoarthritis patients.

Trials 128

Trials Clinical Trials Clinical Trials Drugs 128

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 301

Immune Response Vaccination Vaccine 301

pharmaphorum

NOVEMBER 16, 2022

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.

Sales 123

Sales Gene Therapy Allergies Medicine 123

Advertisement

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

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.

121

121

STAT News

NOVEMBER 15, 2022

BOSTON — The executives behind Altos Labs would really, really like people to stop saying they’re trying to reverse aging. They have a couple things going against them on this count. For one, the first article about the biotech and its $3 billion stash talked about Silicon Valley billionaires “ living forever.” And then there’s their most prominent scientist’s tendency to talk openly about people living to 130.

Scientist 128

Scientist 128

Bio Pharma Dive

NOVEMBER 17, 2022

The new candidate is meant to provide broader immunity over a longer period of time and is part of the companies’ strategy to stay ahead of a shifting coronavirus threat.

Vaccination 291

Vaccination Vaccine 291

Medical Xpress

NOVEMBER 17, 2022

BRCA1 (BReast CAncer Gene 1), a key gene that becomes faulty in some instances, leading to breast and ovarian cancer, plays an important role in the body's DNA repair mechanisms. BRCA1, once mutated, can cause cancer to develop. According to the Center for Familial Breast and Ovarian Cancer at the Vienna General Hospital, it is believed that if the BRCA1 or BRCA2 gene is mutated, the likelihood of developing breast and ovarian cancer increases to 85% and 53% respectively.

DNA 119

DNA Production Gene Development 119

Advertisement

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials