Bio Pharma Dive
AUGUST 25, 2022
In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.
Pharmaceutical Technology
AUGUST 25, 2022
The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).
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Bio Pharma Dive
AUGUST 25, 2022
The pharma contributed to an $84 million round for the new cancer drugmaker, which attracted Novartis and Bristol Myers Squibb in an earlier fundraise.
World of DTC Marketing
AUGUST 25, 2022
Research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information on the Internet. Additionally, 49% have accessed a website that provides information about a specific medical condition or problem. Many people get health information from the Internet but are left on their own to determine if it’s credible.
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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
Bio Pharma Dive
AUGUST 25, 2022
After several years in stealth, 3T Biosciences is launching publicly with plans to develop newer types of T cell receptor-based treatments.
Pharmaceutical Technology
AUGUST 25, 2022
Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. The centre, which will expand the company’s operations in Seattle, US, will aid in the R&D and manufacturing at scale its gene-modified regulatory T cell (T reg ) therapy pipeline for autoimmune and inflammatory ailments.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
AUGUST 25, 2022
So sweat doesn't really smell bad at all. But when bacteria eat the sweat — nostrils, look out! Only it turns out that these sweat-eating critters are responsible for a big health benefit.
Bio Pharma Dive
AUGUST 25, 2022
The biotech signed a 30-year deal with the University of Pittsburgh to establish a gene and cell therapy manufacturing hub that’s being built with a $100 million grant.
STAT News
AUGUST 25, 2022
Casinos dazzle you with flashing lights, high-stakes tables, and the chance to win millions of dollars. The house always wins, but casinos still trick people into thinking they will make money. Substitute Medicare for casinos and you can see what physicians who take risks with the country’s largest health payer are up against. I’m an orthopedic surgeon, so I’ll focus here on this specialty.
Bio Pharma Dive
AUGUST 25, 2022
On a conference call, BioMarin executives revealed the anticipated price for Roctavian and the company's initial launch plans, which include pay-for-performance deals customized to different markets.
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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
NPR Health - Shots
AUGUST 25, 2022
Three sisters set out to learn why many of the people in their family develop Alzheimer's disease in middle age — and what they can do about it.
STAT News
AUGUST 25, 2022
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pharmaphorum
AUGUST 25, 2022
Amazon’s ambitious plan to disrupt the healthcare category seems to have had a course correction after the online retail giant announced it plans to shut down its telehealth service Amazon Care. It’s a dramatic change in direction, coming just a few months after Amazon was trumpeting its intention to make the three-year-old telehealth service available to employers nationwide in the US.
STAT News
AUGUST 25, 2022
BOSTON — When a routine cancer screening came back showing an elevated PSA reading, George Brickhouse knew he should take it seriously. His father had been treated for prostate cancer and his brother had dealt with a scare. But the urologist he went to see started ordering tests without fully explaining why. And when he couldn’t get through to a live person to schedule an MRI, he gave up trying to find out whether he had cancer.
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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
AUGUST 25, 2022
For most of my adult life, I had been the typical American fat guy, gaining a pound or two a year and thinking little of it. That was until my doctors stunned me with the news that I had cirrhosis caused by non-alcoholic steatohepatitis, or NASH, a severe form of fatty liver disease that often has few or no symptoms until very late stages. I had never heard of NASH, and I was even more shocked when I started searching online and discovered the prevalence of the disease and the tragic reality tha
STAT News
AUGUST 25, 2022
A vaccine Pfizer is developing protected older adults against the respiratory syncytial virus, or RSV, which is a common cause of hospitalization and death in the U.S., the company said Thursday. The experimental vaccine, known as RSVpreF, is considered a key product in Pfizer’s pipeline of experimental drugs. Right now drug companies are close to launching several different products against RSV, focused on protecting both older adults and infants.
pharmaphorum
AUGUST 25, 2022
Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.
STAT News
AUGUST 25, 2022
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that struck down the constitutional right to abortion guaranteed by Roe v. Wade in 1973 is also a huge setback for genetic counseling and the people who need it. In 2013, when anti-abortion activists were still forced to maneuver around Roe v. Wade, North Dakota passed a law banning abortions that are motivated by diagnosis of a “genetic abnormality or potential for a genetic abnormality.
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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
AUGUST 25, 2022
Teclistamab is the first bispecific antibody worldwide to be approved for patients with relapsed and refractory multiple myeloma
STAT News
AUGUST 25, 2022
Despite stubbornly high maternal mortality in the United States, pregnancy is still woefully under-researched. But thanks to the Covid-19 pandemic, technology that makes it easier to study pregnancy is starting to catch up. During the public health emergency, federal agencies, health systems, and medical data companies were motivated to open up their records and create privacy-preserving methods to help hospitals share sensitive patient records for research.
Pharma Times
AUGUST 25, 2022
In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over
STAT News
AUGUST 25, 2022
The bidding war over Signify Health — a health technology business that could fetch multibillion-dollar offers from Amazon, CVS, and UnitedHealth Group — is not about its dazzling software or a blockbuster AI algorithm. The crush of corporate interest, experts said, stems from something much bigger: the opportunity to move medical services back into the home.
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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.
XTalks
AUGUST 25, 2022
BetterBrand, the startup behind the low-carb, high-protein Better Bagel , announced its global partnership with Whole Foods Market. One year after its online debut, BetterBrand’s Better Bagel hit the frozen shelves of over 500 Whole Foods Market locations, bringing its “Grain-Changing” technology to retail. . “The Better Bagel transforms the carb heavy bagel into the net carb equivalent of two slices of banana, while boasting 25g+ of plant-based protein, no added sugar and a Non-GMO Certified, c
STAT News
AUGUST 25, 2022
Centene, one of the largest health insurers in the U.S., agreed to pay $33 million to settle allegations that its pharmacy benefits subsidiary overcharged the Washington state Medicaid program, the latest in a string of such settlements. The deal came after a whistleblower provided information three years ago that Centene failed to disclose accurate pharmacy benefits and services as part of its contract with the state Medicaid program.
pharmaphorum
AUGUST 25, 2022
Indian drugmaker Koye Pharma has partnered with Sonde Health to develop its vocal biomarker technology – which aims to diagnose diseases from voice patterns – for use in chronic obstructive pulmonary disease (COPD). Mumbai-based Koye is the first pharma company to partner with Sonde Health on the technology, which is also being used in a standalone app to monitor people’s mental health and wellbeing.
STAT News
AUGUST 25, 2022
For as long as Daniel McKizzie can remember, church has been part of his life. McKizzie — Reverend McKizzie to his congregation — is the pastor and founder of New Creation Baptist Church in Minneapolis, Minn. A new study suggests that church may be part of his long-term health as well. Cardiovascular disease is the leading cause of death among all Americans, and even more so among Black Americans, who are 30% more likely than any other group to die from cardiovascular disease.
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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.
NPR Health - Shots
AUGUST 25, 2022
NPR's Ari Shapiro talks with Mary Ziegler, professor of law at UC Davis, to discuss the impact of the trigger laws banning abortion in Tennessee, Idaho and Texas.
Outsourcing Pharma
AUGUST 25, 2022
The pharmaceutical company and the artificial intelligence pathology specialist will focus on translational research in oncology, fibrosis, and immunology.
BioPharma Reporter
AUGUST 25, 2022
The Swiss pharma giant wants to turn its biosimilar and generics division into a standalone company.
pharmaphorum
AUGUST 25, 2022
Verily’s Amy Abernethy and DiMe’s Jennifer Goldsack return for a second conversation on data and healthcare, this one focusing on specific use cases and examples. In part two, Jenn and Amy talk a little more about the work they do and list out some of the most promising use cases for data-driven approaches in healthcare including clinical research and chronic care.
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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.
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