Tue.Jan 31, 2023

article thumbnail

A startup launches with plans to open up a gene and cell therapy bottleneck

Bio Pharma Dive

The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.

Gene 294
article thumbnail

Our Body Temps Have Been Dropping For 160 Years. Gut Microbes May Be Playing a Role

AuroBlog - Aurous Healthcare Clinical Trials blog

The average temperature of the human body has been steadily declining since the middle of the 19th century, and scientists aren’t sure why. A new study suggests one key factor that might play a role in this: gut microbes.

Scientist 214
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Humira biosimilars arrive in the US, as Amgen launches first copycat to AbbVie’s blockbuster drug

Bio Pharma Dive

The world’s best-selling drug will face pricing pressure as rivals try to steal share away from AbbVie’s $20 billion-a-year flagship product in the U.S.

Drugs 269
article thumbnail

EMA’s CHMP recommends approval of Sandoz’s Hyrimoz biosimilar

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Sandoz’s citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab) biosimilar. The company is seeking regulatory approval of Hyrimoz for several indications, including ulcerative colitis, plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and uveitis, covered by the reference medicine.

Antibody 162
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

UniQure nabs another gene therapy for ALS

Bio Pharma Dive

For $10 million up front, UniQure has licensed rights to its second experimental treatment for the condition, a medicine from startup Apic Bio that should enter human testing later this year.

article thumbnail

NCC-MvPI identifies 119 new MDAEM centres in various states to report medical device adverse events

AuroBlog - Aurous Healthcare Clinical Trials blog

The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the national co-coordinating centre (NCC) for the Materiovigilance Programme of India (MvPI) has identified 119 new Medical Device Adverse Event Monitoring (MDAEM) centres in various states to report medical device adverse events.

More Trending

article thumbnail

Can You Sue Your Doctor for Blindness Caused by Elmiron®?

Pharma Mirror

The Janssen Pharmaceuticals-produced medication Elmiron® is used to treat interstitial cystitis. Elmiron may be connected to eye damage that results in vision loss or other negative effects like blurry vision, according to some studies. A multidistrict litigation has been started by more than 1,700 people who have used Elmiron for a prolonged period of time and have developed eyesight impairments in an effort to recover damages.

Doctors 130
article thumbnail

January 31, 2023: New Article Suggests Moving From Idealism to Realism With Data Sharing

Rethinking Clinical Trials

From left to right: Keith Marsolo, Kevin Weinfurt, Karen Staman, and Bradley Hammill In an article published today in the Annals of Internal Medicine , leaders of the NIH Pragmatic Trials Collaboratory suggest that data sharing is not rising to its potential, and that more guidance is needed to prevent data sharing from becoming a “box-checking exercise.” “NIH should consider guidance to help investigators and NIH institutional centers understand what needs to be shared, for what reason, a

article thumbnail

Daewoong and CSP sign licence deal for IPF therapy in Greater China region

Pharmaceutical Technology

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF). Under the deal, CSP will have exclusive rights for the development and marketing of Bersiporocin to treat IPF as well as other respiratory indications in the region, including mainland China, Macau, Hong Kong, and Taiwan.

article thumbnail

Court rules for drugmakers in 340B fight over contract pharmacies

Bio Pharma Dive

The decision is a win for Sanofi, Novo Nordisk and AstraZeneca. The drugmakers sued HHS after regulators ordered them to stop restricting sales of 340B drugs to contract pharmacies.

Pharmacy 130
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said.

Drugs 130
article thumbnail

MRI scans reveal disparate impact of poverty and other ‘toxic stress’ on brains of Black children

STAT News

Stressful experiences during early childhood — particularly economic strife — appear to act as a toxic stressor that can alter regions of the brain tied to the processing of stress and trauma, according to a new study published Wednesday. The researchers found that Black children were impacted more than white children, largely because of the higher amounts of poverty and adversity they face.

Research 131
article thumbnail

Scant obesity training in medical school leaves docs ill-prepared to help patients

NPR Health - Shots

Most doctors get little training in the science of obesity or how to counsel people with the disease. As a result, many patients experience stigma in the exam room.

Doctors 133
article thumbnail

Assessing Fitness-for-Use of Clinical Data for PCTs – Training Resources Page

Rethinking Clinical Trials

Assessing Fitness-for-Use of Clinical Data for PCTs Handout A handout describing data quality checks and recommendations for assessments The post Assessing Fitness-for-Use of Clinical Data for PCTs – Training Resources Page appeared first on Rethinking Clinical Trials.

article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

AbbVie's blockbuster drug Humira finally loses its 20-year, $200 billion monopoly

NPR Health - Shots

U.S. doctors can now choose Amjevita instead, the first of several close copies of the popular rheumatoid arthritis drug expected this year. But industry-watchers warn consumer savings may be limited.

Doctors 128
article thumbnail

January 31, 2023: IMPACT Collaboratory Seeks Letters of Intent for Pilot Grants Program

Rethinking Clinical Trials

The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 5A of its Pilot Grants Program. The 1-year pilot grant awards will fund up to $175,000 in direct costs for pilot studies that aim to generate preliminary data for full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons living with Alzheimer disease and related dementias and/or their care partners.

article thumbnail

COVID-19 is a leading cause of death among children, but is still rare

NPR Health - Shots

Children ages 19 and under died from COVID-19 at a rate at 1 per 100,000, making it rare, but still a leading cause of death among that age group.

138
138
article thumbnail

Opinion: How the Biden administration’s Covid preparedness policies could narrow America’s political divide

STAT News

The White House’s Covid Winter Preparedness Plan is a missed opportunity to narrow the divide between Americans. The plan contains important elements to mitigate the anticipated seasonal surge of Covid-19. But it sidesteps the emerging evidence base and President Biden’s pledge to “follow the science.” The current “later Omicron” endemic phase, which began with the rise of the more communicable and less virulent BA.4 and BA.5 subvariants in May 2022, str

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

Nursing home owners drained cash while residents deteriorated, state filings suggest

NPR Health - Shots

As the U.S. government debates whether to require higher staffing levels at nursing homes, financial records show some owners routinely push profits to sister companies while residents are neglected.

Nurses 124
article thumbnail

Medical cannabis for chronic pain may help patients on long-term opioid treatment reduce dosages

Medical Xpress

A new study from New York State and CUNY researchers suggests that receiving medical cannabis for thirty days or more may help patients on long-term opioid treatment to lower their dose over time.

Research 105
article thumbnail

Trying to crack the Nipah code: How does this deadly virus spill from bats to humans?

NPR Health - Shots

Nipah virus, which can rapidly infect and kill members of a community, is carried by bats. Exactly how does it cross over into humans? Researchers in Bangladesh are trying to find out.

Research 115
article thumbnail

Medicines that modify the circadian clock might help heal scars more cleanly

Medical Xpress

Healing often leaves a scar. But the role of the scar itself in healing is often underestimated: a scar that doesn't heal cleanly can be painful or upsetting or affect the range of movement of the affected body part. It may even require further surgical treatment. Now, scientists based at the University of California Los Angeles have found that compounds which target the circadian clock and affect the synthesis of collagen—a protein which is important for skin repair—could improve scar healing.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

STAT+: Alphabet’s laid-off health tech employees on where their work heads next

STAT News

Big Tech has gone through a rough stretch of layoffs — between Meta, Amazon, Alphabet, and Microsoft, 51,000 people have lost their jobs since November 2022, including 12,000 cuts this month at Alphabet alone. Alphabet’s layoffs didn’t hit its health care teams head on: Rather, laid-off employees told STAT, the cuts were scattered across the company.

98
article thumbnail

Planting more trees could decrease deaths from higher summer temperatures in cities by a third, modeling study suggests

Medical Xpress

One third of premature deaths attributable to higher temperatures in European cities during summer 2015 could have been prevented by increasing urban tree cover to 30%, reveals a modeling study published in The Lancet. The study also found that tree cover reduced urban temperatures by an average of 0.4 degrees during the summer.

98
article thumbnail

STAT+: Amgen pricing for its Humira biosimilar may benefit PBMs and insurers more than patients

STAT News

Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited pricing for its biosimilar version of Humira – the world’s best-selling medicine – and the numbers suggest the biggest winners may be health insurers and others in the supply chain, but not patients. Here’s why: The drug company will offer its medication, called Amjevita, at two different discounts – 5% and 55% – off the roughly $80,000 wholesale, or list

article thumbnail

Tuning into brainwave rhythms speeds up learning in adults, study finds

Medical Xpress

Scientists have shown for the first time that briefly tuning into a person's individual brainwave cycle before they perform a learning task dramatically boosts the speed at which cognitive skills improve.

article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

article thumbnail

Town Hall Ventures’ Andy Slavitt on how to invest in Medicaid and health tech

STAT News

SAN FRANCISCO — Part of Andy Slavitt’s core mission at Town Hall Ventures is proving that health tech companies can make a viable business out of reaching low-income people who also face social challenges, like a lack of housing or nutritious food options. It’s a bold assertion that hasn’t been proven out yet, though a handful of Town Hall Ventures’ portfolio companies — including Unite Us and Alphabet spinout Cityblock   — have already achie

article thumbnail

New live bacterial product for stubborn superbug improves quality of life

Medical Xpress

Kevin Garey, a professor of pharmacy practice and translational research at the University of Houston College of Pharmacy, is reporting the first well-controlled study to demonstrate that a microbiome therapeutic, SER-109, is associated with significant quality of life improvement in patients with the debilitating recurrent infection and disease caused by Clostridium difficile (or C. diff).

article thumbnail

STAT+: Medicare may test policy of paying less for accelerated approval drugs

STAT News

A Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that receive so-called accelerated approvals than for drugs that are granted traditional approvals. The Food and Drug Administration uses accelerated approvals to make promising drugs for serious conditions available to patients sooner. The program is widely considered a success and has worked well for many drugs, including the leukemia drug Gleevec , which the FDA approved in 2001 after a review period

Drugs 98
article thumbnail

Quicker time to regulatory submission through improved digital data management

Drug Discovery World

Robust digital workflows can reduce errors and time to compile data leading to greater transparency, faster reporting and help biopharmaceutical companies reach regulatory submission faster. Ken Forman , Senior Director of Product Strategy, IDBS explains. For many start-ups operating on limited investment capital, the ticking clock can be overwhelming.

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.