Thu.Jul 07, 2022

article thumbnail

After a lengthy drought, could biotech M&A be on the upswing?

Bio Pharma Dive

With at least 14 buyouts worth $50 million or more, the second quarter was one of the busiest three-month periods for acquisitions in recent years. Some industry watchers expect that pace to continue.

323
323
article thumbnail

Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.

Antibody 264
Insiders

Sign Up for our Newsletter

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

article thumbnail

Adverum cuts jobs, restructures to give eye gene therapy another shot

Bio Pharma Dive

A year after reporting side effects “not seen before in ocular gene therapy” in a clinical trial, the biotech is eliminating 38% of its workforce to save cash while it runs a new study.

article thumbnail

Cell and gene therapies: why advanced medicines call for specialised logistics

Pharmaceutical Technology

Genetic mutations, both germline and acquired, are behind a large proportion of the most debilitating and sometimes life-threatening human diseases. But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure the

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

As Merck closes in on Seagen, the FTC nears a key test on pharma deals

Bio Pharma Dive

An acquisition reportedly worth $40 billion or more and potentially signed within weeks could draw notable scrutiny from regulators and force the companies to divest certain drug programs.

article thumbnail

These Microbes Could Make You More Attractive to Mosquitoes, Mice Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Mosquitoes are the world’s deadliest animal. Over 1 million deaths per year are attributed to mosquito-borne diseases, including malaria, yellow fever, dengue fever, Zika, and chikungunya fever. [link] How mosquitoes seek out and feed on their hosts are important factors in how a virus circulates in nature. Mosquitoes spread diseases by acting as carriers of […].

More Trending

article thumbnail

FDA grants priority review to Roche’s Lunsumio for follicular lymphoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). These patients should have received a minimum of two prior systemic therapies. A CD20xCD3 T-cell engaging bispecific antibody, Lunsumio can act on CD20 present on the B-cell surface and CD3 on the T-cell surface.

article thumbnail

July 7, 2022: Patient-Centered Outcomes Core Values Cross-Core Collaboration and Real-World Knowledge

Rethinking Clinical Trials

Dr. Emily O’Brien. In connection with the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we asked Dr. Christy Zigler and Dr. Emily O’Brien to reflect on the role of the Patient-Centered Outcomes Core in helping the Demonstration Project teams plan and implement their trials, and to discuss their focus for the Core’s future contributions to pragmatic clinical trials.

article thumbnail

COVID-19 health concern declines in June: Poll

Pharmaceutical Technology

The health concern over COVID-19 in June 2022 decreased from May 2022. It averaged at 23.9%, declining from 25.3% recorded in May 2022, shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly concern

147
147
article thumbnail

Health ministry releases 9th edition of IP containing 3,152 monographs

AuroBlog - Aurous Healthcare Clinical Trials blog

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution specifications […].

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

Opinion: The UK is better off for Boris Johnson’s departure

Pharmaceutical Technology

It is said that leaders become obsessed with legacy when the curtain begins to fall on their time in power – but leaders don’t write their own history. Although Tony Blair may want to be remembered for public sector reform, peace in Northern Ireland and a reduction in child poverty, any biography of the man will be dominated by the catastrophic consequences of his decision to support the US-led invasion of Iraq.

article thumbnail

Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial

XTalks

Lenire is a non-invasive, bimodal neuromodulation device that works by using two paired stimuli to stimulate nerves for tinnitus treatment. Photo courtesy Neuromod Devices Ltd. Tinnitus — frequently referred to as “ringing in the ears” — happens when no corresponding external sound exists. People with tinnitus may not only have the sensation of ringing in their head, but also other sounds like hissing, buzzing, whistling or chirping.

article thumbnail

Preventing the next pandemic: Supporting early-stage R&D

pharmaphorum

In the second of a three-part series, Ben Hargreaves looks at the importance of early-stage research into various emerging infectious disease threats and how it saved precious time in the work to develop a working vaccine during the current pandemic. When COVID-19 first emerged, scientists cautioned that developing an effective and safe vaccine could take longer than the commonly estimated figure of a year.

article thumbnail

New Subway Sandwiches Coming as Part of Menu Update

XTalks

Subway, the submarine sandwich chain, is adding new Subway sandwiches to its menu for the first time in its nearly 60-year history. The chain introduced a dozen new Subway sandwiches that are a combination of the brand’s signature meats, cheeses, vegetables and sauce ingredients on freshly baked bread in a new line called the Subway Series. The Subway Series also shifts away from the chain’s long-standing model that involved ordering build-your-own sandwiches.

Sales 98
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

Diabetes patients to benefit from £10m heart disease data investment

Pharma Times

The British Heart Foundation’s project will accelerate the search for better prevention and treatment of diabetes

120
120
article thumbnail

The North American Menopause Society releases its 2022 Hormone Therapy Position Statement

Scienmag

CLEVELAND, Ohio (July 7, 2022)—In the 20 years since the Women’s Health Initiative, hormone therapy remains one of the most hotly debated topics around the treatment of such bothersome menopause symptoms as hot flashes. In an effort to provide the most up-to-date, scientifically based information on the topic, The North American Menopause Society (NAMS) has […].

article thumbnail

NICE recommend’s use of Leo Pharma’s Adtralza

Pharma Times

The therapy is for moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic treatment

116
116
article thumbnail

Narwhals show physiological disruption in response to seismic survey ship noise

Scienmag

The reaction of narwhals to the loud noise from seismic air guns used in oil exploration involves a disruption of the normal physiological response to intense exercise as the animals try to escape the noise. The overall effect is a large increase in the energetic cost of diving while a paradoxically reduced heart rate alters […].

89
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

Researchers Identify Key to Developing Effective Staph Vaccines in Humans

BioSpace

Facing the looming threat of AMR, researchers finally have a new clue as to why attempts to develop an effective S. aureus vaccine have failed. BioSpace spoke with the team leaders.

article thumbnail

Bioproduction Breakthrough: New method for developing Pichia pastoris yeast strains with high productivity of useful proteins

Scienmag

A collaboration including researchers from Kobe University, University of Tokyo and Tohoku University has successfully identified and disrupted genes in the yeast Pichia pastoris (1) in order to increase its secretory production of useful proteins (2). Through a series of processes that involved combining gene disruptions and then serially cultivating (*3) the resulting multiple disruption […].

Protein 88
article thumbnail

Sema4, Avera Health partner on precision cancer care initiative

Outsourcing Pharma

The health care system and analytics company are joining on the ASAP study, a program that constitutes a five-year commitment to advancing cancer solutions.

article thumbnail

Carbon conservation efforts would be enhanced by highlighting threatened forest primates

Scienmag

CORVALLIS, Ore. – Efforts to conserve the carbon stored in tropical forests would be enhanced by linking the work to the charismatic, threatened primates that live there, Oregon State University ecologists assert today in a paper published in the Proceedings of the National Academy of Sciences. Credit: Matt Betts, Oregon State University CORVALLIS, Ore. – […].

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

Professional patient enrollment increases willingness to participate in a clinical trial

Clairnes

The post Professional patient enrollment increases willingness to participate in a clinical trial appeared first on Clinical Trial Recruitment & Management Services.

article thumbnail

Ultrasound imaging can help solve the Alzheimer’s disease “chicken and egg” problem

Scienmag

Understanding the relationship between Alzheimer’s disease and the brain’s vascular system — its complex network of vessels and veins — is a longstanding challenge for scientists. Credit: Beckman Institute for Advanced Science and Technology. Understanding the relationship between Alzheimer’s disease and the brain’s vascular system — its complex network of vessels and veins — is […].

article thumbnail

GoodRx Pharma Manufacturer Solutions: Partnering for Patient Access and Affordability

Drug Channels

Today’s guest post comes from Akeel Williams, VP of Strategy and Operations, Pharma Manufacturer Solutions at GoodRx. Akeel provides an overview of GoodRx’s Pharma Manufacturer Solutions business. He describes how GoodRx leverages its consumer reach to help biopharma companies boost awareness and utilization of manufacturers’ copay assistance programs.

article thumbnail

Balancing protein in your diet could improve water quality

Scienmag

Balancing how much protein you eat with the amount your body needs could reduce nitrogen releases to aquatic systems in the U.S. by 12% and overall nitrogen losses to air and water by 4%, according to a study from the University of California, Davis. Credit: Courtesy Maya Almaraz Balancing how much protein you eat with […].

Protein 85
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

Two-Thirds of 2021 FDA-Approved Drugs Supported with Genetic Data

BioSpace

Last year, the FDA's Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.

article thumbnail

ORNL’s Wagner, Curran elevated to Senior Members of IEEE

Scienmag

Two Oak Ridge National Laboratory researchers have been elevated to the grade of senior member of the Institute of Electrical and Electronics Engineers (IEEE). Robert Wagner, division director for the Building Transportation Science Division, and Scott Curran, group leader for Fuel Science and Engine Technologies Research, earned the recognition for making significant contributions to the […].

article thumbnail

Adverum Slashes Workforce By 38%, Hones In On Eye Disease Candidate

BioSpace

Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.

Drugs 98
article thumbnail

The health effects of hookahs

Scienmag

Led by Ziyad Ben Taleb, assistant professor of public health in the College of Nursing and Health Innovation and director of UTA’s Nicotine and Tobacco Research Laboratory (NTRL), the team will study how the size of a hookah device—also known as a water pipe—impacts its user’s health. It’s an area of research that Ben Taleb […].

Nurses 84
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.