Drug Discovery and Development Archives - Page 46 of 158

Preparing an IND submission: Here is what drug sponsors should anticipate

[Photo by Chokniti Khongchum on Pexels: https://www.pexels.com/photo/scientist-using-microscope-3938022/]

Before drug sponsors can conduct clinical trials of new therapeutics in the U.S., they must first receive permission from the FDA. The vehicle by which that permission is sought is an Investigational New Drug (IND) application, and once it is submitted, drug development effectively ceases until regulators approve it. The main goal of an IND submission is to present regulators with data that supports a product’s safety for use in humans.

The FDA’s Center for Drug Evaluation and Research (CDER) reviews each application within 30 days. CDER looks for evidence that study participants will avoid “unreasonable risk of significant illness or injury” during early clinical trials and that the study is designed to meet its objectives. INDs that fail to support safety claims adequately can be placed o…

Australia-based Inventia Life Science opens first U.S. location

The Australian biotech Inventia Life Science has opened an office and facility in Wilmington, Delaware.

The new location is based at the Innovation Space, which offers lab space and resources to science startups.

Inventia Life Science had investigated a handful of other regions before settling on Delaware, including Philadelphia, San Diego and Texas.

The bioprinting company has also hired its first U.S. employee, Dwayne Dexter as director of sales and operations. Dexter has a Ph.D. in cellular and molecular biology.

Inventia Life Science recently won AU$35 million in Series B funding. The company has won approximately AU$45 million to date.

Inventia’s Rostrum [Image courtesy of Inventia Life Science]

Inventia focuses on creating life-like 3D human tissues for drug and therapy research. The company’s Rastrum 3D cell culture platform can be used for a variety of biomedical applica…

Multiple COVID-19 vaccine doses associated with lower symptom burden

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. [DoD photo by Lisa Ferdinando.]

A study of essential and frontline workers infected with COVID-19 found that recent vaccination was associated with a variety of benefits. In particular, the workers who had received two or three mRNA COVID-19 vaccine doses had lower viral loads than the unvaccinated. They also had fewer fever and chill symptoms and were less likely to require medical care.

Published in JAMA, the study involved 1,199 participants from Arizona, Florida, Minnesota, Oregon, Texas and Utah. Volunteers were subjected to weekly nasal swabs regardless of symptoms from December 14, 2020, to April 19, 2022. The median age of participants was 41.

The study period encompassed both the delta and omicron waves in the U.S.

The delta variant was more likely to be symptomatic. Only 3.9% of those infected wit…

Metrum Research Group names Michelle Johnson as its new CEO

The biomedical modeling and simulation company Metrum Research Group (MetrumRG) has promoted Michelle Johnson to be its CEO, succeeding founder Marc Gastonguay.

Johnson had served as the chief operating officer of the Ariffville, Connecticut–based company, where she helped assemble the company’s business team. In her new role as CEO, Johnson looks forward to assisting clients in furthering drug development programs with strategic decision-making services. “I am a big believer in the importance of mission and vision,” Johnson said in a recent interview.

Before starting her tenure at MetrumRG, Johnson said she wanted to grow with a company with “endless potential” and where she could “play a part in executing a vision that had a lasting impact on people’s lives.”

“Shortly after I began working at MetrumRG in 2015, I knew this was the place for me,” Johnson said. “I was immediately in awe of …

Athira Pharma’s Phase 2/3 LIFT-AD study wins independent endorsement

The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) will continue its Phase 2/3 LIFT-AD study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease.

The company recently announced an unblinded interim efficacy and futility analysis of LIFT-AD. In addition, an independent data monitoring committee recommended continuing the study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease (AD).

In many ways, the past year has not been kind to Seattle-based Athira. Last October, the company announced that its former CEO Lee Kawas and cofounder would resign in the wake of research misconduct allegations. (Kawas has since established an investment firm known as Propel Bio Partners.) In June 2022, Athira announced disappointing results from the Phase 2 ACT-AD trial involving (ATH-101) in Alzheimer’s disease.

Athira’s share price fell from $34.25 on December 31, 2020 to under $3 per share in…

Cardinal Health exec opens up on diversity in pharma and biotech

Yin Hwa Lai, a director and principal scientist at Cardinal Health, has extensive pharma experience. She now focuses on providing Chemistry, Manufacturing, and Controls (CMC) regulatory consulting and strategy in small molecules, biologics and cell and gene therapy.

In the following interview, Yin touches on what first piqued her interest in the pharmaceutical industry and provides insights into how to encourage more young women to enter the field. She also provides perspective on diversity and inclusion initiatives in the pharma and biotech industry.

The responses have been lightly edited.

What first piqued your interest in the pharma industry?

Yin: I was a curious child. I always was interested in how things work. My grandparents exposed me in childhood to herbs and Chinese medicine. They used herbs to treat symptoms such as cough and fever. That sparked my interest in pharma.

During my undergrad, I majored in chemistry. In my graduate coursewor…

Discovering Antigen-specific Monoclonal Antibodies using Single B Cell Screening

Introduction Since the approval of Orthoclone OKT3 in 1986, more than 100 monoclonal antibodies (mAbs) have been approved by the Food and Drug Administration (FDA) to treat a variety of diseases ranging from autoimmune disorders, infectious diseases, and cancer [1-2]. In the context of the current COVID-19 pandemic, it’s crucial that these biologics are developed rapidly and efficiently. Among various antibody discovery approaches, including hybridoma technology, single B cell screening is a powerful and efficient strategy for generating antigen-specific mAbs based on the direct amplification of the VH and VL regions encoding genes from single B cells [3-4]. Notably, single B cell screening has various advantages that include maintaining the naïve VH/VL pairing, requiring relatively few cells, and the ability to discover antibodies against challenging targets.

Single B Cell Screening Technologies Single B cell screening technologies have emerged and evolved rapidly ov…

Meet the startup aiming to treat opioid use disorder with a kratom-derived drug

Atai Life Sciences (Nasdaq:ATAI) recently announced positive results from a Phase 1 study testing KUR-101 for opioid use disorder. KUR-101 is an oral formulation of the kratom alkaloid mitragynine.

Atai subsidiary Kures is leading the effort to test the potential of mitragynine, which acts as a partial mu-opioid receptor agonist.

Kratom itself is a source of controversy. Proponents note that the supplement, which is native to Southeast Asia, is a safe treatment for everything from anxiety to chronic pain and opioid use disorder. Conversely, critics maintain that kratom is dangerous. The FDA was warned consumers against it. Similarly, calling kratom “unsafe and ineffective,” the Mayo Clinic recommended patients “work with your doctor to find other treatment options.” A number of states have either banned or restricted kratom. Meanwhile, Thailand, where the plant is native, recently decriminalized it.

Meanwhile, scientists continue to study kratom and its …

How pharma professionals can engage physicians for optimal outcomes

[Image by Yerson Retamal from Pixabay]

It’s no secret that the pharma industry is evolving at a rapid pace, with technological advances and new pharmacy options impacting consumer preference every day. And with the industry expected to grow swiftly in the coming years, pharmaceutical companies will need to progress along with that growth to engage key audiences.

Big industry players know this is true, with major firms increasing their budget for marketing more so than for research and development initiatives — highlighting the importance these companies place on communicating their work to the general public. But what is the most strategic way pharma companies can spend these dollars? The answer lies in a surprising place: leveraging physician insights and influence to create authority and stand out in a crowded marketplace.

Emergence of the digital physician

Reverberations from the COVID-19 pandemi…

Pfizer shares preliminary findings on omicron-adapted bivalent COVID-19 booster

Early data from a Pfizer-BioNTech (NYSE:PFE/Nasdaq:BNTX) Phase 2/3 study (NCT05472038) indicate that their updated omicron BA.4/BA.5-adapted bivalent COVID-19 booster works as intended.

After drawing sera from booster recipients seven days after administration, investigators concluded that a single 30-µg booster dose increased omicron BA.4/BA.5 neutralizing antibody levels. In addition, they note that the updated vaccine potentially offers more robust protection against those omicron sub-lineages than the original vaccine in adults.

The updated vaccine also appeared to be well tolerated, with a safety profile similar to the companies’ first COVID-19 vaccine.

Pfizer and BioNTech will present additional data on the bivalent vaccine one month after administration in the coming weeks.

The study broke participants into two age groups, with the first aged 18 to 55 years old and the second group older than 55. There were 40 volunteers in each age gro…

FDA clears Moderna and Pfizer-BioNTech bivalent COVID-19 boosters in children

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old.

FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.

MRNA shares were up 8.28% to $130.72. PFE shares were mainly flat, holding steady at $42.03. BioNTech, which worked with Pfizer in developing the original and updated mRNA vaccine, saw its stock increase 5.53% to $136.65.

The bivalent vaccines from Moderna and Pfizer-BioNTech include an mRNA component shared between the omicron variant BA.4 and BA.5 lineages.

FDA’s decision to authorize the bivalent Pfizer-BioNTech COVID-19 vaccine booster overrides its prior authorization of the companies’ monovalent booster in children aged five to 11.

The revised Moderna authorization will make its 25 μg bi…

Why Psychogenics and Emyria are collaborating to examine MDMA-inspired compounds

CNS-focused contract research organization PsychoGenics has forged a collaboration with clinical-stage biotech Emyria Ltd to study five novel MDMA-inspired drug candidates for severe neuropsychiatric conditions.

Emyria and its partner, the University of Western Australia, will initially screen five novel MDMA analogs with PsychoGenic’s computer vision and AI-based testing platform. The organizations expect the alliance to inform and predict the clinical effects of new drug compounds, including Emyria’s MDMA-inspired library.

PsychoGenics will compare the MDMA-based compounds to known reference drug libraries.

The companies anticipate that the alliance will facilitate the accelerated development of the MDMA-inspired library that holds potential for conditions ranging from Parkinson’s disease to post-traumatic stress disorder (PTSD).

PsychoGenics and Emyria will work collaboratively before exploring drug discovery and commercializa…