Drug Discovery and Development Archives - Page 47 of 159

What is the role of preparation and integration in psychedelic therapy?

[Photo by Polina Kovaleva]

The organizations that have made the most progress in the clinical development of psychedelic agents — broadly defined — have tended to prioritize psychological support before and after drug administration.

A position statement from the the American Psychiatric Association notes that, in preliminary research, psychedelics “have generally been combined with structured psychotherapy protocols proposed by investigators as integral to achieving full therapeutic benefit and ensuring participant safety and wellbeing.”

According to Doug Drysdale, CEO of Cybin (NYSEAMERICAN:CYBN), such support shouldn’t be confused with psychotherapy. “But getting the patient prepared is important,” Drysdale added. Such sessions can help set patients’ expectations, so they are not shocked or surprised during the psychedelic therapy session. Such sessions can also help…

FDA hands Minerva Neurosciences refusal to file letter for its roluperidone NDA for schizophrenia

The biopharma Minerva Neurosciences (Nasdaq:NERV) announced that it had received a refusal to file letter from the FDA for its New Drug Application (NDA) for roluperidone.

The NDA covered the use of the drug candidate as a treatment for the negative symptoms in schizophrenia patients. Negative schizophrenia symptoms can include social withdrawal, mood flatness and depression.

Drug candidates that get a refusal to file letter have slim chances of winning FDA approval.

Roluperidone is a 5-HT2A and sigma2 receptor antagonist.

FDA informed Burlington, Massachusetts–based Minerva Neurosciences that the company can ask for a Type A meeting to review the content of the refusal to file letter. Accordingly, the company plans to request such a meeting.

“We are disappointed that the FDA has not accepted our NDA for roluperidone,” said Remy Luthringer, CEO of Minerva Neurosciences. “Our goal remains to provide a new and much-needed therapeutic option t…

FDA adcom recommends withdrawal of Covis Pharma’s preterm birth drug Makena

FDA’s independent Obstetrics, Reproductive, and Urologic Drugs Advisory Committee has voted almost unanimously that FDA should withdraw its approval of Makena (hydroxyprogesterone caproate injection). A total of 14 of the 15 committee members supported the withdrawal of the drug. In addition, all of the committee concluded that the postmarket study for Makena did not show a benefit.

Makena is the only FDA-approved therapy with an indication of reducing the risk of preterm birth in pregnant women who have had an earlier spontaneous preterm birth.

The drug has a complicated regulatory history. In 2006, Adeza filed a new drug application for the drug, which was then known as Gestiva. Adeza filed a new drug application for the drug, which was then known as Gestiva. The drug would ultimately end up in the hands of Covis and be rebranded as Makena.

The launch of Makena was delayed until 2011.

A postmarket study would eventually conclude that the drug wa…

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…