Drug Discovery and Development Archives - Page 53 of 158

Clearmind Medicine reports positive preclinical data for cocaine addiction treatment

Clearmind Medicine (CSE:CMND) recently announced additional positive preclinical data related to its psychedelic molecule 5-methoxy-2-aminoindane (MEAI) for treating cocaine addiction.

Professor Gal Yadid and a group of researchers from the Gonda Multidisciplinary Brain Research Center located at Bar Ilan University (Ramat Gan, Israel) performed the study based on the self-administration paradigm, which is an operant-conditioning-based model for investigating drug addiction.

In the study, rats were trained to self-administer cocaine and underwent an extinction phase in which researchers removed cocaine availability. Researchers then provided MEAI to the test group. Afterward, the researchers offered a single administration of cocaine to the rats who

were later returned to their self-administration habitat.

Animals that received MEAI had a substantially lower likelihood of attempting to self-administer cocaine.

FDA greenlights bivalent COVID-19 boosters from Pfizer and Moderna

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX).

The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old.

Individuals in those age groups who have waited at least two months after receiving a second or third dose of a monovalent COVID-19 vaccine are eligible for the bivalent COVID-19 boosters.

The updated Moderna mRNA-1273.222 and Pfizer/BioNTech BNT162b5 vaccines could be available at U.S. vaccination sites in the coming days.

The updated COVID-19 vaccines encode the spike protein from the original SARS-CoV-2 strain and the BA.4 and BA.5 lineages of the omicron variant.

According to data from Walgreens, the omicron variant is responsible for nearly 100% of COVID-19 infections in the U.S.

Clinical trial data suggeste…

How Pfizer’s alliance with Morgan State University prioritizes diversity in vaccine development

Pfizer (NYSE:PFE) and Morgan State University have unveiled a novel program known as the Doctor of Public Health (DrPH) Fellowship in Vaccines Medical Development. A central aim of the program is to foster diversity in vaccine development.

In particular, the two-year DrPH program aims to increase the number of minority scholar-practitioners involved in vaccine development. In addition, the initiative will offer fellows training and networking opportunities to pave the way for leadership roles in the biopharma industry.

The program officially launched today.

Ronika Alexander-Parrish

Ronika Alexander-Parrish, a clinical scientist at Pfizer and founding director of the DrPH Fellowship, said the idea came out of brainstorming that began in the early days of the COVID-19 pandemic, which highlighted healthcare inequity.

Alexander-Parrish said the company’s leadership embraced her vis…

FDA reportedly will soon authorize updated COVID-19 boosters

The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports.

The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day.

To authorize the omicron-specific COVID-COVID-19 boosters, FDA will likely review data from the first-generation mRNA COVID-19 vaccines, investigational omicron-specific boosters based on the BA.1 variant and preclinical research.

Moderna (Nasdaq:MRNA) is developing an updated COVID-19 vaccine, as are Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX).

The agency hopes the boosters will offer a similar level of protection against SARS-CoV-2 that COVID-19 vaccines provided when they were first authorized in late 2020. At that point, the novel coronavirus had mutated relatively little, resulting in strong vaccine-induced immunity.

The emergence of m…

Using real-world evidence in clinical trials: Challenges and opportunities

Photo by Joshua Sortino on Unsplash

The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from participants in these trials would be evaluated to determine whether the product in question should be approved for commercial use.

In recent years, however, the exponential increase in patient data recorded by digital devices has raised the possibility that real-world data (RWD) and real-world evidence (RWE) may be used to augment clinical trial data.

But what are RWD and RWE? Are they the same thing? And how could they effectively be integrated into clinical trials to produce better outcomes for consumers?

Here’s how the FDA defines RWD and RWE:

Real-world data relate to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. RWD can come from mul…

Genentech’s clinical supply center rethinks biologics manufacturing

Genentech CSC building exterior, South San Francisco, California [Image courtesy of Genentech]

Genentech has opened a novel clinical supply center at its birthplace in South San Francisco.

The planning for the new $250 million center began in 2019 when Genentech, a member of the Roche Group, began earnest efforts to imagine what the future of biomanufacturing looks like.

“We were looking at where we are going in the industry,” said Jeff Davis, the executive director of the Clinical Supply Center (CSC). “And what does Genentech need? What are the trends across the industry?”

One of those trends is prioritizing personalized medicines focused on small patient groups. Genentech thus determined it needed to supplement its large-volume manufacturing with more agile facilities. It began planning the construction of a fast, agile facility that can produce distinct batches on differe…

Incyte wins second FDA indication for FGFR inhibitor Pemazyre

FDA has approved the selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinib) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

The drug, developed by Incyte (Nasdaq:INCY), first won approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

The latest indication, MLNs with FGFR1 rearrangement, covers an extremely rare and aggressive form of blood cancer.

A 2019 article in Frontiers in Oncology noted that there had been approximately 100 cases of the cancer reported to date.

“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, Incyte CEO, in a news release. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued…

The data to solve many pharmaceutical research problems already exists. We just need to harness it.

[Image courtesy of ipopba via iStock Photo]

In searching for new therapies, pharmaceutical research teams worldwide are conducting experiments daily and generating knowledge. Thanks to this constantly expanding pool of scientific data, we are starting projects with access to more information than ever before.

Data is good. The right data is better. But finding the right data is no easy task. Inaccessible data sources, the growing complexity of search terms required to attain appropriate results, and the multitude of databases available means that finding data – and then applying it to inform research – is taking up more and more valuable researcher hours. As a result, 80% of researcher time is dedicated to acquiring and reformatting data; time that could be much better spent on analysis and developing scientific insights.

It is, however, essential. What’s needed are methods to accelerate the search …

Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

MindMed launches Phase 2b to study LSD in generalized anxiety disorder

Psychedelic medicine firm MindMed (OTCMKTS:MMDCF) has dosed the first patient in a Phase 2b dose-optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD).

The study will test the potential of LSD to treat general anxiety disorder (GAD), which affects about 3% of the population.

While LSD emerged as the definitive psychedelic compound of the 1960s, psilocybin has more recently emerged as a more popular recent focus of clinical trials. LSD arguably has seen more cultural backlash than psilocybin.

Unravelling psychedelic mysteries

Evidence is mixed regarding LSD’s potential to treat mood disorders. Some LSD users report obtaining life-changing insights from their experiences. For instance, the actor Cary Grant reported experiencing an “immeasurably beneficial cleansing of so many needless fears and guilts” after ingesting LSD an estimated 100 times in a therapeutic setting from 1958 to 1961. Conve…

Pulmonary Fibrosis Foundation’s latest registry offers research opportunities

The Pulmonary Fibrosis Foundation (PFF) has launched the PFF Community Registry to facilitate research on pulmonary fibrosis (PF) and interstitial lung disease (ILD).

The PFF Community Registry collects self-reported data from patients, nonprofessional caregivers and family members via an online portal. Participation is voluntary.

“There’s a research opportunity to see if there are any differences in how patients perceive their diagnosis and care relative to how physicians input that data within the medical chart,” PFF Registry VP Junelle Speller said.

The Pulmonary Fibrosis Foundation is enrolling individuals in the Community Registry, including lung transplant recipients and patients diagnosed with pulmonary fibrosis or interstitial lung disease, Speller said. The lung transplant group is a new cohort for the organization.

The organization plans on conducting follow-up surveys at six-month intervals. “We will check in on …

Ketamine for depression: Is disassociation really necessary?

[Image courtesy of PubChem]

Ketamine has emerged as a quick-acting antidepressant in recent years. While use of the dissociative anesthetic for depression has exploded, hurdles remain.

A single ketamine infusion can cost $400 or more in the U.S. Ketamine can also cause significant transient increases in blood pressure.

Furthermore, higher doses of the drug can lead to pronounced states of disassociation, which can induce anxiety in some individuals. Doctors generally recommend that patients receiving ketamine avoid driving or operating machinery for some time following a treatment session.

Whether ketamine’s dissociative side effects are necessary for its antidepressant effects remains unclear.

Dissociating from dissociative side effects

“The dissociative side effects have had a negative impact on the uptake of this [ketamine-based] treatment approach,” said Dr. Hans Erikss…