MindMed announces Phase 1 study of MDMA-like substances

On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers. 

MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early evidence suggests that its MM-402 MDMA-based drug candidate can reduce social impairment. 

Like LSD, MDMA (methylenedioxy-methamphetamine) is a Schedule I drug. While the U.S. government outlawed LSD in 1968, MDMA was banned in 1985. 

The FDA, however, is purportedly considering approving MDMA as a treatment for post-traumatic stress disorder in the coming years. 

Matthias Liechti, principal investigator of the Phase 1 study on MDMA-like substances on behalf of MindMed, noted that the amphetamines MDMA and methylenedioxyamphetamine (MDA) can have mixed subjective effects — especially at the onset of response…

Read more
  • September 21, 2022
  • 0

Women in Pharma: AstraZeneca executive vice president Susan Galbraith has helped develop seven blockbuster drugs

Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said.

After following this passion and becoming a clinical oncologist, Galbraith had the opportunity to undertake a Ph.D. at the University of London, where she researched a vascular-targeting molecule. “Near the end of my Ph.D., the molecule I was working on was licensed to Bristol Myers Squibb, and I was approached with an opportunity to join the company,” she said. “ So, in 2001, I moved across the Atlantic with my family and entered the pharmaceutical industry.”

Shortly after Galbraith joined the industry, work on the molecule was halted due to a safety signal. “At this point, I could have headed back to clinical research, which at the time was the les…

Read more
  • September 21, 2022
  • 0

Pfizer and AI firm CytoReason extend alliance

The computational disease model developer CytoReason has announced that it has entered into a multi-year partnership with Pfizer (NYSE:PFE) that is potentially worth $110 million over the next five years. 

In the recent partnership, Pfizer will make a $20 million equity investment in CytoReason. The company will also obtain options to license platform and disease models from Tel Aviv–based CytoReason. 

The new collaboration will center around Pfizer’s focus on developing a variety of disease models and high-resolution models for several therapeutic areas.

The two companies began working together in 2019. 

Pfizer has used CytoReason’s biological models of the immune system for drug development efforts related to immune-mediated and immuno-oncology diseases. 

CytoReason reports that Pfizer has used its platform for R&D programs related to more than 20 diseases. 

“CytoReason’s biological data allows us to gai…

Read more
  • September 20, 2022
  • 0

Ohio grows into a globally recognized R&D hub

Downtown Cleveland skyline in 2022. Photo by Paul J. Heney.

With top-notch universities, federal research institutes, leading companies from nine major industry sectors, and 14 top-ranked hospital systems, Ohio is a “quiet giant” of innovation in industrial sectors and life science. Ohio has the fifth-highest number of Fortune 500 and Fortune 1000 companies — and is home to more than 120 NYSE/Nasdaq companies with a combined market capitalization exceeding $1 trillion.

Ohio government executives attribute the state’s growth to government actions that help businesses succeed and the research and development (R&D) investments that lay the foundation for innovation in the Midwest.

Get the full story from our sister site, R&D World. 

Read more
  • September 20, 2022
  • 0

Leaving DNA contamination at the lab bench

Photo by Sangharsh Lohakare on Unsplash

Cell and gene therapies are ushering in a new era of promise across a multitude of therapeutic applications, offering hope for overcoming previously insurmountable medical challenges. As a result, the sector has grown immensely, with more than 3,500 cell and gene therapies currently in development, from preclinical to pre-registration stages. Based on the current pipeline and clinical success rates of products, the FDA estimates that 10 to 20 new cell and gene therapy products will be approved annually by 2025. 

While progress is certainly robust, these drugs present novel challenges and safety concerns that continue to threaten the pace of development and approval. Every stage of the complex, multi-step process of manufacturing cell and gene therapies introduces potential sources of contamination, even under carefully controlled conditions. These contaminants threaten…

Read more
  • September 20, 2022
  • 0

Johnson & Johnson launches Bay Area science and technology campus

Johnson & Johnson (NYSE:JNJ) has opened an almost 200,000 ft2 science and technology campus in the San Francisco Bay Area. The new facility more than doubles the presence of the company in the Bay Area, which has been a hub for life sciences innovation for decades. Up to 400 employees will work at the facility.

“This campus is our downpayment in our ability to innovate for the future,” said Johnson & Johnson CEO Joaquin Duato at an opening ceremony for the facility in Brisbane, California.

The new science and technology campus will unite scientific and technological capabilities by housing Janssen Research and Development (R&D), Johnson & Johnson Innovation and Johnson & Johnson Technology under one roof.

The new site was designed to spur internal and external collaboration, said James Merson, global therapeutic area head for infectious diseases and site lead.

“The San Francisco Bay Area is unique in the respe…

Read more
  • September 20, 2022
  • 0

How effective is ketamine for depression? 

[Image by Lucija Rasonja from Pixabay]

First synthesized in 1962, the dissociative anesthetic ketamine is rapidly growing in popularity for its off-label use in treating depression and mood disorders. In recent years, hundreds of clinics across the U.S. have begun offering ketamine for depression, anxiety and other mood disorders.  

The surge in interest has also attracted startups such as Mindbloom and Field Trip Health. At the same time, Janssen (NYSE:JNJ) scored FDA approval for the ketamine enantiomer Spravato (esketamine) for depression in 2019. 

Impressive but limited data

While evidence is building that indicates that ketamine is effective against depression, the level of evidence is frequently limited to small clinical trials, case reports and anecdotes. “It’s really difficult to tease apart what’s happening in these [ketamine] studies because there’s no standard protocol,&…

Read more
  • September 19, 2022
  • 0

Women in Pharma: Ferring Pharmaceuticals’ CSO on what inspires her

Dr. Elizabeth Garner

Ferring Pharmaceuticals Chief Scientific Officer Dr. Elizabeth Garner guides clinical development, medical affairs, pharmacovigilance, project planning and regulatory affairs.

Garner has almost 30 years of experience in medicine and industry. Before joining Ferring in 2022, Garner held chief medical officer roles for biotech firm ObsEva and women’s healthcare company Agile Therapeutics. Earlier, she held leadership roles in medical affairs at Myriad Genetics Laboratories and clinical development at Abbott Laboratories and Merck Research Laboratories.

In the following interview, Garner shares what attracted her to drug discovery and development, how she addressed the toughest challenge of her career and the importance of mentorship.

What first drew you to drug discovery and development? When did you first know you wanted to be in the industry?

Garner: As a woman who was born…

Read more
  • September 16, 2022
  • 0