Drug Discovery and Development Archives - Page 48 of 158

How should ketamine be used for depression?

[Image courtesy of PubChem]

Proponents of ketamine for depression describe its remarkable ability to catalyze improvements in many patients’ mood disorders such as depression and anxiety.

However, the question of how the dissociative anesthetic ketamine should be used in the long-term to manage mood order symptoms is less clear.

Pharma efforts in ketamine for depression

First synthesized in 1962, ketamine’s patent expired in 2002. Janssen, however, managed to secure patent protection for Spravato, the S-enantiomer of ketamine that won FDA approval in 2019.

Janssen has not disclosed sales figures for its nasal spray-based Spravato, but GlobalData projects it will generate global sales of roughly $383 million by 2029.

Seelos Therapeutics, is developing intranasal racemic ketamine for acute suicidal ideation and behavior in patients with major depressive disorder (MDD). The company …

GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer

[Image courtesy of GSK]

GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients.

The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy. A blinded independent central review evaluated the study’s results with RECIST v1.1 criteria.

AnaptysBio (Nasdaq:ANAB), a clinical-stage biotech, originally developed dostarlimab, which it later licensed to Tesaro, which GSK acquired in early 2019.

The randomized, double-blind PERLA study enrolled 243 patients.

GSK notes that the trial is the most extensive global head-to-head study of programmed death receptor-1 (PD-1) inhibitors in patients with metastatic non-squamou…

Pfizer finalizes acquisition of Global Blood Therapeutics

In August, Pfizer (NYSE:PFE) announced its plan to acquire Global Blood Therapeutics (GBT) for $68.50 per share, or roughly $5.4 billion.

Today, the company announced that it had finalized the acquisition, giving it access to GBT’s portfolio of drug candidates for sickle cell disease (SCD).

The GBT acquisition also adds Oxbryta (voxelotor), a novel sickle hemoglobin inhibitor, to its portfolio. Oxbryta has won marketing approval in the U.S., the European Union, United Arab Emirates, Oman and Great Britain.

In 2021, Oxbryta generated $194.7 million in sales, representing a 57% year-over-year increase.

GBT won Orphan Drug and Rare Disease designations from FDA for GBT021601 (GBT601) and inclaclumab, respectively.

Pfizer has developed therapies for rare hematologic diseases for three decades.

The company has been on a spending spree of late.

In March, Pfizer wrapped up a $6.7 billion acquisition of Arena Pharmaceuticals. Two mont…

Atai Life Sciences launches Phase 1 study of buccal and IV synthetic DMT

Atai Life Sciences (Nasdaq:ATAI) has dosed the first patient in a Phase 1 single-ascending-dose study focused on VLS-01, a synthetic form of N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD).

While many companies in the psychedelic industry first focused on psilocybin, a growing number of players are beginning to explore the therapeutic potential of DMT, a short-acting naturally-occurring psychedelic.

The active component of the South American psychedelic brew ayahuasca, DMT, is a 5-HT2A receptor agonist like psilocybin and LSD.

Unlike other classic psychedelics, DMT is not orally active when administered alone. Ayahuasca contains a monoamine oxidase inhibitor to protect DMT from metabolism.

The clinical-stage company Algernon Pharmaceuticals (CSE:AGN; Frankfurt:AGW0; OTCQB: AGNPF), for instance, has commenced a Phase 1 study of IV DMT in patients ischemic stroke patients.

Although treatment-resistant depression lacks a …

DMT pioneer Rick Strassman weighs in psychedelic hope and hype

[Image courtesy of PubChem]

Interest in the therapeutic potential of psychedelics may have exploded in recent years, but the field will likely see “a lot of separating the wheat from the chaff,” said Dr. Rick Strassman, a professor at the University of New Mexico School of Medicine and author of “DMT: The Spirit Molecule” and “The Psychedelic Handbook.”

In the 1990s, Strassman conducted pioneering research on the psychedelic DMT (N,N-dimethyltryptamine), which is found in many plants and animals.

While the number of psychedelic companies has exploded recently, the herd may already be thinning. Several public companies in the space have seen their valuations plummet over the past year.

“I think there’ll be more consolidation,” Strassman predicted. “There will be just a handful of players in the end.”

Strassman recommends that c…

Eisai unveils new facility for injectable drug formulation research

Eisai (OTCMKTS:ESALY) has announced that it has completed the construction of a new research building dedicated to the formulation of injectable drugs at the Kawashima Industrial Park located in Gifu Prefecture, Japan.

The Eisai Medicine Innovation Technology Solutions (EMITS) facility will serve as Eisai’s global headquarters for formulation and research.

Traditionally focusing on small molecules, Eisai has ramped up its focus on drug discovery targets to include antibodies, antibody-drug conjugates (ADCs) and nucleic acid drugs.

The EMITS facility will conduct research on injectable drug formulation and drug delivery systems. In particular, Eisai plans to explore liposomal and lipid nanoparticle formulations.

Eisai plans to use AI to enhance drug formulation.

It also aims to manufacture investigational injectable drugs at the facility for clinical trials and develop rapid microbial testing methods for microbiological control and ste…

Illumina’s new NovaSeq X can sequence 20,000 genomes a year

[Image from Illumina]

Illumina (Nasdaq:ILMN) announced last week that it launched its new NovaSeq X series of production-scale sequencers.

San Diego-based Illumina said its new sequencers “push the limits of what is possible with genomic medicine.” NovaSeq X and NovaSeq X Plus offer faster, more powerful and more sustainable sequencing. The latter can generate more than 20,000 whole genomes per year.

At a clip about 2.5 times the throughput of prior sequences, this accelerates genomic discover and clinical insights, Illumina said. The company redesigned every dimension of its sequencers with what it calls revolutionary new technology to increase speed, scale, accuracy and sustainability.

The company launched a fundamentally new sequencing by synthesis (SBS) chemistry. Formerly known as Chemistry X and now called XLEAP-SBS, it engineered it for twice the speed and up to three times bette…

Onsero aims to develop psychedelic-inspired antidepressant without the hallucinations

What if a psychedelic-inspired compound could treat mood disorders without causing users to hallucinate?

Boston-based Onsero is exiting stealth mode, announcing its intent to develop a psychedelic-inspired antidepressant that offer therapeutic benefits without causing hallucinations.

Such a drug would avoid the shadow side of classic psychedelics such as LSD and psilocybin.

Classic psychedelics continue to be Schedule I substances, which the federal government deems as having “no currently accepted medical use and a high potential for abuse.”

Some individuals who try psychedelics can have intense fear-ridden experiences while the drug is in their system. Others can have hallucinogen-persisting perception disorder (HPPD), a condition in which perceptual changes continue after the effects of the drug have worn off.

Finally, a significant number of people continue to view psychedelics with skepticism. A 2020 survey found that fo…

Janssen sees Blood Cancer Awareness Month as an opportunity to close the clinical trial diversity gap

Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September.

Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma each year, according to the American Cancer Society.

In addition to highlighting the incidence of hematologic malignancies, Blood Cancer Awareness Month offers an opportunity to provide education about the need for improved clinical trial diversity. While the industry has made strides recently, people of color continue to be underrepresented in clinical trials. According to FDA data, in 2020, three-quarters of trial participants were white, while only 8% were Black. That same year, 11% of clinical trial participants were Hispanic.

According to the U.S. Census Bureau, 13.6% of the U.S. popu…

Real-world data begin to emerge for the Jynneos vaccine in monkeypox outbreak

[Photo by Artem Podrez from Pexels]

Until recently, CDC had warned that it remained uncertain how effective the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) and the ACAM2000 vaccine from Emergent BioSolutions (NYSE:EBS) were at guarding against the current monkeypox outbreak.

The CDC, however, has begun to release data related to the former vaccine. The agency found unvaccinated patients were approximately 14 times more likely to become infected with the virus based on early real-world effectiveness data.

In the week of August 28, monkeypox incidence was 230 per 100,000 for unvaccinated individuals. Among those who received at least one dose of the Jynneos vaccine in the same period, 15 per 100,000 became infected.

Although the U.S. government has made the ACAM2000 vaccine available for use against monkeypox, it remains unclear how protective it is in the current outbreak.

Because…

FDA Modernization Act to end animal testing requirement passes U.S. Senate

[Image courtesy of Pixabay]

Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent.

Introduced by Senators Dr. Rand Paul (R-KY) and Cory Booker (D-NJ), the bill, if enacted, would curb animal testing in the coming years. A total of 10 other cosponsors backed the bill, which would end the mandate to test new drugs and biosimilars on animals.

The bill was based on S.2952, the FDA Modernization Act of 2021.

“This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods,” said Dr. Paul in a statement. “The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors.”

“Thanks to modern scientific innovat…

FDA approves Amylyx ALS drug Relyvrio

Amylyx Pharmaceuticals (Nasdaq:AML) has won FDA approval for Relyvrio (AMX0035; sodium phenylbutyrate and ursodoxicoltaurine), notching the first win for amyotrophic lateral sclerosis (ALS) in five years.

The drug received Health Canada approval in June. The drug is known as Albrioza in that country.

In a summary, FDA reviewers note that the limited clinical data available for the drug have resulted in “in a degree of residual uncertainty about the evidence of effectiveness” of the drug. The agency notes that the lack of clarity is acceptable given the significant disease burden of ALS.

“This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a news release. “The FDA remains committed to facilitating the development of additional ALS treatments.”

AML shar…