Drug Discovery and Development Archives - Page 45 of 158

Regular exercise could bolster the efficacy of COVID-19 vaccination

Photo by RF._.studio on Pexels

Recent research published in BMJ found that regular physical exercise appeared to bolster the efficacy of Janssen’s (NYSE:JNJ) Ad26.COV2.S COVID-19 vaccine.

While the vaccine was 60.0% effective against hospitalization in individuals with a low activity level, efficacy climbed to 85.8% for those with a high activity level. Efficacy was 72.1% for individuals in the moderate activity group.

The research defined low activity as less than 60 minutes of at least moderate-intensity weekly exercise. Moderate activity levels ranged between 61 and 149 minutes of such exercise. High activity levels required at least 150 minutes of moderate-intensity exercise.

The study authors defined moderate-level activity based on having an average heart rate between 70% and 79% of maximum.

The study used activity data from wearable devices.

Researchers assessed individual…

Why Numinus is developing psilocybin tea for research

Numinus Wellness (TSE:NUMI) has developed a psilocybin-containing tea bag for clinical research and potentially for clients in psychedelic-assisted therapy.

The Vancouver–based company’s strategy differs from that of other companies that have popped up in recent years with the intent of creating bespoke psychedelic compounds with patent protection. Some companies, for instance, have created deuterated psilocybin analogs with a shortened half-life. Others have synthesized patentable compounds inspired by other classic psychedelics such as DMT or LSD.

Conversely, Numinus and its rival Compass Pathways (Nasdaq:CMPS) intend to provide psilocybin-assisted therapy. While Numinus is using validated strains of Psilocybe cubensis in a tea, Compass Pathways is exploring a synthetic, high-purity polymorphic formulation of psilocybin.

Numinus was the first publicly-traded company to win a license from Health Canada related to psilocybin.

Numinus plans o…

Olympus’ Evident opens new Asia-Pacific HQ

The Evident APAC headquarters. [Image from Evident]

Olympus‘ Evident announced that it opened its new Asia-Pacific headquarters in Singapore as it looks to expand in the APAC region.

In April, Olympus completed the separation of its Scientific Solutions Division into a wholly-owned subsidiary called Evident. The move aimed to provide more room to focus on the continued growth of the company’s Medical Business.

Get the full story at our sister site, MassDevice.

Guselkumab plus golimumab shows promise in Phase 2a ulcerative colitis trial

Janssen’s (NYSE:JNJ) has announced positive data from the first randomized controlled trial to test the safety and efficacy of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumor necrosis factor-alpha (TNFα) antagonist (golimumab) in ulcerative colitis.

In the Phase 2a VEGA study, 48% of patients who received combination induction therapy with guselkumab and golimumab were in clinical remission. By comparison, 31% of patients who received guselkumab alone had reached that state, while 21% of those on golimumab alone did.

Dr. Jan Wehkamp, vice president of Janssen R&D’s gastroenterology disease area, said the company received significant positive feedback on the study at the United European Gastroenterology (UEG) Week conference held earlier this month in Vienna.

The VEGA study provided the first positive data on a combination therapy in immunology, Wehkamp said. Combination therapy is established…

Atai subsidiary wraps up enrollment for clinical study of r-ketamine

Mental health–focused biopharma Atai Life Sciences (Nasdaq:ATAI) recently completed enrollment in a Phase 2a study of PCN-101 (r-ketamine) for treatment-resistant depression.

The company’s Perception Neuroscience division expects top-line results from the trial before the end of 2022.

R-ketamine is an enantiomer of ketamine. Conversely, racemic ketamine is composed of equal amounts of s-ketamine and r-ketamine. We included r-ketamine in our list of emerging antidepressants.

Johnson & Johnson (NYSE:JNJ) has achieved intellectual property protection for S-ketamine and, in 2019, won FDA approval for s-ketamine for treatment-resistant depression.

The company notes that PCN-101 could be a potentially rapid-acting therapeutic for treatment-resistant depression (TRD) that can be administered at home.

[R-ketamine image courtesy of PubChem]

“We anticipate this therapy to be administered i…

4 next-gen CNS drug development trends

Healthy neuron [Image courtesy of NIH]

The past couple of years have had a significant impact on CNS drug development, but it remains difficult to gauge how the field will evolve in the coming years. Many Big Pharma companies have AI initiatives, but most remain at a nascent stage.

The pandemic has exacerbated the mental health crisis, leading to a surge in interest in potentially new treatment options, including psychedelic-inspired molecules. But Big Pharma companies continue to largely sit on the sidelines and let others derisk a class of drugs that have been illegal for decades.

The following article examines a range of topics pertinent to CNS drug development. We touch on the current state of AI adoption and discuss the potential of non-hallucinogenic psychedelic drugs and the future role of connected sensors in CNS clinical trials.

1. Big Pharma will continue to rely on AI partnerships — for …

Pfizer mulls boosting COVID-19 vaccine price to $110 or more per dose

Pfizer (NYSE:PFE) signaled its intent to increase its COVID-19 vaccine price to roughly $110 to $130 per dose after the U.S. government’s purchase program for the vaccine expires, according to Angela Lukin, Pfizer’s global primary care and U.S. president.

The COVID-19 vaccine price hike would pertain to patients 12 and older.

The company could revise the pricing for the vaccine in the first quarter of 2023, assuming the U.S. government transitions COVID-19 vaccination to the private sector by then.

The U.S. government currently pays about $30 per dose for the COVID-19 vaccine from Pfizer and BioNTech (Nasdaq: BNTX).

Pfizer anticipates that private payers would cover the cost of the shots, making them free or nearly so for most individuals.

Demand for COVID-19 vaccines has fallen considerably in 2022, which could compel makers of COVID-19 vaccines to hike prices to meet revenue targets.

Pfizer ultimately anticipates the si…

FDA approves AbbVie’s Rinvoq for nr-axSpA

FDA has approved AbbVie’s Rinvoq (upadacitinib) for adults with active non-radiographic axial spondyloarthritis (nr-axSpA).

The indication covers nr-axSpA patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors.

The JAK1 selective inhibitor Rinvoq now has six U.S. indications.

The new indication makes Rinvoq the only JAK inhibitor approved for adults with nr-axSpA.

To win the latest indication, Abbott submitted data from the Phase 3 SELECT-AXIS 2 clinical study focusing on adults with active nr-axSpA. The placebo-controlled study found that almost half of the recipients of Rinvoq 15 mg had achieved at least 40% improvement based on the Assessment in SpondyloArthritis International Society scale (ASAS40) at week 14. ASAS40 was the primary endpoint.

The safety profile of Rinvoq was similar in the nr-axSpA demographic to earlier Rinvoq trials involving patie…

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…