Drug Discovery and Development Archives - Page 97 of 158

Small Pharma Inc. plans Phase 2b trial of DMT for depression

Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD).

DMT is present in Ayahuasca, a South American psychedelic brew.

The company has announced that it has had positive discussions with FDA regarding the planned trial.

“Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase 2b clinical trial, which we anticipate will also be conducted across sites in Europe and the UK,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma. “We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”

The company Small Pharma chose its name as a reaction to the phrase…

EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.”

The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December 13-16.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Dr. Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen, in a press release.

In the U.S., aducanumab has seen several setbacks in recent months.

In August, the Department of Veterans Affairs (VA) decided not to include aducanumab in its drug formulary. The VA…

FDA could soon authorize Pfizer-BioNTech boosters for all adults

The FDA reportedly is planning to authorize the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times.

CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.

A growing number of U.S. states authorized the vaccine boosters for all adults, including California, Colorado, New Mexico, Kansas, Vermont, Kentucky and Maine.

In September, Pfizer asked federal officials to authorize the vaccine booster for all adults. Instead, it received limited authorization for high-risk groups.

To bolster its application for vaccine boosters for all adults, Pfizer included clinical trial data involving 10,000 participants who received a booster dose.

The news comes as U.S. COVID-19 cases have risen 18% in the past 14 days after having fallen steadily…

Atea Pharmaceuticals and Roche end joint development of COVID-19 pill

Atea Pharmaceuticals (NSDQ:AVIR) has announced the termination of a joint venture with Roche involving the development of the COVID-19 antiviral AT-527.

In October, the two companies revealed that the Phase 2 MOONSONG trial focusing on AT-527 did not meet its primary endpoint.

Atea will retain rights to AT-527 after the strategic collaboration with Roche ends on February 10, 2022.

“We believe strongly in the potential of AT-527 with its unique dual mechanism of action, antiviral activity against the major variants of concern and its market potential given the need for additional therapeutic options for COVID-19,” said Jean-Pierre Sommadossi, CEO of Atea Pharmaceuticals, in a press release.

AVIR shares dropped 11.36% in after-hours trading. The shares are down 72.57% so far this year.

Why legacy data management systems can’t support the directions biopharma is headed

Earlier this fall, the FDA detected potential issues in data generated by two contract research organizations (CROs). Specifically, the agency’s statement noted “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.” Accordingly, the agency advised that all affected sponsor organizations repeat any bioequivalence and bioavailability studies essential for approval, and not surprisingly, to do it through organizations other than the two in question or any others with “unresolved data integrity concerns.”

The above anecdote, which is not an isolated occurrence, highlights the importance of data integrity, the lack of which can derail research and set biopharma organizations back by months if not years. My team’s research has found that up to 30% of work is subject to rework because of data issues, wherein the data describing process execution and outcomes simply can’t be located.1 When yo…

Acelyrin raises $250M in Series B funding round

Founded in late 2020, Acelyrin has closed a $250 million Series B financing led by AyurMaya, an affiliated fund of Matrix Capital Management, Surveyor Capital and Westlake Village BioPartners.

Other investors joining the funding round included Cowen Healthcare Investments, Decheng Capital, Marshall Wace, OrbiMed, RTW Investments, LP, Samsara BioCapital, Tybourne Capital Management and venBio Partners.

Acelyrin announced its Series A funding round in December 2020 from Westlake Village BioPartners. The company did not share the size of the fundraising round.

In related news, Los Angeles–based Acelyrin announced that Affibody AB (Stockholm, Sweden) had licensed izokibep, a late-stage IL-17A inhibitor for treating inflammatory diseases.

Izokibep is an interleukin-17A (IL-17A) inhibitor that Acelyrin believes has potential in treating several autoimmune diseases.

Acelyrin is now enrolling patients in an izokibep pivotal trial for treating uveit…

Pfizer to make COVID-19 pill available in low- and middle-income nations

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world.

Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir.

Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to Paxlovid.

MPP’s mission is to expand low- and middle-income countries’ access to vital medicines. The United Nations supports the organization.

Pfizer announced earlier this month that Paxlovid was 89% effective in reducing the risk of hospitalization or death in an interim analysis of the Phase 2/3 EPIC-HR trial.

The collaboration with MPP will enable generic drug makers internationally with sub-licenses to produce Paxlovid for use in 95 countries, which comprise more than half of the world’s population.

“This license is so important because, …

ConcertAI integrates with imaging technology specialist TeraRecon

Privately-held ConcertAI has formally integrated with TeraRecon, a provider of advanced visualization services, including 3D and 4D medical imaging post-processing.

Cambridge, Massachusetts–based ConcertAI says the integration will expand its offerings for life science companies, which now can integrate data from electronic medical records, genomic data and medical imaging. As a result, the company can offer software-as-a-service (SaaS) clinical research and clinical decision support applications.

“TeraRecon solutions are independent of any one manufacturer’s imaging equipment or PACS system, allowing a single, unified, and simplified clinical workflow that can improve efficiencies and deliver actionable physician insights,” said ConcertAI CEO Jeff Elton in a press release. “In the future, the combination with ConcertAI could bring a single, advanced AI-augmented diagnosis and interpretation capability from biomedical innovation throug…

RedHill Biopharma makes progress in RHB-107 COVID-19 study

RedHill Biopharma Ltd. (NSDQ:RDHL) has randomized the last patient in Part A of an ongoing Phase 2/3 study focused on RHB-107 (upamostat), an investigational antiviral.

The Tel Aviv–based company anticipates that RHB-107, a serine protease inhibitor, would be broadly effective against emerging SARS-CoV-2 variants.

RedHill Biopharma expects top-line data for Part A of the trial, which intends to evaluate the safety and tolerability and dose selection, to be available in the first quarter of 2022.

The trial is testing once-daily oral RHB-107 for non-hospitalized patients with symptomatic COVID-19.

By contrast, Merck (NYSE:MRK) and Ridgeback Biotherapeutics tested a twice-daily regimen for the COVID-19 antiviral molnupiravir. The companies tested molnupiravir in patients with mild-to-moderate COVID-19.

“Once again, we see a rise in COVID-19 infections in many countries across the world – and the need for effective, simple and safe oral t…

Emulate debuts second-generation culture module

Boston-based Emulate has introduced the Zoë-CM2 culture module, which prolongs the life of cells within the company’s organ chips. The module can automate the conditions for culturing up to 12 chips.

The culture module is a component of Emulate’s Human Emulation System, which integrates instruments, consumables and software.

Emulate, which is a spinoff from the Wyss Institute for Biologically Inspired Engineering at Harvard University, initially intended to create organ chips to accelerate drug development by replacing animal testing.

The company’s mission has since expanded. “We realized that, essentially, organ chips provide a window on molecular-scale activities inside living human cells within a relevant tissue and organ context,” said Dr. Don Ingber, chair of Emulate’s scientific advisory board, in a recent webinar. Organ chips can yield mechanistic insights for drug discovery in terms of drug action and toxicities. For drug discovery, the technolog…

7 diabetes treatment innovations to look out for on World Diabetes Day

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes.

This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease.

Some of those treatments involve insulin, which was discovered as a treatment for diabetes in 1922 and remains a vital part of the standard of care. World Diabetes Day falls on Nov. 14 because it is the birthday of Frederick Banting, one of the scientists involved in discovering insulin as a treatment for diabetes.

However, while many medtech companies look for ways to make insulin accessible and efficient in treating diabetes, others are innovating treatment avenues outside of insulin. Regardless of the path chosen, all have created intriguing options for managing and treating diabetes. Here are seven innovations in diabetes treatment that are worth keeping an eye on:

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Janssen’s global head of R&D opens up on CAR-T research, data science and beyond

Johnson & Johnson’s Janssen division (NYSE:JNJ) was among the first drug companies to prioritize oncology research.

The company has more than three decades of experience in the domain. Recently, CAR-T therapy has become “one of the most exciting areas of research for cancer and other diseases for the company, said Mathai Mammen, global head of R&D for Janssen, in a recent interview.

In the following Q&A, Mammen provides an overview of the company’s CAR-T research while also touching on its work to revise the treatment of epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). He also touches on new potential indications for Nipocalimab, a fully-human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody, and dishes on the company’s investment in data science in the development of drugs and vaccines.

Drug Discovery & Development: Could you provide a brief overview of Janssen’s work on CAR-T (including ciltacabt…