Pharmaceutical – Page 3 – Swanson Reed | Specialist R&D Tax Advisors

Tonix Pharmaceuticals to Open R&D Center in Maryland

Tonix Pharmaceuticals, a pharmaceutical company focused on developing repurposed drugs for central nervous system (CNS) conditions, has announced their plans to acquire an R&D facility in Frederick, Maryland.

The 48,000 sqft R&D facility will expand their vaccine and treatment development capabilities, with initial focus on COVID-19. They have currently started development of three treatment options, adn are looking to speed up the development process. An additional vaccine in development would protect against smallpox and monkeypox.

As the Delta variant leads to a rising case count in both the US and the UK, development of additional or new vaccines and treatments is paramount. But COVID-19 isn’t the only concern in the states. The re-emergence of monkeypox has been noted with cases in the US, Israel, Africa, and the UK. Tonix Pharmaceuticals aims to use their R&D facility to create a rapid and effective vaccine pipeline with efficacious results to get ahead of potential spreading diseases.

“The Fredrick facility will be a major expansion of our R&D capabilities,” Tonix CEO Dr. Seth Lederman said in a statement. “We believe this facility will ensure adequate resources and capacity to support and grow our pipeline of vaccines and antiviral therapeutics. In addition, we view control of in-house facilities as a strategic capability to ensure the speed and efficiency with which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens.”

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

BeyondSpring to Host R&D Day for Plinabulin

BeyondSpring Inc. is a global leader in biopharmaceuticals with focus on cancer therapies. They have recently announced their plans to host an R&D Day to discuss the development program for their novel immune agent – Plinabulin.

The R&D day will take place in late June with presentations from experts in the field who will highlight the unmet medical needs in treating patients with non-small cell lung cancer (NSCLC).

They will also discuss their pipeline as it applies to their lead asset plinabulin – a selective immunomodulating microtubule-binding agent (SIMBA). Their focus will specificall be on:

Plinabulin and G-CSF combination, which received priority review by the U.S. Food and Drug Administration (FDA) for its NDA for prevention of chemotherapy-induced neutropenia (CIN), which also received breakthrough designation. The Company has a PDUFA date of November 30, 2021.
Plinabulin and docetaxel combination, which is in a fully enrolled pivotal Phase 3 global study (DUBLIN-3) as a potential direct anticancer agent in patients with NSCLC. DUBLIN-3 is expected to report data in mid-2021.
Plinabulin in combination immune-oncology regimens, leveraging its MOA as a potent APC (antigen presenting cell) inducer. Plinabulin has demonstrated promising Phase 1 data in 2nd/3rd line SCLC (ASCO 2021); company has recently initiated a Phase 1 study in 7 cancers which failed checkpoint inhibitors to investigate plinabulin’s potential to reverse resistance to immunotherapy.

Are you developing new pharmaceuticals for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

MannKind and United Therapeutics Earn FDA Priority Review Status

New Jersey Patent of the Month - May 2021

The FDA has granted priority review status for Tyvaso DPI as it seeks approval. Tyvaso DPI is a dry powder inhaled formulation of treprostinil to treat pulmonary arterial hypertension (PAH) as well as pulmonary hypertension associated with the interstitial lung disease (PH-ILD).

This priority review process shortens the FDA review period to eight months rather than an entire year.

United Therapeutics developed Tyvaso DPI and submitted the new drug application and request for priority review in April. MannKind Corp. developed the handheld Dreamboat inhalation device used to deliver Tyvaso DPI.

This collaboration works to deliver Tyvaso DPI to patients so that the drug may lower blood pressure and improve patient health. Over the course of initial Phase 1 trials, patients showed improvement in their ability to perform exercise and reduced PAH symptoms overall.

In anticipation of transitioning from manufacturing Dreamboats for a small clinical supply to a larger prelaunch inventory, MannKind is scaling up its R&D facility in Danbury, Connecticut.

“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere technology,” said Joe Kocinsky, MannKind’s chief technology officer. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Revive Therapeutics Teams Up with UHSA in Psychedelics

Pennsylvania Patent of the Month - May 2021

Revive Therapeutics Ltd. has announced their agreement with the University of Health Sciences Antigua to collaborate on taking Revive’s novel psychedelic-assisted therapies into clinical research.

Revive Therapeutics has been conducting research at the University of Wisconsin-Madison focused on psychedelic therapeutics. They initially focused on therapeutics for infectious diseases and rare disorders and the development of FDA approved drugs. Their interest in psilocybin-based therapeutics applies to a range of diseases and disorders combined with their novel and patented drug delivery methods could allow delivery of psychedelics in an oral thin film patch and topical forms.

This collaboration will focus on:

Development of a psychedelic treatment center using Revive’s novel formulations and delivery forms of psychedelics, including its proprietary psilocybin oral-thin film product to treat mental health and substance abuse disorders
Conduct clinical studies to support regulatory drug approvals in the Caribbean dn to accelerate US FDA clinical developments
Establish a Master’s in Psychedelic Medicine to allow students the opportunity to expand their knowledge of the field

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

InVivo Biosystems to Aid in Anti-Ageing

Oregon-based InVivo Biosystems works to develop the technology to drive insights and decisions in biomedical research. Through the use of non-mammalian model organisms, they provide better understanding of results within pharmaceutical, nutraceutical, and biotech research. Recently, they have announced the launch of their new InVivo Longevity Platform which can analyze the effects of compounds on factors like lifespan, healthspan and transcriptional changes.

Their platform will aid anti-ageing product R&D. They continue to use non-vertebrate models and have worked with hundreds of clients in recent months to test their platform functionality. The platform helps firms assess the performance of their products by generating concrete efficacy data. It makes it easier to ensure accuracy, reproducibility, and robust conclusions by combining continuous automated data collection of lifespan metrics and genetic analysis. This rapid analysis can speed up assessment and product production, completing a project within five months. This speed and accuracy gives companies a greater opportunity to focus on products and formulations that have a real chance at success, rather than committing years to a product with no concrete evidence to support it.

InVivo’s platform will provide a way to address the product validation needs of the age-tech and longevity industry. Through analysis, it can inform product development teams on the impact of their compound on lifespan, activity level, and muscle use throughout senescence, and the underlying Mechanism of Action. Many clients rely on the service to help them find the best formulations and to substantiate product claims with real data.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Goodness Growth to Enter Psychedelic Research

Following success in cannabis research, Minnesota-based Goodness Growth Inc. has announced their plans to enter the psychedelics world. They intend to initiate clinical research into plant-based psychedelic medicine. This research will be conducted by their subsidiary, Resurgent Biosciences.

Resurgent Biosciences is a non-plant touching entity, which focuses on developing naturally-derived medicines, therapies, products, and technologies for use in health, wellness, and recreation. Psychedelics have been an increasingly popular topic of research, as their benefits are being uncovered in areas like mental health and anxiety treatment. Recent studies have been published highlighting the efficacy of psilocybin as a treatment for depression.

“I wanted to wait for a kind of threshold of evidence to make sure this was a real opportunity, and that it would be real medicine for people ” said Dr. Kyle Kingsley, CEO of Goodness Growth. “It’s gone beyond that. It’s really sort of exceeded my expectations as far as the therapeutic potential of psychedelics.”

Following these research advancements, Goodness Growth decided to join the game and begin contributing to this clinical research. They intend to partner with other like-minded businesses to begin expanding this research body before moving into commercialization. They believe psychedelics will significantly alter the landscape for treatment of psychiatric disorders in the same way cannabis altered treatment of chronic pain.

Are you developing new technology for a new application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Local Medicinal Manufacturing can Speed Up Clinical Trials

Snapdragon Chemistry is a leader in flow chemistry and process development. They work to find solutions to harness significant advantages of continuous flow technology and autonomous reaction platforms. These solutions can be used to enhance the discovery, development and manufacturing value chain.

This past year showed many weaknesses in the manufacturing of medicines for clinical trials. Many of these medicines rely on international partners to meet certain steps of the pipeline. Snapdragon Chemistry saw these limitations and decided it’s time to revamp the processes involved. They have since been developing methods for local manufacturing. This solution brings reliability and resilience to the industry as well as reduces the time needed to bring new medicine to patients.

Their focus is on developing the technologies needed to speed up the clinical trials processes through local manufacturing. In order to achieve this, they have begun development of a 51,000 sq ft facility in Massachusetts. This facility will offer space to produce specialty chemicals for use in medicinal formulations in house. With the use of their automated technologies, Snapdragon believes their innovation will only pick up speed.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Mydecine has Breakthrough Discovery in Medicinal Mushrooms

Mydecine Innovations Group Inc. has announced a groundbreaking discovery in their psilocybin research. Mydecine is an emerging biotech and life sciences company focused on developing solutions for a range of mental health problems. They operate in Canada as well as in their mycology lab in Denver, CO. This lab focuses on the genetic research and scaling cultivation of rare medicinal mushrooms. Their groundbreaking discovery showed over 40 compounds with pharmacological potential in these mushrooms.

This discovery came after screening over 25 mushroom species. These 40 unique compounds have been found throughout the various species. Most of these compounds have never been reported before. Mydecine believes they could be vital to the critical effects of naturally sourced mushrooms and their beneficial effects on human health. Most compounds within a mushroom have been evolved to protect the mushroom and affect biological systems and aspects of metabolic pathways. This is a great indication of their pharmacological indications.

Mydecine is hopeful that at least some of these mushrooms will contribute to psychedelic-assisted therapy and will continue to research and formulate potential drug candidates.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

US Lawmakers Hope to Bring Back Life to Covid-Disrupted Clinical Trials

The pandemic has brought about crazy innovation levels as pharmaceutical companies fought to develop coronavirus vaccines and treatments at record speeds. Unfortunately, that also means that active clinical trials were halted or cancelled entirely. Patients enrolled in or awaiting clinical trials for treatment have been left on hold, unsure if they should continue waiting for the experimental treatments or move forward with existing (if any) treatments. But as we slowly begin to move towards recovery from the pandemic, it’s time to help those halted clinical trials and get other areas of health science research back on their feet. Or, atleast, that’s what two lawmakers are proposing.

Bobby Rush and Brian Fitzpatrick have proposed the LOANS for Biomedical Research Act, a bipartisan bill, that would provide funding in the form of BioBonds to companies and universities conducting FDA-approved clinical trials to identify therapies for unmet medical needs.

If successful, up to $10 million of BioBonds would be issued through 2022 to 2024. This funding is not a grant – it is a loan and needs to be paid back regardless of trial success. This caveat means the researchers who receive it would need to have long-term, risk-averse capital which is not really what we see in the pharmaceutical industry.

This past year has shown us that when funded well, drug research can be sped up. When given resources, and trials are not slowed down by years of gathering funding and supplies, the results could be astounding. With any luck this bill could provide an opportunity to really advance R&D in the pharmaceutical and healthcare world.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.