XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D).

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.

Clinical Trials 200

Clinical Trials Clinical Trials Pharmacy Trials 200

pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Drug Delivery 100

Drug Delivery Drug Delivery Systems Production Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Antibody 100

Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is administered through intravenous drip route.

Antibody 100

Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Antibody 100

Antibody Engineer Development Drugs 100

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer.

Clinical Development 40

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pharmaphorum

MAY 4, 2022

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Quris has taken its technology and used it to develop its own drug candidate pipeline. Organ-on-a-chip.

Drugs 143

Drugs Licensing Licensing Pharma Companies 143

The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development 75

Development Regulation Medicine Containment 75

pharmaphorum

DECEMBER 2, 2021

Along with improved targeting and safety, the capsids are designed to be able to contain larger genes and be easier to manufacture. Astellas effectively created its gene therapy division when it acquired Audentes Therapeutics – which developed AT132 – for $3 billion in 2020.

Gene Therapy 97

Gene Therapy Gene Manufacturing Clinical Trials 97

pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Sansero is focused on developing pharmaceuticals that include a minimal effective dose (MED) of psilocybin in combination with other naturally-sourced ingredients.

Medicine 122

Medicine Life Science FDA Approval Development 122

Pharmaceutical Technology

NOVEMBER 25, 2022

But the challenges for drug producers developing PDFs are numerous and varied. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. Cambrex and its customers currently have multiple clinical and commercial PDF programs underway.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

pharmaphorum

NOVEMBER 9, 2021

After the discussion you will be able to download the white paper – The Answer to Cancer: It’s time we embraced the fact that oncologists are not only making treatment decisions based on clinical data, which is broken down into two- and three-minute reads and contains the research results used to power the webinar’s discussions.

Branding 98

Branding Scientist Marketing Development 98

pharmaphorum

SEPTEMBER 14, 2020

The company has also denied press reports suggesting the patient developed transverse myelitis, an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.

Vaccination 104

Vaccination Vaccine Trials Protein 104

pharmaphorum

APRIL 6, 2022

The ‘ gamification ’ of website design, app development, investment platforms, or just about any activity that exists on the internet, will contain examples of how this strategy maintains user engagement. Due to this, there has been a growth of interest in using this potential for engagement to develop game-based therapeutics.

Development 111

Development Clinical Development Production Trials 111

Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Clinical holds are becoming more common, especially in gene therapy programs.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

FDA Law Blog

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. It is harder to execute full testing programs on lots containing one unit. Lewis, Senior Regulatory Device & Biologics Expert & James E.

Gene Therapy 52

Gene Therapy Gene Production Development 52

The Pharma Data

JANUARY 10, 2021

IDE397 is being developed as a potential best-in-class MAT2A inhibitor for MTAP-deletion, which is prevalent in approximately 15% of all solid tumors. Morgan Healthcare Conference, including preclinical data showing tumor regressions in MTAP-deleted PDX models and proposed Phase 1 clinical plan.

Development 52

Development Clinical Trials Clinical Trials Medicine 52

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “We Programs receiving Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development.

Containment 52

Containment Clinical Development Development Protein 52

The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. SINGAPORE, Oct. SINGAPORE, Oct. The company expects to share further details in early 2021.

Development 40

Development Clinical Development Clinical Trials Clinical Trials 40

XTalks

JUNE 14, 2023

“The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

The Pharma Data

OCTOBER 26, 2020

This work complements the Company’s own development work currently being undertaken. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure.

Development 40

Development Antibody Engineer Production 40

pharmaphorum

SEPTEMBER 9, 2020

It’s a bleak day in the fight against COVID-19, after the UK banned social gatherings of more than six people to contain growing numbers of new cases and the lead vaccine trial from AstraZeneca was halted because of a safety concern.

Vaccination 69

Vaccination Vaccine Trials Containment 69

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within clinical trial communities.

Vaccination 69

Vaccination Vaccine Trials Immune Response 69

The Pharma Data

JANUARY 10, 2021

Food and Drug Administration (FDA) has cleared the initiation of the safety phase of the Company’s EDIT-301 clinical trial, and the Company can begin dosing patients. The Company is required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial.

Medicine 52

Medicine Development Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Synlogic anticipates that subsequent events and developments will cause its views to change.

Clinical Trials 52

Clinical Trials Clinical Trials Containment Clinical Development 52

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

Containment 52

Containment Clinical Development Antibody Development 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

pharmaphorum

SEPTEMBER 8, 2022

Ben Hargreaves examines what advantages radiopharmaceuticals offer in the treatment of cancer and why there has been interest from big pharma in developing these types of therapies. This is why the recent surge in development for radiopharmaceuticals is drawing attention. Aktis has taken a different approach.

Manufacturing 105

Manufacturing Development Antibody Drugs 105

The Pharma Data

JANUARY 13, 2021

NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. SOUTH SAN FRANCISCO, Calif.,

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

The Pharma Data

JANUARY 18, 2021

Potential first-in-class disease-modifying biologic in late-stage clinical studies. Experienced executive development team from Gilead Sciences. ” Vera has executive and clinical development teams with deep experience in drug development and commercialization from Gilead Sciences.

Development 40

Development Life Science Protein Clinical Development 40

The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. See below forU.S. Important Safety Information. Long- term Treatment With Vemlidy in HBV.

Development 52

Development Medicine Clinical Trials Clinical Trials 52

FDA Law Blog

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Regulation 105

Delveinsight

JULY 27, 2021

Cognito Therapeutics located in Cambridge is a clinical-stage company developing novel digital therapeutics that presented clinical data on gamma frequency neuro-modulation on cognitive function from its lead digital therapeutic candidate in AD. However, Seres is not planning on abandoning the treatment for the same.

Vaccination 96

Vaccination Vaccine Trials Manufacturing 96