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

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. Antares Pharma’s injectables are available in disposable multi-dose pen injectors and unit dose containers. It caters its subcutaneous injection technology platforms to both generic and branded injectables.

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. Its Plamotamab is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3).

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. Its Plamotamab is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3).

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. Its Plamotamab is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3).

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. About Sandoz.

Clinical Development 40

Clinical Development Medicine Development Production 40

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

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. An organoid system approach takes self-organising clusters of cells that grow in three dimensions, closely resembling real tissue and organs.

Drugs 143

Drugs Licensing Licensing Pharma Companies 143

pharmaphorum

SEPTEMBER 14, 2020

It uses a weakened, non-replicating, version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 coronavirus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Vaccine 104

Vaccine Vaccination Trials Protein 104

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. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

Medicine 122

Medicine Life Science FDA Approval Development 122

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

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

Pfizer

AUGUST 3, 2022

We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

Development 101

Development Vaccine Vaccination Production 101

The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

Containment 52

Containment Clinical Development Development Protein 52

Worldwide Clinical Trials

JUNE 15, 2022

It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012. Most of this pipeline focuses on oncology and rare disease investigational therapeutics, and most, unsurprisingly, are in the earlier phases of development. The cell and gene therapy pipeline is booming.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

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

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. Clinical development is no game.

Development 111

Development Clinical Development Production Trials 111

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.

Vaccine 69

Vaccine Vaccination Trials Containment 69

pharmaphorum

SEPTEMBER 1, 2020

The vaccine is still the frontrunner in a list of 30 COVID-19 vaccines in clinical development maintained by the World Health Organization. The virus contains genetic material of the SARS-CoV-2 spike protein, priming the immune system to attack the SARS-CoV-2 coronavirus if it later infects the body.

Vaccine 69

Vaccine Vaccination Trials Immune Response 69

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

Containment 52

Containment Clinical Development Antibody Development 52

FDA Law Blog

DECEMBER 15, 2024

It is harder to execute full testing programs on lots containing one unit. Key takeaway for CMC: What makes a successful CMC section for an IND or BLA looks very different for every development program. As a result, how you approach your PPQ will be drastically different.

Gene Therapy 52

Gene Therapy Gene Production Development 52

XTalks

JUNE 14, 2023

percent is an immunosuppressant in the class of calcineurin inhibitors, specifically developed for treating the signs and symptoms associated with dry eye disease. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. Vevye (cyclosporine ophthalmic solution) 0.1

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

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. About Moderna. Moderna has been named a top biopharmaceutical employer by Science for the past five years.

Vaccine 52

Vaccine Vaccination Manufacturing Clinical Development 52

XTalks

DECEMBER 5, 2023

Augtyro, a tyrosine kinase inhibitor (TKI), is available as oral capsules, each containing 40 mg of repotrectinib. The encouraging results also suggest that further clinical development of unecritinib is justified, particularly for NSCLC cases involving ALK rearrangements.

Protein 115

Protein FDA Approval Medicine Trials 115

The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Source: Harpoon Therapeutics .

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

XTalks

APRIL 24, 2023

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. Early and ongoing engagement with regulators greatly helps clinical development planning.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

NOVEMBER 12, 2020

Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical development, to advance its late-stage research programs and for working capital and general corporate purposes.

Containment 40

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Pharmaceutical Technology

NOVEMBER 25, 2022

In many cases, pharma companies select a contract development and manufacturing organisation (CDMO) to develop products versus doing the work themselves for reasons related to cost, convenience, and capacity. In one specific case, Cambrex developed a PDF containing two APIs in suspension in an 80/20 ratio.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

pharmaphorum

MARCH 29, 2022

We designed BIIB078 to test the prevailing hypothesis that the mechanisms of disease for C9orf72-associated ALS were caused by toxicity associated with the repeat containing RNA and corresponding dipeptides,” said C. Frank Bennett, executive vice president, chief scientific officer and franchise leader for neurological programs at Ionis.

Trials 49

Trials RNA Containment Genetics 49

The Pharma Data

JANUARY 4, 2021

In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. For more information, please visit www.polyphor.com.

Bacteria 52

Bacteria Development Containment Protein 52

The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

Clinical Development 52

Clinical Development Sales Development Containment 52

The Pharma Data

OCTOBER 21, 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.

Engineer 40

Engineer Containment Medicine Clinical Trials 40

Pfizer

FEBRUARY 16, 2023

While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

pharmaphorum

OCTOBER 30, 2019

Pathways have not held up to their promise for containing cost. For example, PD-1/PDL-1 drugs have shown conflicting outcomes associated with receptor expression – and these drugs are the backbone for many combo regimen programs in clinical development. However, there are limitations in the breadth and utility of these tools.

Drugs 40

Drugs Containment Clinical Development Manufacturing 40

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. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Regulation 105

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

Drugs 52

Drugs Containment Development Clinical Development 52