pharmaphorum

MAY 4, 2022

Moreover, there is the question of the ethics of using animals, numbering in the millions each year, in clinical trials, which sees most euthanized at the end of the process. Once selected, Quris can in-license them, progress them through to phase 1 trials and, those that succeed, can be licensed to pharma companies.

Drugs 143

Drugs Licensing Licensing Pharma Companies 143

Pharmaceutical Technology

MAY 24, 2023

It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

Development 161

Development Production Immune Response Licensing 161

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

pharmaphorum

NOVEMBER 1, 2021

In the ASCEMBL trial , Scemblix achieved a major molecular response (MMR) at 24 weeks in 25% of patients in Ph+ CML in the chronic phase – when the blood and bone marrow contains less than 10% malignant cells – which compared to a 13% MMR with Pfizer’s Bosulif (bosutinib).

Drugs 115

Drugs FDA Approval Trials Containment 115

Druggist

MAY 12, 2021

Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . What is Celevac?

Containment 97

Containment Production Pharmacy Licensing 97

Druggist

DECEMBER 28, 2020

Fexofenadine over the counter will be available as a branded product – Allevia 120mg tablets (each tablet contain 120mg of fexofenadine hydrochloride). Allevia tablets will be licensed as General Sale Item (GSL), which means it will be available over the counter in shops and supermarkets and not only in pharmacies.

Pharmacy 98

Pharmacy Doctors Doctor Allergies 98

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

Vaccine 111

Vaccine Vaccination Immune Response Trials 111

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. chief executive officer of Gamida Cell.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 30, 2021

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Disclaimer. Source link:[link].

Protein 52

Protein Licensing Licensing Containment 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Vaccination Trials Clinical Trials 52

Druggist

FEBRUARY 28, 2021

In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. The licensed use of Circadin is as follows: the short-term treatment of insomnia characterised by the poor quality of sleep in patients aged 55 or over. 1,640 Reviews.

Pharmacy 98

Pharmacy Licensing Licensing Medicine 98

The Pharma Data

OCTOBER 19, 2020

We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.” In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. .

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing Trials 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

JANUARY 3, 2023

SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. The clinical trial participants will be evaluated as part of a long-term study over 15 years.

Gene Therapy 98

Gene Therapy Gene Medicine Trials 98

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Zovirax cream for cold sores is licensed for the treatment of infections caused by Herpes simplex virus presented on lips or face in children and adults. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir.

Containment 98

Containment Pharmacy Sales Drugs 98

Druggist

SEPTEMBER 30, 2020

Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide. Each Colofac or mebeverine tablet contains 135mg of mebeverine hydrochloride. Both products contain the same drug – hyoscine butylbromide.

Pharmacy 98

Pharmacy Containment Drugs Branding 98

The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinical trial of RLY-1971, please visit here.

Licensing 40

Licensing Licensing Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We About INZ-701.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

APRIL 27, 2021

The last few months have seen four occasions in which drugmakers have opted to voluntarily withdraw approvals for cancer drugs that failed confirmatory trials, but this is a rare example of the ODAC convening a meeting to review drugs with a view to potentially voiding their approvals.

Drugs 90

Drugs Trials FDA Approval Marketing 90

The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

Licensing 52

Licensing Licensing Development Production 52

Pfizer

JULY 26, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 27, 2022. Emergency Use Authorization .

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

Licensing 52

Licensing Licensing Marketing Gene Expression 52

Druggist

DECEMBER 2, 2020

Crystacide cream is licensed for the treatment of skin infections caused by a microorganism, which are sensitive to hydrogen peroxide. The other, Golden Eye Ointment is a pharmacy-only medicine which contains dibrompropamidine. CRYSTACIDE CREAM LIPID STABILISED HYDROGEN PEROXIDE 1% W/W - 25 G. £21.99. Buy on Amazon. Price incl.

Bacteria 86

Bacteria Pharmacy Doctors Doctor 86

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based based sites.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

Pfizer

SEPTEMBER 28, 2022

This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group. . Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus .

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

pharmaphorum

DECEMBER 4, 2020

That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

FDA Approval 93

FDA Approval Sales Antibody Drugs 93

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Trials 52

Trials Production Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

Licensing 40

Licensing Licensing Production Development 40

Druggist

DECEMBER 9, 2020

Lotions: contain the least amount of oils and higher amounts of water with non-greasy consistency. Clobetasone has a narrow licensed use. It contains a combination of miconazole (an antifungal drug) and hydrocortisone 1% (steroid). Creams: optimal amount of oil vs water, but in higher oil amounts than lotions. Chickenpox.

Pharmacy 97

Pharmacy Containment Sales Production 97

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

Druggist

DECEMBER 31, 2020

Licensed use and legal status of vibegron (US). The effectiveness of vibegron: summary of clinical trial . Vibegron – licensed use and legal status. 3-adrenoreceptor agonist licensed for the management of overactive bladder. In this post, I will summarise: . It’s a mechanism of action . How does Vibegron work? .

Drugs 59

Drugs Clinical Trials Clinical Trials Licensing 59

Druggist

AUGUST 19, 2020

If appropriate, a recommended 4-week trial with quinine for leg cramps is commenced. In the UK quinine is licensed for leg crams (nocturnal) and treatment of some forms of malaria. Overall the quality of clinical trials was described as low, due to risk of bias in all studies. Can tonic water help with leg cramps?

Containment 69

Containment Production Pharmacy Doctors 69

Druggist

NOVEMBER 6, 2020

The best evidence for or against the effectiveness of medicines comes from well designed clinical trials. Different brands of cough syrups contain very often the same active ingredients. Products containing just guaifenesin are available for self-selection in supermarkets, pharmacies and online. £4.39

Medicine 69

Medicine Containment Production Pharmacy 69

Druggist

OCTOBER 21, 2020

Additionally, oral antifungal tablets are not licensed for use in children. Curanail Once Weekly 5% Fungal Nail Treatment Curanail Once Weekly Fungal Nail treatment contains 5% of amorolfine hydrochloride as an active ingredient. Products which were found inactive in the experiment did not contain any organic acids.

Production 98

Production Containment In-Vitro Sales 98