Pharmaceutical Technology

MAY 24, 2023

The therapy has also received orphan drug and fast-track designations. 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.

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XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide. The approved drugs contain the base form of semaglutide.

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pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Glioblastoma cells have been shown to have receptors to cannabinoids on their cell surface, and lab studies suggest cannabinoid drugs may slow tumour growth.

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Worldwide Clinical Trials

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

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The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 Juyou Bio-Technology Co.,

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. View source version on businesswire.com: [link].

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Druggist

DECEMBER 31, 2020

Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Licensed use and legal status of vibegron (US). Alternative drugs used in the treatment of overactive bladder in the UK . Vibegron – licensed use and legal status. How does Vibegron work? .

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Drugs Clinical Trials Clinical Trials Licensing 59

FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Drug Discovery World

APRIL 11, 2024

The Scottish Medicines Consortium (SMC) has accepted GSK’s dostarlimab as a treatment for adult patients with endometrial cancer when used in combination with platinum-containing chemotherapy. The post GSK’s endometrial cancer therapy approved in Scotland appeared first on Drug Discovery World (DDW).

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Food and Drug Administration or any other health authority. About GDA-201. About Gamida Cell.

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Licensing Licensing Clinical Trials Clinical Trials 52

Druggist

JULY 22, 2020

Promethazine: effect on the body Promethazine belongs to a group of drugs called antihistamines. All products listed above are licensed as pharmacy only medicines – ‘P’ products. How much promethazine is contained in Nigh Nurse liquid? Each 20ml of Nigh Nurse contains 20mg of promethazine.

Nurses 52

Nurses Pharmacy Containment Licensing 52

The Pharma Data

MARCH 30, 2021

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

Protein 52

Protein Licensing Licensing Containment 52

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs. Subsequent-entry products.

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Regulation Drugs Vaccination Vaccine 52

Drug Channels

OCTOBER 11, 2022

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S. contains new data on hospital acquisitions and consolidation activity. The 9 chapters are self-contained and do not need to be read in order. Section 6.1.6.

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Licensing Licensing Containment Drugs 54

pharmaphorum

APRIL 27, 2021

The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab) – across six types of cancer.

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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., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.

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Licensing Licensing Vaccination Vaccine 52

The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. . CAMBRIDGE, Mass., About RLY-1971.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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FDA Law Blog

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. That leaves 60% that manufacture at least one application product.

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Drug Channels

OCTOBER 10, 2023

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S. we summarize the key provisions of the law that relate to prescription drugs. FOUR FUN FACTS The 9 chapters are self-contained and do not need to be read in order.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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World of DTC Marketing

MAY 24, 2022

To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs. Do online mental health apps work? Mental wellness apps are basically the Wild West of therapy.

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Drug Discovery World

MAY 5, 2023

The deal also provides Eterna with an exclusive global license to produce an unlimited number of mRNA-engineered natural killer (NK) and T-cell therapies derived from induced pluripotent stem cells (iPSCs). “We The post Eterna acquires Exacis’ allogeneic immuno-oncology platform appeared first on Drug Discovery World (DDW).

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Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021!

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Licensing Licensing Containment Pharmacy 59

Druggist

NOVEMBER 1, 2020

Lidocaine patch (brand name: Versatis medicated plaster) is a prescription-only medication, which has limited licensed use in the UK. Lidocaine patch offers a different approach to pain management as compared to standard analgesic drugs. The UK licensed use of lidocaine Can you use lidocaine patch for back pain?

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Licensing Licensing Containment Medicine 59

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Drug Discovery World

JULY 3, 2023

PrecisionLife and the University of Oxford have signed a data access agreement to license the Oxford Endometriosis Gene (OXEGENE) dataset to develop new personalised treatments for endometriosis patients. The post Endometriosis partners to discover personalised treatments appeared first on Drug Discovery World (DDW).

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Genetics Genotype Medicine Licensing 52

The Pharma Data

AUGUST 17, 2020

Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. 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.

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FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. By Serra J. See our previous coverage of such state laws here , here and here.)

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Pharmacy Checkers

SEPTEMBER 20, 2019

A lot of media coverage about counterfeit drug threats in the U.S. with counterfeit drug sales and other forms of drug sales, ones that clearly harm patients. with counterfeit drug sales and other forms of drug sales, ones that clearly harm patients. The Kaiser story, written by John M.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.

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Druggist

SEPTEMBER 30, 2020

Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs.

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Druggist

JANUARY 9, 2021

Migraine management with drugs in broadly divided into prophylactic treatment (to prevent migraines) and acute treatment for managing migraine-associated headaches and nausea. This post will focus on the acute management of migraines with drugs, which can be purchased over the pharmacy counter. Paracetamol.

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Containment Pharmacy Production Drugs 98

Druggist

AUGUST 3, 2020

Otrivine Extra Dual Relief is a pharmacy only medication and the only over the counter product containing ipratropium bromide for the management of congestion and runny nose caused by colds. Sale restrictions are related to indicated use of the product reflected by its license. Do you take any medicines?

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Druggist

DECEMBER 28, 2020

Fexofenadine belongs to a group of drugs called antihistamines. Fexofenadine over the counter will be available as a branded product – Allevia 120mg tablets (each tablet contain 120mg of fexofenadine hydrochloride). The decision to make fexofenadine available without a prescription is based on the safety profile of this drug.

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