STAT News

APRIL 24, 2023

Until this point, no licensed vaccines or treatments are available for Marburg. Currently, Equatorial Guinea and Tanzania are experiencing their very first Marburg outbreaks , and non-pharmaceutical control measures have so far struggled to contain this deadly hemorrhagic filovirus with a mortality rate of more than 50%.

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Pharmaceutical Technology

MAY 25, 2023

Adalvo has entered a strategic licensing agreement with Swiss pharmaceutical company EQL Pharma for Mellozzan (melatonin) outside Europe and the US. Mellozzan contains the sleep hormone melatonin and is indicated for use in children with attention deficit hyperactivity disorder (ADHD) and sleep difficulties.

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Pharmaceutical Technology

MAY 25, 2023

The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. The trial, conducted in 1,800 healthy individuals ranging from ages 2-29 years in Mali and The Gambia in 2021, found NmCV-5 induced a strong immune response across five strains of meningococcal bacteria.

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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

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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.

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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].

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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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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. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). Under the collaboration, Genentech will assume development of RLY-1971 with the potential to expand into multiple combination studies including with Genentech’s investigational inhibitor of KRAS G12C, GDC-6036. About RLY-1971.

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FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

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Druggist

JULY 22, 2020

All products listed above are licensed as pharmacy only medicines – ‘P’ products. The active ingredients contained in Night Nurse product include: dextromethorphan hydrobromide paracetamol promethazine hydrochloride Night Nurse is licensed for symptomatic management of cold and flu symptoms at night.

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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). The approved drugs contain the base form of semaglutide. Instead, they may contain compounded semaglutide in salt forms, which could pose health risks.

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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 programme was licensed from Bayer Healthcare and is a fifth generation neutrophil elastase inhibitor (NEI) targeting the inflammatory aspects of AATD, a rare condition.

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Worldwide Clinical Trials

FEBRUARY 21, 2024

Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations.

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Drug Channels

OCTOBER 11, 2022

This 2022-23 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. contains new data on hospital acquisitions and consolidation activity. pharmaceutical distribution industry.

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The Pharma Data

AUGUST 17, 2020

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the definitive agreement with Dragonfly (the “Definitive Agreement”).

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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. This means that dostarlimab is the first immunotherapy treatment to be accepted for use within NHS Scotland for this group of eligible patients.

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pharmaphorum

MAY 4, 2022

There are existing alternatives, with one being human cell culture systems, which provide an environment that is closer to that which will eventually receive treatment but do not contain the complexity of a complete organism. Organ-on-a-chip. Nascent technology.

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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.

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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 We are excited to bring this powerful platform into Eterna.

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Drug Discovery World

AUGUST 25, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. The top stories: Could GLP-1 receptor agonists treat addiction and dementia?

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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., All forward-looking information contained in this press release is qualified by this cautionary statement. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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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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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Sosei Group Forward-looking statements.

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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?

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Druggist

NOVEMBER 1, 2020

Lidocaine patch (brand name: Versatis medicated plaster) is a prescription-only medication, which has limited licensed use in the UK. The UK licensed use of lidocaine Can you use lidocaine patch for back pain? As the name suggests, lidocaine patch is a medicated plaster which contains a local anaesthetic – lidocaine 5%.

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XTalks

JULY 10, 2023

One significant controversy centered around the “Super Creatine” label on Bang Energy drinks, which Monster argued was deceptive, given the drinks contained no actual creatine. A jury ruled in Monster’s favor, holding that Bang Energy drinks did not contain any actual creatine.

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Drug Channels

OCTOBER 5, 2021

This 2021-22 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. The 9 chapters are self-contained and do not need to be read in order. pharmaceutical distribution industry.

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Drug Channels

OCTOBER 10, 2023

No other report on the market today offers the depth, insight and analysis into these channels This 2023-24 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson.

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World of DTC Marketing

MAY 24, 2022

DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. The problems at Cerebral as Business Insider reported that the Drug Enforcement Agency (DEA) is investigating the company.

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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. Endometriosis affects 10% of women globally, but on average it takes over seven years for patients to receive a diagnosis.

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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.

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FDA Law Blog

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” FDA borrowed this definition from 21 C.F.R. But in 2020, a Citizen Petition came along looking to upend FDA’s approach to strength.

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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FDA Law Blog

JULY 18, 2023

Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). That leaves 60% that manufacture at least one application product. The PHE also had a dramatic effect on import alerts.

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Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. BA HCP ISI 09JUL2020.

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