Pharma Mirror

APRIL 18, 2023

Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Pharmaceutical Technology

JULY 28, 2022

Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

MARCH 10, 2023

Sandoz, a division of Novartis , has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.

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Pharmaceutical Technology

MARCH 24, 2023

Moderna has entered a strategic partnership with Generation Bio for the development of non-viral genetic medicines. Moderna’s biological and technical expertise will be combined with core technologies of the non-viral genetic medicine platform from Generation Bio.

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Pharma Mirror

APRIL 13, 2021

Wolff”) and the Spanish pharmaceutical company Cantabria Labs (“Cantabria Labs”) concluded a strategic partnership on March 12th 2021 by entering into an exclusive licensing agreement for a newly developed medicinal product for the treatment of hyperhidrosis.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. We look forward to utilising our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China. “We

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Drug Patent Watch

OCTOBER 12, 2021

Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. This paper was originally published by Md.

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Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.

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XTalks

DECEMBER 4, 2024

Conventional resveratrol products often face challenges like poor absorption and significant gastrointestinal side effects. In the Asia-Pacific market, Jupiter has negotiated partnerships with companies such as Sichuan Kelun and Tianjin Pharmaceuticals, focusing on Jotrol’s integration into traditional Chinese medicine frameworks.

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Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease.

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Pharmaceutical Technology

AUGUST 12, 2022

Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction. Following the introduction of customs controls in January 2021, medicine imports from the EU fell to their lowest levels in years. Changes to batch testing requirements.

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Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Most codeine products are combination products of codeine and another drug. Restrictions on the supply of codeine-containing products. Codeine over the counter: UK list of products. Prescription-only codeine.

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Druggist

NOVEMBER 10, 2020

Today I will list Calpol alternative products, including other brands and forms of liquid paracetamol and alternative drugs. Although the intention is to find Calpol alternative products for toddlers and children, I included a few products, which have a minimum age restriction of 12 years and above. Calpol alternative products.

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Pharmaceutical Technology

JUNE 19, 2023

Oral liquid medicine manufacturer Rosemont Pharmaceuticals has announced the acquisition of Lucis Pharma. UK-based Rosemont hopes that this latest acquisition will bolster its portfolio with a pipeline of innovative products and allow it to serve the UK and overseas markets.

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STAT News

OCTOBER 20, 2022

Three dozen institutional investors are urging the boards at several of the world’s largest pharmaceutical companies to establish concrete metrics for linking executive compensation with policies that widen access to medicines to low- and middle-income countries.

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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. In October, the U.S.

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Pharmaceutical Technology

MAY 2, 2023

As per the agreement, BMS could exercise opt-in rights for any of the four TCR-T product candidates being developed by Immatics. This news comes a few weeks after BMS signaled an increased focus on cell therapy manufacturing with a takeover of former Novartis plant to boost viral vector production for T-cell therapies.

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pharmaphorum

MARCH 24, 2022

There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. The platform uses an artificial intelligence (AI) algorithm to zero in on the genes encoding natural products based on their computationally predicted human target.

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BioPharma Reporter

DECEMBER 7, 2023

Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a Â1 million investment.

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Pharmaceutical Technology

DECEMBER 9, 2022

Brazilian public spending on healthcare, drug pricing reforms and remote medicine. Advantages of joining PIC/S include the adoption of codes that should reduce the number of audits required for some products, accelerating their time to market. Enabling Access to Medicines: What Manufacturers and Patients Need to Know. <p>Early

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Scienmag

JANUARY 12, 2022

E-cigarettes are currently regulated as consumer products so cannot be promoted as smoking cessation aids, he explains. Nicholas Hopkinson at Imperial College London welcomes the move, saying this will give doctors another means to help smokers quit.

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Outsourcing Pharma

JANUARY 29, 2024

The Pistoia Alliance has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license.

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Scienmag

DECEMBER 14, 2021

Epileptic seizure frequency fell by an average of 86% among 10 children treated with whole plant medicinal cannabis, reveals a case series, published in the open access journal BMJ Paediatrics Open. None of the children had responded to other treatments, including the only cannabidiol (CBD) product licensed for their condition.

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Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The CHMP evaluates the product’s quality, safety, and efficacy and provides an opinion to the European Commission (EC).

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Pharmaceutical Technology

JANUARY 4, 2023

Gilead Sciences has entered a collaboration and licensing agreement with EVOQ Therapeutics to advance the latter’s technology and develop immunotherapies to treat rheumatoid arthritis (RA) and lupus. The company will also receive tiered royalties on sales of the product.

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Scienmag

MARCH 28, 2021

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. March 29, 2021) – The U.S.

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Druggist

NOVEMBER 6, 2020

Chesty cough, also known as a productive cough, is characterised by overproduction of mucus. Patients commonly request over the counter medicines for a chesty cough. In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK.

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Pharmaceutical Technology

MAY 8, 2023

Under the terms of the license and commercialisation deal, Dr. Reddy’s will get licence for the development and commercialisation of toripalimab in India, Panama, Peru, Colombia, South Africa, Brazil, Argentina, Chile, Uruguay, and Mexico. Junshi Biosciences may get an aggregate of up to $728.3m

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XTalks

DECEMBER 18, 2024

The most common form of CAH, 21-hydroxylase deficiency, disrupts hormone production, leading to cortisol deficiency and an overproduction of androgens. Trial data for both the pediatric and adult trials were published in The New England Journal of Medicine. Crenessity marks the third approved drug for Neurocrine.

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Fossil Remedies

OCTOBER 16, 2022

To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. The next important thing is the license. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. License required to start a Pharmaceutical Business in India.

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pharmaphorum

FEBRUARY 3, 2022

While the regulatory framework for cannabinoid products remains fragmented and hard to navigate around the world, Germany has emerged as an early-mover. Germany also proposed last year that it would allow “controlled sale” of cannabis in licensed shops, including for recreational purposes.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Pharmaceutical Technology

FEBRUARY 17, 2023

It will use the machine learning platform from Zephyr AI and a real-world data set (RWD) from M2GEN for creating an oncology discovery product. Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services.

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).

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Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). The company will also be eligible for tiered royalties as a percentage of global commercial sales of the products.

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Pharmaceutical Technology

NOVEMBER 1, 2022

The European Commission (EC) has granted orphan medicinal product designation for Karyopharm Therapeutics and the Menarini Group’s Nexpovio (selinexor) to treat myelofibrosis (MF). The companies signed an exclusive licensing agreement in December 2021. The therapy is commercialised in the US as Xpovio.

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