XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Drug Discovery World

AUGUST 4, 2022

Life sciences property provider Bruntwood SciTech has invested £20 million into redeveloped laboratories at the UK’s North West research campus, Alderley Park. . The new facilities are aimed to help specialist drug companies within oncology, infectious diseases, advanced therapy medicinal products and diagnostics. .

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. Disclaimer.

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XTalks

MARCH 6, 2023

to acquire Mayne Pharma’s US generic prescription products portfolio. The portfolio contains approximately forty-five commercial products, four products in the pipeline, and forty approved non-marketed products, many of which are generics focused on women’s health. Dr. Reddy’s Laboratories Ltd.

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Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. mL strength pre-filled syringe). mL pre-filled syringe.

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Drug Discovery World

AUGUST 9, 2022

Provider to the life sciences industry BioIVT has acquired enzymes manufacturer Cypex in a bid to enhance its product portfolio. . Based in Dundee, Cypex manufactures recombinant xenobiotic metabolizing enzymes with its product portfolio covering a wide range of proteins involved in drug metabolism. . Richard Haigh.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products. The med spa has agreed to this requirement.

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XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

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Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

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XTalks

NOVEMBER 28, 2023

Indicated for the treatment of trichomoniasis in adults, amebiasis in both adults and pediatric patients and anaerobic bacterial infections in adults, Likmez is available as an oral suspension, with each 5 mL containing 500 mg of metronidazole.

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Pharma in Brief

JANUARY 15, 2024

Galderma ), markets two adapalene products in Canada: Differin ® , which contains 0.1% Differin XP TM , which contains a higher concentration of adapalene: 0.3% ( DIFFERIN XP ). There is no need for Board Staff to demonstrate actual market distortion, and no opportunity for a patentee to prove the contrary.

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pharmaphorum

DECEMBER 7, 2021

Since the onset of the Covid-19 pandemic, life science companies have acted quickly to address the evolving digital needs of healthcare professionals, with mixed success (see graph 1). For the most part, life science companies have a relatively good knowledge of what their audiences want and need from them.

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pharmaphorum

MARCH 26, 2021

Medicinal products are mentioned only in passing. This rule applies across all sectors and enshrines the fundamental principle allowing goods that originate in one market to be exported to the other without tax, duty or quota. This applies equally to medicinal products and medical devices as to any other type of goods.

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Pharma in Brief

OCTOBER 20, 2021

A CSP provides patent-like rights and is intended to compensate patentees for a period of patent term lost while innovative pharmaceutical products undergo research and regulatory approval. [1]. The Regulatory Impact Analysis Statement ( RIAS ) calls this the “Timely Submission Requirement”. [2].

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Drug Discovery World

AUGUST 9, 2023

The life sciences sector has seen significant M&A activity over the last few weeks. The news followed an announcement that Biogen would be cutting around 1,000 jobs, or 11% of its workforce, to allow investment into its product pipeline. DDW’s Diana Spencer provides an overview.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan.

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Development Drugs Life Science Marketing 52

Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. Background In January 2022, JAMP Pharma Corporation ( JAMP ) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab).

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XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution.

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Filler FDA Approval Production Marketing 98

pharmaphorum

JANUARY 27, 2021

The plant was visited by Prime Minister Boris Johnson last month along with Wrexham’s conservative MP Sarah Atherton, shortly after the UK government reserved one fill and finish production line at the unit for its exclusive use for 18 months. The contract covers production of 100 million doses of the AZ vaccine.

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XTalks

SEPTEMBER 10, 2020

At the same time, the FDA also issued warning letters to companies who sell or distribute unauthorized e-cigarettes or other electronic nicotine delivery systems (ENDS) products to remove them from the market. The incorporation of appealing flavors and product innovations are some of the factors that have contributed to this increase.

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Drug Discovery World

OCTOBER 19, 2022

Ashley Rein , Global Market Manager for Topical Drug Delivery at Lubrizol Life Science Health (LLS Health), explains how by using mucoadhesive drug delivery, developers can bring novel drugs to market and maximise the efficacy of pre-existing APIs. . Consider drug delivery systems early on .

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Drug Delivery Drugs Drug Delivery Systems Development 52

XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Present and Future Prospects for the Imaging Agents Market In 2021, the market value of imaging agents was reported to be over $9.2 How Does Posluma Work?

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The Pharma Data

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

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XTalks

JANUARY 24, 2022

While some of the bottles contained authentic mediation, others had over-the-counter painkillers or an antipsychotic drug instead of the antivirals. The safety of individuals taking Gilead medication is always our first priority,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in the press release. “We

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The Pharma Data

DECEMBER 17, 2020

Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced that it has signed up the first collaborator in its recently announced Early Access Program for its prototype whole transcriptome panel. TUCSON, Ariz., 18, 2020 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics , Inc.

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Pharma in Brief

JULY 18, 2022

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product.

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The Pharma Data

JANUARY 19, 2021

Over the course of her career, she has held a variety of roles in public affairs, corporate, science and product communications, patient advocacy and marketing at AbbVie, GSK and Schering Plough. The Group must face or might face competition from generic products that might translate into a loss of market share.

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Production Clinical Trials Clinical Trials Containment 52

Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). There are five categories, each containing five cannabis scientists.

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XTalks

JANUARY 9, 2024

Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues. Hyperthyroidism is often treated with medications, radioactive iodine, or surgery to reduce hormone production. percent from 2023 to 2030.

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Pharma in Brief

MARCH 9, 2022

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). markets ACTONEL DR® in Canada for the treatment of osteoporosis. The Court also found that the patent contained sufficient detail to put the invention into practice.

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pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . This large number of e-cigarette users creates a significant market need for vaping cessation therapy. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

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XTalks

APRIL 24, 2023

Dr. Eagleton recently spoke on a webinar with his colleagues from Medpace about lessons learned from successful approaches from rare disease and gene therapy product approvals. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation. How Can Study Protocols Be More Effective?

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Pharma in Brief

JANUARY 24, 2021

The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. In addition, Health Canada also amended regulations to allow for the distribution of samples of over-the-counter drugs and national health product to the public in accordance with CUSMA. (d)

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Pharma in Brief

JANUARY 7, 2024

The stated purpose of the US Importation Rule is “to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety.” Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).

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XTalks

AUGUST 28, 2020

To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. The mask also comes in different colors. So while the Blanc 1.0

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XTalks

DECEMBER 5, 2022

Epidiolex contains sesame seed oil, restricting its use for some individuals. Big pharma continues to eye the medicinal CBD market as it’s currently wide open with high anticipation of growth with new products. Meanwhile, net product sales of Epidiolex grew by 22 percent to $196.2 billion deal in 2021.

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The Pharma Data

MAY 15, 2023

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Nor can there be any guarantee that such products will be commercially successful in the future. Dr. Shamiram R.

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