FDA Law Blog

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. OPQ attributes that in part to the decrease in the use of injectable products as the PHE waned.

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The Pharma Data

NOVEMBER 4, 2020

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

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FDA Law Blog

SEPTEMBER 7, 2022

Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. Product Quality Defect Reports.

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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 companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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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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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.

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The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. . .

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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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. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

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Druggist

MAY 12, 2021

In this post, I will briefly review the use of Celevac,:what it is and talk about alternative options (prescription and over the counter products) which have similar use to Celevac. Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. What is Celevac?

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Roots Analysis

JUNE 6, 2024

Autoinjectors Market Manufacturers & Current Landscape Presently, close to 150 autoinjectors have been commercialized / being developed by more than 50 players for the treatment of various therapeutic areas, including diabetes, multiple sclerosis and rheumatoid arthritis.

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pharmaphorum

JANUARY 20, 2022

The Swiss subsidiary of Glenmark Pharmaceuticals and Lotus International have signed a licensing agreement whereby Glenmark will handle the manufacture and supply of Ryaltris and Lotus will take charge of commercialising the drug, subject to approval. with allergic rhinitis.

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The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure . generic version of the product. These are challenges not only for ViiV Healthcare but also for any future generic licensees. About ViiV Healthcare.

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Druggist

DECEMBER 28, 2020

The Government recently announced the reclassification of fexofenadine 120mg, which will be available as General sale Medication (GSL), sold as branded products – Allevia 120mg tablets. Fexofenadine over the counter – the first GSL product. Fexofenadine over the counter – the first GSL product.

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The Pharma Data

AUGUST 17, 2020

. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002.

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XTalks

DECEMBER 20, 2021

It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan. It contains Novavax’s Matrix-M adjuvant to enhance the immune response. Novavax has said it should be able to manufacture 2 billion doses per year beginning in 2022.

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Pfizer

APRIL 26, 2023

Our engineers created specially designed, temperature-controlled shipping containers (that we call “shippers”), which contain GPS temperature enabled trackers for continuous, real-time location and temperature monitoring and can maintain required temperature conditions for up to 10 days unopened. In the U.S.,

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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. Vlad Coric , M.D.,

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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., About Otsuka Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.”

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The Pharma Data

MAY 15, 2021

Product Name: Ceracare. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Thousands of people enjoy. Actor portrayal.

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The Pharma Data

MAY 14, 2021

Product Name: Unity. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Unity is 100% natural, safe and effective. Actor portrayal.

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Drug Discovery World

FEBRUARY 1, 2023

But for this market to become a reality, we need much more research into cannabis products and potential indications. There are more than 1300 clinical trials on cannabis underway and companies focused on the cultivation and manufacturing of cannabis are also educating doctors and patients about its potential pharmaceutical use.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. We also market or plan to market in China additional oncology products licensed from Amgen Inc.,

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pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 This is an important capability because radiopharmaceuticals require just-in-time manufacture and delivery each week. The copper pairing provides significant supply and manufacturing advantages. Different methods.

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Find Me Cure

SEPTEMBER 21, 2021

Many older homes still contain asbestos, putting residents at risk. This means there may be legacy asbestos in older products, buildings, and homes. If your home was built before the 1980s, it may contain asbestos materials. Depending on where you live, they may be state-licensed or federally-licensed.

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pharmaphorum

MARCH 26, 2021

Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. Even where products do originate in the UK or EU, thus qualifying for tax and duty-free status, this does not mean they can cross the border without friction.

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Pharma in Brief

APRIL 13, 2021

Health Canada has also published a guidance document that contains additional information for drug sponsors. As in the IO, the FDR amendments permit the Minister to impose terms and conditions on a DIN where the manufacturer has relied on certain flexible safety and efficacy requirements available for an NDS under the amendments.

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The Pharma Data

DECEMBER 22, 2020

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs. The approval and commercial success of the product may not be achieved.

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com. AUTHORIZED USE The U.S.

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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.

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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.

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The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. About Y-mAbs. Forward-Looking Statements.

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The Pharma Data

JULY 27, 2021

About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans.

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Druggist

APRIL 3, 2021

Codeine containing products , such as co-codamol , may not be the best choice since codeine can cause constipation, possibly aggravating the condition. Contains glyceryl trinitrate (GTN). Very often, unlicensed medicines are ordered from suppliers, which make and redistribute unlicensed products. References.

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The Pharma Data

NOVEMBER 2, 2020

OTC PINK:DECN) www.decisiondiagnostics.co , a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., added to their Amazon professional use product offerings,” said CEO Keith Berman. million diabetics worldwide.

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The Pharma Data

APRIL 27, 2021

COMIRNATY® will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied. The information contained in this release is as of April 19, 2021. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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Pharmaceutical Technology

MAY 15, 2023

Pyridine derivatives contain one nitrogen atom in a six-membered aromatic ring and are the most extensively used heterocycles in the field of drug design, due to their promising effect on pharmacological activity, which has led to the discovery of numerous broad-spectrum therapeutic agents.

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