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). The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.

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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

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. Pfizer Disclosure Notice.

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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). Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges. The approved drugs contain the base form of semaglutide.

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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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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

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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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. CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination.

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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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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. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.

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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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The Pharma Data

AUGUST 17, 2020

Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. In addition, Dragonfly will receive up to 24% royalties on worldwide net sales.

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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 .

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Medicine Licensing Licensing Manufacturing 52

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. . To help with diarrhoea.

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Containment Production Pharmacy Licensing 97

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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Licensing Licensing Containment Pharmacy 63

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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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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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.

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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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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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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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Pharmacy Doctors Doctor Allergies 98

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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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. 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. If necessary, licensed abatement contractors can handle asbestos removal.

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The Pharma Data

AUGUST 20, 2020

. “The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed.” Source link.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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Pharma in Brief

MARCH 21, 2022

Also reported was Health Canada’s intention to introduce transition regulations, which would have ended the expedited IO authorization pathway but extended current IO authorizations so that industry could meet therequirements for converting their IO approvals to medical device licenses under the Medical Devices Regulations (the Regulations ).

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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.) North Dakota.

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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). Anozem 2% cream – contains diltiazem 2%. One over the counter haemorrhoid sprays contains the same combination of active ingredients.

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Drug Discovery World

FEBRUARY 1, 2023

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. Germany only has three licenses, and the current facilities are a small fraction of total sales.

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Drug Discovery World

AUGUST 21, 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.

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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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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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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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Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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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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