Pharma in Brief

JANUARY 10, 2024

The Federal Court refused to issue an injunction in a case where an antibody formulation patent was found to be valid and infringed (see here ). The US Food and Drug Administration kicked off 2024 by authorizing the first drug importation program by a US State (Florida) under section 804 of the US Food, Drug, and Cosmetic Act (see here ).

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Regulation Drugs Production Medicine 52

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

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The Pharma Data

APRIL 18, 2022

The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies. Reactions to some non-listed food allergens have relatively low prevalence rates, with some as low as single cases.

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XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. What is a Biosimilar? Biosimilars are the “generic” drugs of the biopharma world.

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The Pharma Data

APRIL 30, 2021

Global Botox Cosmetic net revenues were $477 million , an increase of 44.7 Botox Cosmetic*. Global Venclexta net revenues were $405 million , an increase of 27.9 percent on a reported basis, or 24.5 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.141 billion , an increase of 34.9 Imbruvica d.

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Botox Production Development Cosmetics 40

Roots Analysis

AUGUST 8, 2023

Ligand-targeted Liposomes: These liposomes can be employed for site- specific targeting by attaching ligands (including antibodies, peptides, and carbohydrates) to their surface or to the terminal end of the attached PEG chains.

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Drug Delivery Systems Drug Delivery Drugs In-Vivo 52

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

AUGUST 1, 2021

Global Botox Cosmetic net revenues were $584 million, an increase of over 100.0 to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Global Ubrelvy net revenues were $126 million. Global net revenues from the aesthetics portfolio were $1.434 billion, an increase of over 100.0

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Botox Cosmetics Trials Clinical Trials 52

The Pharma Data

MARCH 29, 2022

Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose. Source link: [link].

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The Pharma Data

DECEMBER 31, 2020

Purdue pleaded guilty to one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

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Vaccination Vaccine Cosmetics Drugs 52

FDA Law Blog

NOVEMBER 8, 2022

To put it into perspective, these were the numbers (so far) for in vitro diagnostics EUAs: 304 molecular, 84 antibody, 51 antigen, and 5 other. CDRH’s pandemic responses included more than 4,000 medical devices authorized. This includes EUAs and full marketing authorizations.

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Regulation In-Vitro Production Marketing 59