The Pharma Data

OCTOBER 18, 2020

At-home COVID-19 testing adds additional capability to an already robust menu including pooled testing, antibody testing, wastewater, used-mask, and soon to be launched saliva testing. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. View source version on businesswire.com: [link]. Source link.

Cosmetics 52

Cosmetics Nurses Antibody Drugs 52

Roots Analysis

AUGUST 15, 2023

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

Protein 52

Protein In-Vitro Production Reagent 52

Roots Analysis

SEPTEMBER 9, 2024

The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines , is driving advancements in protein expression technology to ensure efficient and scalable production. Prokaryotic Expression System: This expression system is used in structural analysis, antibody generation and functional assays.

Protein 40

Protein Gene Production DNA 40

XTalks

NOVEMBER 1, 2024

Price of Ocrevus: $78,858 annually Why it sold so well: Ocrevus is a therapeutic monoclonal antibody that offers a unique scientific approach to treating MS. It specifically targets CD20-positive B cells, a type of immune cell that plays a crucial role in the progression of the disease.

FDA Approval 85

FDA Approval Drugs Botox Sales 85

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

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs In-Vivo 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].

Vaccine 52

Vaccine Vaccination FDA Approval Immune Response 52

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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Production Insulin Branding Generic Drugs 78

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 ).

Regulation 52

Regulation Drugs Production Medicine 52

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

Botox 52

Botox Cosmetics Trials Clinical Trials 52

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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Production Drugs FDA Approval Compliance 59

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.

Botox 40

Botox Production Development Cosmetics 40

FDA Law Blog

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. 1, 2023, sesame.

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Cosmetics Allergies Production Containment 105

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.

Vaccine 52

Vaccine Vaccination 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.

Regulation 59

Regulation In-Vitro Production Marketing 59