Pharmacy Checkers

NOVEMBER 21, 2019

I have summarized the main FDA roles, as carried out by CEDR and ORA, in protecting the U.S. For example, the agency started the Office of Pharmaceutical Quality (OPQ) in 2015, which is entirely dedicated to making sure FDA-approved drugs are of high quality. Dissecting Criticism of the FDA: Inspections & Sovaldi’s Approval.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.

Regulation 130

Regulation Contamination Manufacturing Production 130

pharmaphorum

JUNE 28, 2022

Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in February.

Drugs 105

Drugs Contamination Sales Marketing 105

Pharmaceutical Technology

APRIL 4, 2023

US heavily reliant on Indian generics The US is over-reliant on India for generic drug supply and that is reflected in the abundance of FDA-approved drug manufacturing sites in southern India. Most sites in Andhra Pradesh and Telangana had FDA and/or EMA approval (297 out of a total 476 sites). ©GlobalData.

Manufacturing 130

Manufacturing Generic Drugs Contract Manufacturing Production 130

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

Sales 52

Sales Insulin FDA Approval Drugs 52

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Roche also expressed hope for its two CD20xCD3 bispecific T-cell engager immunotherapies Columvi and Lunsumio that received FDA approval in 2023 and 2022, respectively. billion, an increase of 10.8

Pharma Companies 52

Pharma Companies Sales FDA Approval Vaccine 52

pharmaphorum

DECEMBER 23, 2022

Gilead Sciences has claimed FDA approval for Sunlenca, a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, at the second time of asking. The post FDA approves twice-yearly resistant HIV therapy from Gilead appeared first on.

FDA Approval 52

FDA Approval Contamination Marketing RNA 52

pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

Vaccine 63

Vaccine Vaccination Contamination Contract Manufacturing 63

XTalks

OCTOBER 16, 2020

The FDA approval is based on results from the large, multi-center clinical trial called PALM (PAmoja TuLinde Maisha) in which Inmazeb showed superiority over other antiviral investigational agents, namely ZMapp and remdesivir, with respect to mortality.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Vaccine 40

Vaccine Vaccination Production Sales 40

Cloudbyz

AUGUST 19, 2024

Answer: Entering the global market requires compliance with various international regulations and standards, including: Regulatory Approval: Devices must meet the regulatory requirements of each country where they will be marketed, such as FDA approval in the U.S., CE marking in the EU, or TGA approval in Australia.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

FDA Approval 130

FDA Approval Bacteria Contamination Pharma Companies 130

Pharmacy Checkers

DECEMBER 12, 2019

In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Why do I write “exact same”?

Drugs 71

Drugs Manufacturing Medicine Regulation 71

XTalks

JANUARY 6, 2025

Notably, the ASO drug Vitravene (fomivirsen) received US Food and Drug Administration (FDA) approval for treating cytomegalovirus (CMV) retinitis in AIDS patients. This reduces human error and contamination risks, ensuring higher-quality production outcomes.

Gene Therapy 111

Gene Therapy RNA Gene Editing Gene 111