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

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

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

XTalks

SEPTEMBER 20, 2023

UPSIDE Foods, a California-based company, received FDA approval for its chicken grown from animal cells, which marked a significant milestone for slaughter-free meat in the US. The concept of hybrid meat has emerged as a sustainable compromise to the ongoing debate about meat consumption.

Contamination 64

Contamination Protein Production FDA Approval 64

Camargo

AUGUST 5, 2021

Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. In July, Astellas Pharma US received FDA approval for the use of Prograf (tacrolimus) capsules, injection, and oral suspension for the prevention of lung transplant rejection.

Development 232

Development Production Regulation Clinical Trials 232

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

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

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 Compliance 71

Drug Discovery World

MAY 11, 2023

In addition, there are other sources of protein contamination, such as from cell culture medium supplements — for example, bovine serum albumin.” coli, and Pichia cells. These host cells alone contain over a thousand HCPs.

Production 52

Production Gene Protein Vaccination 52

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 Regulation Drugs 68

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.

Vaccination 64

Vaccination Vaccine Contamination Contract Manufacturing 64

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

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).

Vaccination 40

Vaccination Vaccine Production Sales 40

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