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. The Utility of cfDNA for Cancer Management and Predicting Outcomes.

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

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. The post Gilead tries again with twice-yearly HIV drug lenacapavir appeared first on.

Drugs 105

Drugs Contamination Sales Marketing 105

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

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Drug Discovery World

MAY 11, 2023

If they are not detected and removed during purification, process-related impurities can alter drug quality or evoke undesired immunogenic reactions in the patient. Novel gene-based drugs can be severely impacted when HCPs are not distinguished and quantified individually. coli, and Pichia cells.

Production 52

Production Gene Protein Vaccination 52

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

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. Food and Drug Administration. Frontiers Molecular Biosciences.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

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

XTalks

OCTOBER 16, 2020

The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the world’s first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients, including newborns of mothers who have tested positive for the virus.

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). If approved, TicoVac would be the first vaccine in the U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40