XTalks

FEBRUARY 5, 2024

It represents the inaugural targeted therapy designed to impede the DNA damage response (DDR) in cells or tumors exhibiting a deficiency in homologous recombination repair (HRR), notably those with mutations in BRCA1 and/or BRCA2 or those where deficiency is induced by other agents, such as DNA-damaging chemotherapies.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

FEBRUARY 5, 2024

It represents the inaugural targeted therapy designed to impede the DNA damage response (DDR) in cells or tumors exhibiting a deficiency in homologous recombination repair (HRR), notably those with mutations in BRCA1 and/or BRCA2 or those where deficiency is induced by other agents, such as DNA-damaging chemotherapies.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

AUGUST 2, 2023

But all three drugs have new competitors. Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. 5) Lynparza (Olaparib) Lynparza is a PARP inhibitor , meaning it inhibits poly ADP ribose polymerase (PARP), an enzyme involved in DNA repair. Both are anti-CD20 agents.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. By 2010, about 2000 isolated human genes had been patented in the U.S. animal, viral, bacterial) DNA and RNA sequences.

Gene 64

Gene DNA Genetics Gene Sequencing 64

XTalks

SEPTEMBER 14, 2020

Unlike COVID-19 tests that need to be processed through PCR machines, the new rapid test is processed through a handheld DNA analyzer. Results are available in about 15 minutes, so the test is much faster than currently available tests which detect viral genes.

Vaccine 92

Vaccine Vaccination Antibody Life Science 92