Chemo's Generic Estradiol Receives Approval in the U.S.
Five years after Bristol Myers Squibb’s Celgene filed a petition with the FDA as part of an attempt to delay the launch of generic versions of its blockbuster chemo Abraxane, the agency has finally, and almost completely, rejected the petition.
AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen to support clinical testing and launch readiness.
An aggressive type of brain cancer, glioblastoma has no cure. Patients survive an average of 15 months after diagnosis, with fewer than 10% of patients surviving longer than five years. While researchers are investigating potential new therapies via ongoing clinical trials, a new study suggests that a minor adjustment to the current standard treatment -- giving chemotherapy in the morning rather than the evening -- could add a few months to patients' survival.
Chemo India Formulations, a subsidiary of Spanish drug company Chemo Group, has opened its first R&D and pharmaceutical manufacturing facility with an initial investment of Rs 100 crore in Hyderabad. The company plans to produce oral solid dosage forms, including tablets, caplets, hard gelatin capsules and pellets.
Benznidazole is an essential medicine for Chagas disease, a dangerous parasitic disease that affects an estimated 6 to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.
The U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.nBenznidazole is an essential medicine for Chagas disease, a dangerous parasitic disease that affects an estimated 6 to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.