Gland Pharma on Monday said it has received approval from the US health regulator to market a generic medication used to treat breast cancer. The company has received approval from the US Food and Drug Administration (USFDA) for Eribulin Mesylate Injection (0.5 mg/mL single dose vial), it said in a statement.
The US Food and Drug Administration cleared the medicine for patients who have HER2-positive solid tumors that have spread or can’t be removed with surgery, the company said. These patients have already received prior treatment and don’t have any good alternatives.
The Mumbai-headquartered biopharmaceuticals company was acquired by US-based investor Advent International from its previous owners, the Daftary family, for an undisclosed sum in 2019. Advent, which is now the 100%-owner of BSV, wants to sell the company.
The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing.
The agreement licenses the company to launch in the US in February 2025, once approved by the US Food and Drug Administration(USFDA), Biocon Biologics said in a statement. The company's product -- Bmab 1200 -- is a proposed biosimilar to the reference drug Stelara which had sales of USD 7 billion in the US last year.
Orchid Pharma on Friday said it has received approval from the US health regulator to market a medication used to treat patients with complicated urinary tract infection. The drug firm has received new drug approval from the US Food and Drug Administration (USFDA) for Enmetazobactam, Orchid Pharma said in a statement.
The company aims to expand accessibility to MRIs and streamline the diagnostic process with actionable imaging in time-sensitive environments, particularly for patients who are unable to undergo conventional MRI scans. This neuro42 MRI will be launched in the US market later this year.
While most patients recover fully, chikungunya disease can prove fatal. Despite infections going largely unreported, approximately five lakh cases and over 400 deaths were recorded worldwide in 2023, the researchers said.
The drug major said its R&D centre -- Integrated Product Development Organisation -- in Bachupally, Hyderabad, underwent a Good Manufacturing Practice and pre-approval inspection by the US Food and Drug Administration (USFDA) in December 2023.
The first reported demonstration of a brain-computer interface occurred in 1963. During a lecture at the University of Oxford, neuroscientist William Grey Walter bewildered his audience by linking one of his patient's brains to the projector, where they advanced the slides of his presentation using only their thoughts.
As per IQVIA data, the product had an annual sales of USD 85 million in the US. Shares of Zydus were trading 2.27 per cent down at Rs 735.30 apiece on the BSE.
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