Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval
Acting FDA Commissioner Janet Woodcock earlier this month asked the Office of the Inspector General at the Department of Health…
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Browsing Tag
Biogen
Biogen gets US FDA accelerated approval for Aduhelm to treat Alzheimer’s
It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental…
Biogen applies for approval of Alzheimer’s drug, aducanumab in Japan
Biogen and Eisai have jointly developed three experimental drugs for Alzheimer’s
Glenmark Pharmaceuticals gets ANDA approval for multiple sclerosis drug
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for dimethyl…
Lupin gets US FDA approval for dimethyl fumarate delayed release capsules
According to IQVIA MAT June 2020 data, dimethyl fumarate delayed-release capsules had an annual sales of approximately USD 3788…
Mylan announces launch of generic version of Biogen’s Tecfidera
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS)
Biogen to study Spinraza in combination with $2-mn Novartis drug
The one-a-day oral drug is viewed as a potential a rival to Spinraza, which is administered every four months via spinal infusion
Biogen moves forward with potential Alzheimer’s drug, seeks US FDA’s approval
The drug, aducanumab, has had a tumultuous journey, with promising early data raising hopes and Biogen’s share price, only to be…
Healthcare industry reports 70 deals worth $3.2-bn in Jan ’20
The healthcare industry reported 98 VC deals worth $1.9-billion in January 2020, compared to the last 12-month average of 103…
Roche’s SMA drug trial win bolsters $2 billion sales prospects
US regulators are due to decide by May 24