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FDA Grants Breakthrough Therapy Designation for UGN-101 americanpharmaceuticalreview
October 31, 2018
UroGen Pharma announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for....
Even in worst-case scenario, Roche will grow past biosimilar erosion in the U.S.: executive fiercepharma
October 19, 2018
Roche’s trio of megablockbuster cancer drugs, Herceptin, Rituxan and Avastin, still held their ground in the third quarter, despite a biosimilar onslaught in Europe. And though next year will be a different story, thanks to U.S. ...
U.S. Court of Appeals Upholds District Court’s Decision to Invalidate Ampyra Patents americanpharmaceuticalreview
September 12, 2018
Acorda Therapeutics announced that the United States Court of Appeals for the Federal Circuit, by a 2-1 vote, has upheld the United States District Court for the District of Delaware’s decision to invalidate four Ampyra patents. This decision affirms the
SpinalCyte Announces New U.S. Patent americanpharmaceuticalreview
August 29, 2018
SpinalCyte announced issuance of U.S. Patent No. 10,052,410, “Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor.”
FDA Approves New Treatment for Rare Hereditary Disease americanpharmaceuticalreview
August 27, 2018
The U.S. Food and Drug Administration (FDA) approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S.
FDA Adds Four Tropical Diseases to Priority Review Voucher Program americanpharmaceuticalreview
August 27, 2018
The U.S. Food and Drug Administration (FDA) announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases.
Thermo Fisher Opens U.S. Precision Medicine Science Center contractpharma
June 19, 2018
Thermo Fisher Scientific has opened its U.S. Precision Medicine Science Center (PMSC) in Cambridge, MA. The center offers access to advanced "omics" technologies and expertise to help collaborators develop analytical workflows that generate precise molecu
Strict Handgun Laws Lower Gun-Murder Rates in Cities drugs
June 12, 2018
U.S. states that require police background checks for a handgun license see 14 percent fewer gun murders in their urban counties, a new study found.
Ipsen moves U.S. headquarters to Kendall Square fiercebiotech
June 11, 2018
Ipsen is moving its U.S. headquarters to Kendall Square in Cambridge, Massachusetts. The French drugmaker is the latest in a series of European companies to pick the biotech hotspot as their U.S. base.
A Description of the Market Data of the 9 Marketed Biosimilars in the U.S. Dopine
May 28, 2018
The marketing of many biosimilars has met resistance in the U.S. recently as FDA sent CRLs for them.

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