Teva receives complete response letter for Neutroval
JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.
Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.
Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.
Waiting period for Bristol-ZymoGenetics deal expires
NEW YORK The Hart-Scott-Rodino waiting period for Bristol-Myers Squibb’s acquisition of Seattle-based biotech company ZymoGenetics has expired, enabling Bristol’s acquisition to go through, the drug maker said Tuesday.
The drug maker announced the deal to acquire ZymoGenetics for $885 million, or $9.75 per share, earlier this month.
The buyout gives Bristol ownership of Recothrom, a drug used to control bleeding during surgical procedures; an investigative treatment for hepatitis C called pegylated-interferon lambda; and an investigative treatment for melanoma called interleukin-21, or IL-21.
Valeant, Biovail become one
MISSISSAUGA, Ontario The merger between Valeant Pharmaceuticals International and Biovail is complete, the two companies said Tuesday.
Shareholders of both companies have approved the merger, worth more than $3 billion, originally announced in June.
The combined company will take Valeant’s name.