Emergent to acquire Protien Sciences’ FluBlock, BEVS
ROCKVILLE, Md., and MERIDEN, Conn. Emergent BioSolutions and Protein Sciences have entered into an asset purchase agreement under which Emergent will acquire Protein’s ongoing operation, including FluBlok, a phase III recombinant influenza vaccine candidate, and certain other assets including its Baculovirus Expression Vector System technology.
BEVS is a cell culture-based manufacturing platform used to manufacture FluBlok. The BEVS technology can be applied to develop vaccines and therapeutic candidates to prevent or treat a wide range of diseases. Emergent will also acquire other product candidates. PSC’s other product candidates are based on the BEVS platform and include a SARS vaccine in preclinical development. Also, Emergent acquires a vaccine manufacturing facility. This facility is located in Meriden, Connecticut and includes a 600-liter bioreactor and related upstream and downstream capabilities.
“We are delighted about the opportunity to commercialize the first recombinant cell culture influenza vaccine. We believe that FluBlok will become a strong competitive product in the sizeable and growing seasonal influenza market and that BEVS will provide a unique platform for the development of a novel pandemic influenza candidate. We congratulate the management of PSC in building a manufacturing operation and for bringing FluBlok through a Phase III clinical trial to the point of a BLA submission. Emergent, with the combined resources of PSC, is well positioned to bring this exciting product to the market successfully, based on our product development, regulatory and manufacturing experience,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “The acquisition of FluBlok is consistent with Emergent’s strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease.”
FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
FDA issues approvable letter for Wyeth osteoporosis drug
WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.
The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.
Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.
RELATED NEWS
FDA approves Lupin’s Tamiflu generic
The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths. The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.Read more
Genoa marks telepsychiatry milestone
Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform. Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.Read more
This year’s flu activity threatens to become ‘Texas big’
This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6. Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.Read more
Amneal introduces Busulfex generic
Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia. Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said. The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.Read more
Amneal’s generic Renvela comes to market
Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela. Amneal also launched five other products in addition to sevelamer carbonate:Read more
- facebook
- twitter
- linkedin
- envelope
- print
keyboard_arrow_downCOMMENTSNo comments found