India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
Biocon Ltd. said its subsidiary Biocon Biologics Ltd. has agreed to buy out partner Viatris Inc., bringing aboard the latter’s biosimilars business, for $3.34 billion.
Biocon Ltd. said its subsidiary Biocon Biologics Ltd. has agreed to buy out partner Viatris Inc., bringing aboard the latter’s biosimilars business, for $3.34 billion, including cash of $2.34 billion and compulsorily convertible preference shares (CCPS) in BBL, valued at $1 billion.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent.
HYDERABAD, India – India could play a key role in driving down the exorbitant cost of emerging cell and gene therapies, with a combination of comparatively cheap labor and efficient manufacturing, international experts said during the annual BioAsia conference.
HYDERABAD, India – India could play a key role in driving down the exorbitant cost of emerging cell and gene therapies, with a combination of comparatively cheap labor and efficient manufacturing, international experts said during the annual BioAsia conference.