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4:24 PM, Jun 14, 2018  |  BC Extra | Politics & Policy

CREATES could face uphill battle in Senate

The Senate Judiciary Committee approved legislation on Thursday to limit the ability of branded pharmaceutical companies to block generic companies from accessing drug samples through REMS. But the Creating and Restoring Equal Access to Equivalent...
3:40 PM, Jun 14, 2018  |  BC Extra | Company News

Mylan expecting another delay for generic Advair

Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK). Any delay would be a reprieve...
2:05 PM, Jun 14, 2018  |  BC Extra | Company News

Priority Review in China for Pharnext's PXT3003

Pharnext S.A.S. (Euronext:ALPHA) said China's State Drug Administration granted Priority Review to an NDA for PXT3003 to treat Charcot-Marie-Tooth 1A (CMT1A) disease. GeneNet Co. Ltd. (Tianjin, China), a joint venture between Pharnext and Tasly Pharmaceutical Co....
1:41 PM, Jun 14, 2018  |  BC Extra | Company News

FDA approves moxidectin for river blindness

Medicines Development for Global Health (Southbank, Australia) said FDA approved its NDA for moxidectin to treat onchocerciasis, commonly known as river blindness, in patients at least 12 years old. MDGH received a Priority Review voucher...
11:38 AM, Jun 14, 2018  |  BC Extra | Clinical News

ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads...
11:06 PM, Jun 13, 2018  |  BC Extra | Financial News

Syncona backs pair of gene therapy start-ups

Syncona Ltd. (LSE:SYNC) launched SwanBio Therapeutics Ltd. (Boston, Mass.) and Orbit Biomedical Ltd. (Philadelphia, Pa.), a pair of gene therapy newcos for CNS and retinal disorders, respectively. The U.K. investment firm provided $23 million of SwanBio's...
6:12 PM, Jun 13, 2018  |  BC Extra | Company News

Shionogi gains Asian rights to SAGE-217

Shionogi & Co. Ltd. (Tokyo:4507) licensed exclusive rights to SAGE-217 from Sage Therapeutics Inc. (NASDAQ:SAGE) in Japan, Taiwan and South Korea to treat major depressive disorder (MDD). Shionogi will pay Sage $90 million up front,...
5:32 PM, Jun 13, 2018  |  BC Extra | Politics & Policy

BIO doubles down as party sponsors add distance

BIO Workplace Development, Diversity and Inclusion Committee Chair Helen Torley told BioCentury on Wednesday that the committee "fully supports" BIO's decision to have President and CEO Jim Greenwood call sponsors of the Party at Bio...
5:05 PM, Jun 13, 2018  |  BC Extra | Preclinical News

Cellectis unveils safety CAR construct

In an effort to mitigate adverse effects associated with CAR T therapies, researchers at Cellectis S.A. (NASDAQ:CLLS; Euronext:ALCLS) and its collaborator Allogene Therapeutics Inc. (South San Francisco, Calif.) developed an integrated safeguard for CAR T...
4:41 PM, Jun 13, 2018  |  BC Extra | Financial News

British Business Bank launches patient investment fund

British Business Bank launched British Patient Capital on Wednesday, a £2.5 billion ($3.4 billion) investment fund that the bank will invest in U.K. businesses, including bioscience companies, alongside private investors. British Patient Capital fulfills a commitment...

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