BioCentury | Jul 16, 2020
Regulation

July 15 Quick Takes: Early access in U.K. for Alnylam RNAi; plus Verrica, CytoDyn, J&J and Roche

U.K. clears early access to lumasiran  The U.K.’s Medicines and Healthcare products Regulatory Agency is making lumasiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) available to patients with primary hyperoxaluria type I before its approval by the...
BioCentury | Apr 24, 2020
Finance

Big gain for ORIC in trading debut after pricing upsized IPO

By posting a big gain Friday after pricing an upsized IPO at the top end of its range, ORIC provided another encouraging data point to biotechs seeking to test the public markets, suggesting that investors...
BioCentury | Apr 22, 2020
Finance

April 21 Financial Quick Takes: ORIC’s IPO plans; plus venture rounds for Magpie, Cloudbreak, ReAlta, New Horizon, Zikani

ORIC sets terms for planned IPO In an updated prospectus, oncology company ORIC Pharmaceuticals Inc. proposed to sell 5 million shares at $14-$16 in a planned IPO on NASDAQ. At the midpoint, a sale of...
BioCentury | Mar 26, 2020
Regulation

China’s NMPA suspends Abraxane imports after U.S. inspection

China’s suspension of the importation and sale of Celgene’s Abraxane by BeiGene following an inspection at a U.S. manufacturing site demonstrates how far the country has come in its drive to ensure safety of drugs,...
BC Extra | Jan 23, 2020
Politics & Policy

MNCs lead price cuts in China’s second round of centralized procurement

MNC originators took the deepest price cuts in the second round of China’s expanded centralized procurement program for generic and off-patent drugs. A list released Tuesday by China’s Joint Procurement Office showed that 77 winning...
BC Extra | Jan 22, 2020
Clinical News

BeiGene gearing up for PD-1 competition with Merck, Innovent in 1L squamous NSCLC in China

BeiGene announced Tuesday that tislelizumab met the primary endpoint in a Chinese Phase III trial for first-line squamous non-small cell lung cancer. The readout keeps BeiGene’s PD-1 mAb on track as it vies with Innovent’s...
BC Extra | Jan 7, 2020
Company News

BeiGene looks to carve out niche in China for tislelizumab

As it looks to roll out what will be at least the sixth marketed PD-1 inhibitor in China, BeiGene hopes the therapy’s differentiated efficacy profile and commercial infrastructure will help the company carve a niche...
BC Extra | Dec 31, 2019
Company News

Dec. 31 Company Quick Takes: A first for BeiGene; plus MorphoSys, Junshi-CSPC, Acceleron-Fulcrum and Solasia-EditForce

First-ever China approval for homegrown BeiGene drug  China’s National Medical Products Administration approved anti-PD-1 mAb tislelizumab from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) to treat classical Hodgkin lymphoma in a third-line setting. The approval is the first...
BC Extra | Dec 31, 2019
Politics & Policy

China’s expanded list of drugs for centralized procurement comes with new rules

Following the nationwide expansion of China’s pilot program for centralized procurement of generics and off-patent originator drugs, Beijing is adding a second group of 33 drugs and unveiling new rules that could increase the number...
BC Innovations | Dec 19, 2019
Distillery Therapeutics

Raising PDLIM2 expression to treat lung cancer

DISEASE CATEGORY: Cancer INDICATION: Lung cancer Promoting the expression of PDLIM2, which has been proposed to have tumor suppressor functions, could treat lung cancer. In lung cancer patients, PDLIM2 RNA levels were lower in tumor...
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