00:52 , Jan 23, 2019 |  BC Extra  |  Company News

Management tracks: GSK, A*STAR, Moderna

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Philip Hampton will step down as chairman ahead of the pharma’s planned split of its consumer healthcare and innovative R&D businesses. The pharma said it has started to search for...
21:22 , Jan 18, 2019 |  BioCentury  |  Politics, Policy & Law

Pharma falling off budget cliff

Three strong arms are lining up in Washington to take turns whacking the biopharma piñata. Divisions within the industry, a lack of new ideas, and resistance to change are making a bad situation worse for...
20:32 , Jan 18, 2019 |  BC Week In Review  |  Clinical News

BeiGene's BTK inhibitor gets U.S. breakthrough designation

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said FDA granted breakthrough therapy designation to zanubrutinib (BGB-3111) to treat second-line mantle cell lymphoma (MCL). BeiGene President and General Manager of China Xiaobing Wu told BioCentury zanubrutinib is the first...
18:56 , Jan 17, 2019 |  BC Week In Review  |  Company News

Pfizer drops preclinical biosimilar programs

Pfizer Inc. (NYSE:PFE) will cease development of its five preclinical biosimilar programs; the discontinued programs are undisclosed. Pfizer spokesperson Thomas Biegi said the decision, which was based on the pharma's annual R&D investment review, is...
22:54 , Jan 15, 2019 |  BC Week In Review  |  Clinical News

FDA reviewing Pfizer's TTR amyloid cardiomyopathy therapy

Pfizer Inc. (NYSE:PFE) said FDA accepted for review two NDAs for tafamidis to treat transthyretin (TTR) amyloid cardiomyopathy based on two forms of the compound. The NDA for the tafamidis meglumine form was granted Priority...
23:43 , Jan 14, 2019 |  BC Extra  |  Politics & Policy

House begins campaign to publicize and politicize drug pricing

Requests for pricing and cost information sent Monday by the House Oversight and Reform Committee to a dozen biopharma companies mark the start of what is certain to be a sustained campaign by House Democrats...
23:20 , Jan 14, 2019 |  BC Extra  |  Company News

BeiGene's Btk inhibitor gets U.S. breakthrough designation

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said FDA granted breakthrough therapy designation to zanubrutinib (BGB-3111) to treat second-line mantle cell lymphoma (MCL). BeiGene President and General Manager of China Xiaobing Wu told BioCentury zanubrutinib is the first...
20:28 , Jan 14, 2019 |  BC Extra  |  Company News

FDA reviewing Pfizer's TTR amyloid cardiomyopathy therapy

Pfizer Inc. (NYSE:PFE) said FDA accepted for review two NDAs for tafamidis to treat transthyretin (TTR) amyloid cardiomyopathy based on two forms of the compound. The NDA for the tafamidis meglumine form was granted Priority...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month's gains and losing $291.2 billion in aggregate value. Median losses...
21:35 , Jan 11, 2019 |  BioCentury  |  Emerging Company Profile

Artios: Probing DNA Damage

With programs in-licensed from Cancer Research UK and Masaryk University, Artios Pharma Ltd. thinks it has next-generation DNA damage response programs that could improve upon PARP inhibitors -- and the funds to take them to...