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52102 items
4:55 PM, Nov 16, 2018  |  BC Extra | Company News

Tesaro stock rebounds on takeout report

Tesaro Inc. (NASDAQ:TSRO) declined to comment on a report of a potential sale that drove the company's stock up $8.37 (31%) to $34.96 on Friday. Tesaro has engaged advisers to explore a sale after receiving takeout...
4:55 PM, Nov 16, 2018  |  BC Extra | Financial News

Centrexion steps back from IPO amid volatile market

A decision by pain company Centrexion Therapeutics Corp. (Boston, Mass.) to not move forward with its NASDAQ IPO comes as market volatility has increased and several biotechs have failed to hit their desired valuations. In the...
4:18 PM, Nov 16, 2018  |  BC Extra | Preclinical News

Spotlight co-founder uses CRISPR screen to ID T cell regulator genes for cancer

Spotlight Therapeutics Inc. (Hayward, Calif.) co-founder Alexander Marson and colleagues at University of California San Francisco developed a CRISPR-based screen to identify genes that control T cell replication and immunosuppression, and used the results to...
4:10 PM, Nov 16, 2018  |  BC Extra | Company News

Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics Inc. (NASDAQ:SGEN) submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell...
4:06 PM, Nov 16, 2018  |  BC Extra | Company News

Novartis joins call asking FDA to stop biosimilar trash-talkers

Novartis AG (NYSE:NVS; SIX:NOVN) joined Pfizer Inc. (NYSE:PFE) in asking FDA to stop campaigns from branded drugmakers that the pharmas say are misleading the public about the safety of biosimilars. Novartis submitted its comments in...
4:03 PM, Nov 16, 2018  |  BC Extra | Politics & Policy

Postmarketing study delays increase, but Gottlieb hopeful on progress

Despite a slight slip in numbers for on-schedule postmarketing studies, FDA Commissioner Scott Gottlieb sounded a positive note when he reported the agency's progress in holding companies accountable. In a statement Friday, he also said...
3:22 PM, Nov 16, 2018  |  BC Extra | Financial News

Alphamab Oncology raises more than $100M series A

Immuno-oncology company Alphamab Oncology (Suzhou, China) raised over $100 million in a series A round to accelerate development of its biologics including lead product KN035. Advantech Capital, PAG, China Venture Capital Fund, OrbiMed Advisors, Heritage...
3:19 PM, Nov 16, 2018  |  BC Extra | Politics & Policy

As Finance chair, Grassley will become gatekeeper of biopharma bills

Sen. Chuck Grassley (R-Iowa) said he will opt to serve as chairman of the Senate Finance Committee for the term beginning January, giving him the power to decide which drug pricing legislation makes it to...
2:54 PM, Nov 16, 2018  |  BC Extra | Company News

Pfizer to increase list price of 41 drugs

Pfizer Inc. (NYSE:PFE) said it plans to increase the list price for 41 medicines, effective Jan. 15. Last month, Chairman and CEO Ian Read said the pharma will likely end its agreement to defer drug...
2:19 PM, Nov 16, 2018  |  BC Extra | Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed fexinidazole,...