BioCentury | Jul 13, 2019
Tools & Techniques

Broadening role for external control arms in clinical trials

External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between...
BC Extra | May 7, 2019
Company News

May 7 Company Quick Takes: Akcea, Bicycle/DDF, Arbutus, Celgene/Sutro, MDGH, Pfizer, Sanofi/Regeneron

Akcea's Waylivra approved in EU  The European Commission granted conditional approval to Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) as an adjunct to diet in adult patients with familial chylomicronemia...
BC Innovations | Apr 10, 2019
Distillery Therapeutics

Antibody-drug conjugate targeting ALK could treat neuroblastoma

DISEASE CATEGORY: Cancer INDICATION: Neuroendocrine tumors Cell and mouse studies identified an ALK-targeting antibody-drug conjugate (ADC) that could help treat neuroblastoma. The ADC consists of an anti-ALK mAb linked to the generic chemotherapy drug thienoindole....
BC Week In Review | Nov 9, 2018
Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up...
BC Extra | Nov 2, 2018
Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
BioCentury | Oct 6, 2018
Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
BioCentury | Sep 7, 2018
Strategy

Thinking beyond Bi

Following the resignation of Jingquan Bi, early signs for continued biopharma regulatory reform in China remain positive. But the IP reforms spearheaded by Bi look to have fallen off the government’s priority list, and there...
BC Extra | Aug 20, 2018
Company News

China approves Roche’s Alecensa for NSCLC

Roche (SIX:ROG; OTCQX:RHHBY) said China’s State Drug Administration approved Alecensa alectinib as monotherapy to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. FDA and EMA approved the drug for the indication in November...
BioCentury | Jul 13, 2018
Strategy

Roche’s partnering priority

As James Sabry gets set to lead partnering for all of Roche pharma, his first order of business might be to build out the company’s late-stage pipeline ahead of an impending patent cliff that puts...
BioCentury | Mar 9, 2018
Strategy

Accelerating Flatiron

Roche isn’t saying much about how it approached the decision to shell out $1.9 billion to acquire the 87% of Flatiron Health Inc. it didn’t already own. But it appears that Flatiron would have needed...
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