17:37 , Mar 18, 2019 |  BC Extra  |  Clinical News

Dermira jumps on Phase IIb atopic dermatitis readout

Dermira added $5.70 (83%) to $12.54 in afternoon trading Monday after reporting that all three doses of lebrikizumab met the primary endpoint in a Phase IIb trial to treat adults with moderate-to-severe atopic dermatitis. Dermira...
22:01 , Mar 15, 2019 |  BioCentury  |  Product Development

Broadening the PARP playing field

With its latest clinical win for Lynparza, AstraZeneca is leading the field in stretching the use of PARP inhibitors beyond tumors that carry BRCA mutations. The results highlight one piece of a broader strategy companies...
21:01 , Mar 15, 2019 |  BC Extra  |  Company News

ICER suggests Novartis' MS therapy siponimod won't be cost-effective

ICER said the price of multiple sclerosis therapy Mayzent siponimod from Novartis would have to reach a monthly net price of $995 to meet its standard cost-effectiveness threshold of $150,000 per QALY. That price would...
18:05 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Lilly looks to expand Cyramza's label into first-line NSCLC

Eli Lilly said it plans to initiate global regulatory applications mid-year seeking to expand the label of Cyramza ramucirumab to include first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have activating...
02:41 , Mar 15, 2019 |  BC Innovations  |  Product Development

Fresh AIMMs for elite responders

AIMM Therapeutics B.V.’s elite responder platform has identified mAbs that distinguish tumor and healthy cells based on protein modifications. The company is one of a handful of players mining the immune systems of cancer patients...
00:29 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Syndax pauses entinostat-PD-1/PD-L1 combo program

Syndax said in its 4Q18 financial results that it will "defer advancement" of its program evaluating entinostat plus PD-1/PD-L1 inhibitors after the combinations missed the primary endpoints of improving progression-free survival (PFS) in a pair...
14:34 , Mar 14, 2019 |  BioCentury  |  Politics, Policy & Law

Love it or hate it, the myopic IPI won’t lower Medicare drug prices

The Trump administration has proposed that the U.S. pay similar prices to what companies charge in Europe, starting with drugs covered under Medicare Part B. The administration figures that pegging U.S. prices to an International...
02:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Sharpless has the edge on FDA job

Norman (Ned) Sharpless, director of the National Cancer Institute, is the leading candidate to take over FDA leadership, Trump administration officials told BioCentury. HHS Secretary Alex Azar hasn’t made a final decision, the officials said....
00:04 , Mar 9, 2019 |  BC Extra  |  Company News

Management tracks: Lundbeck hires first CBO; ICT opens U.S. office

Neurology company Lundbeck hired Keld Flintholm Jørgensen as its first CBO. Jørgensen, who will begin at H. Lundbeck A/S (CSE:LUN) April 4, is global head of strategic partnering at Roche (SWX:ROG;OTCQB:RHHBY). Innovative Cellular Therapeutics Co....
18:43 , Mar 8, 2019 |  BC Week In Review  |  Clinical News

Genentech's algorithm enhances accuracy of macular disease detection

Genentech Inc. said that by applying its deep learning algorithm to color fundus photographs (CFPs), it was able to detect diabetic macular edema (DME) with up to 97% accuracy. The results were published in Investigative...