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10:00 AM, Mar 20, 2018  |  BC Extra | Politics & Policy

FDA, Kaiser evaluating PROs in pancreatic cancer patients

FDA launched a study to explore patient-reported outcomes in patients with newly diagnosed pancreatic cancer. The agency's Office of Hematology and Oncology Products partnered with Kaiser Foundation Research Institute to conduct the prospective natural history...
10:06 PM, Mar 19, 2018  |  BC Extra | Preclinical News

Rhythm estimates mutations in genes tied to obesity

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) presented an analysis of genetic epidemiology data at the Endocrine Society meeting in Chicago suggesting that about 12,800 Americans are homozygous or compound heterozygous for known and predicted loss-of-function variants in...
5:19 PM, Mar 19, 2018  |  BC Extra | Company News

MPs call on U.K. government to resolve Orkambi impasse

Members of Parliament called on the U.K. government on Monday to resolve an impasse that has stalled reimbursement discussions between Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and NHS England over the price of Orkambi lumacaftor/ivacaftor. The move...
4:51 PM, Mar 19, 2018  |  BC Innovations | Translation in Brief

Crafting CAR Tregs

TxCell S.A. (Euronext:TXCL) thinks it has cracked the code on building CAR Tregs without running into the manufacturing challenges that can compromise the cells’ immunosuppressive function. The company presented data on their manufacturing process at...
4:43 PM, Mar 19, 2018  |  BC Extra | Politics & Policy

Trump vows plan to reduce drug prices

President Donald Trump and HHS Secretary Alex Azar said on Monday that the White House will soon release proposals that seek to lower prescription drug prices. Azar said that the administration will release “in about a...
3:39 PM, Mar 19, 2018  |  BC Extra | Politics & Policy

FDA shares data from first drug in transparency pilot

As part of its clinical data transparency pilot program, FDA posted on Monday a clinical study report for Erleada apalutamide from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). The report contains extensive...
2:47 PM, Mar 19, 2018  |  BC Extra | Company News

Management tracks: J&J, Alder, CVS

Johnson & Johnson (NYSE:JNJ) said EVP and CFO Dominic Caruso will retire in September. He is succeeded by VP of investor relations Joseph Wolk. Alder BioPharmaceuticals Inc. (NASDAQ:ALDR) said President and CEO Randall Schatzman will step...
2:31 PM, Mar 19, 2018  |  BC Extra | Clinical News

Eylea clears first Phase III hurdle in diabetic retinopathy subset

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said Eylea aflibercept met the first of two primary endpoints in the Phase III PANORAMA trial to treat non-proliferative diabetic retinopathy without diabetic macular edema (DME). The company plans to submit...
2:30 PM, Mar 19, 2018  |  BC Extra | Politics & Policy

Revising patent law among State Council legislative priorities

China's State Council released a circular on March 14 broadly outlining legislative projects for 2018, including revision of the country’s patent law. The projects also include draft legislation on foreign investment and management of human...
1:49 PM, Mar 19, 2018  |  BC Extra | Clinical News

Arena's S1PR1 agonist meets in Phase II for UC

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) said high-dose etrasimod (APD334) met the primary and secondary endpoints in the Phase II OASIS trial to treat ulcerative colitis. The company, which announced the news after market hours on Monday,...