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49943 items
2:03 PM, Feb 14, 2018  |  BC Extra | Politics & Policy

Study: U.S. prescription drug spending to accelerate

A report by CMS’s Office of the Actuary predicts average spending growth of prescription drugs will outpace most large health care goods and services, averaging 6.3% growth per year for the next decade. The expected faster...
1:58 PM, Feb 14, 2018  |  BC Extra | Company News

Aradigm execs resign weeks after CRL

Aradigm Corp. (NASDAQ:ARDM) said President and CEO Igor Gonda, CMO Juergen Froehlich and CFO and VP of Finance Nancy Pecota resigned on Feb. 11, according to an SEC filing. The company named Chairman John Siebert as...
1:44 PM, Feb 14, 2018  |  BC Extra | Company News

Viaskin Peanut data sufficient for BLA

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said Wednesday that FDA has agreed that the available safety and efficacy data for peanut allergy candidate Viaskin Peanut (DBV-712) will support a BLA submission for the product. DBV plans...
1:37 PM, Feb 14, 2018  |  BC Extra | Company News

J&J scores two firsts for Erleada approval

FDA approved an NDA for Erleada apalutamide (JNJ56021927) from Johnson & Johnson (NYSE:JNJ) to treat non-metastatic castration-resistant prostate cancer (CRPC), making it the first approved drug for the indication and the first approval based on...
12:07 PM, Feb 14, 2018  |  BC Extra | Company News

Vertex cancels CF trials in France

French cystic fibrosis patients may not receive access to treatments under development by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) after the company canceled French sites for three planned Phase III trials slated to evaluate combinations of the...
11:51 AM, Feb 14, 2018  |  BC Extra | Clinical News

Galmed falls on Phase IIa HIV-associated NAFLD miss

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) was down $4.01 (42%) to $5.45 on Wednesday after reporting that Aramchol arachidyl amino cholanoic acid missed the primary endpoint in the Phase IIa ARRIVE trial to treat HIV-associated lipodystrophy and...
4:23 PM, Feb 13, 2018  |  BC Extra | Clinical News

Kadmon falls after Phase II IPF data

Kadmon Holdings Inc. (NYSE:KDMN) fell $1.03 (21%) to $3.81 on Tuesday after reporting top-line data from the Phase II KD025-207 trial of KD025 to treat idiopathic pulmonary fibrosis in patients previously treated with or offered...
4:09 PM, Feb 13, 2018  |  BC Extra | Clinical News

Merck halts Phase III trial of AD candidate

Merck & Co. Inc. (NYSE:MRK) stopped the Phase III APECS trial of verubecestat (MK-8931) to treat prodromal Alzheimer’s disease after an external DMC said it was unlikely the trial would establish a positive benefit-risk profile...
4:08 PM, Feb 13, 2018  |  BC Extra | Politics & Policy

CFDA releases 2018 legislative plan

China FDA published a legislative road map for 2018 that outlines the agency’s plans to revise drug laws and regulations as well as develop guidance documents. Among the legislative projects in the 2018 plan, CFDA proposes...
2:56 PM, Feb 13, 2018  |  BC Extra | Politics & Policy

FDA outlines plans for $400M budget boost

FDA Commissioner Scott Gottlieb Tuesday released a statement outlining how the agency plans to spend the roughly $400 million FY19 budget increase the Trump administration has requested. The funds would be used to develop regulatory...