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1:23 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Non-profit gets PRV, FDA approval for river blindness drug

Medicines Development for Global Health (Southbank, Australia) said FDA approved its NDA for moxidectin to treat onchocerciasis, commonly known as river blindness, in patients at least 12 years old. MDGH received a Priority Review voucher...
1:23 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA wants more info on scPharmaceuticals' Furoscix

scPharmaceuticals Inc. (NASDAQ:SCPH) received a complete response letter on June 13 from FDA to an NDA for Furoscix (scFurosemide) to treat edema in patients with heart failure. scPharmaceuticals said the letter indicated that additional human factors...
1:23 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Tagrisso for NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said the European Commission approved Tagrisso osimertinib as a first-line treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations. The approval was based...
1:22 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Chinese approval for Ascletis' HCV drug

Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said China's State Drug Administration approved an NDA for Ganovo danoprevir to treat HCV. The company intends to launch the product next quarter, according to its website. Ascletis said...
1:22 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Lilly planning Phase III trials for Olumiant in lupus

Eli Lilly and Co. (NYSE:LLY) said it plans to start this year Phase III testing of Olumiant baricitinib to treat systemic lupus erythematosus (SLE) after reporting that the higher dose of the drug met the...
1:22 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Elios' dendritic cell vaccine leads to no significant difference in recurrence in Phase IIb for melanoma

Elios Therapeutics LLC (Austin, Texas) reported interim data from 120 patients with stage III or IV resected melanoma in a Phase IIb trial showing that the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine led to...
1:21 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Vical discontinuing HSV-2 program after Phase II miss

Vical Inc. (NASDAQ:VICL) said it will discontinue development of VCL-HB01 after the HSV-2 vaccine missed the primary endpoint in a Phase II trial. VCL-HB01 is a plasmid DNA vaccine that encodes the HSV-2 glycoprotein D and...
1:15 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Nektar seeks U.S. approval for analgesic opioid molecule

Nektar Therapeutics (NASDAQ:NKTR) said it submitted an NDA to FDA for NKTR-181, an analgesic opioid molecule. Nektar said NKTR-181 is designed to have low blood brain barrier permeability to slow its rate of entry and...
1:15 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Sunovion's PD therapy NDA gets PDUFA date

Sunovion Pharmaceuticals Inc. said FDA accepted an NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson's disease (PD). The PDUFA date is Jan. 29, 2019. Sunovion, a unit of Sumitomo Dainippon Pharma Co....
1:14 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Eisai, Purdue's insomnia candidate does not impair driving in Phase I

Eisai Co. Ltd. (Tokyo:4523) and Purdue Pharma L.P. (Stamford, Conn.) reported top-line data from the Phase I Study 106 showing that insomnia candidate lemborexant (E2006) given each night at bedtime met the primary endpoint of...

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