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12:37 PM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel votes in favor of Shire’s constipation product

FDA’s Gastrointestinal Drugs Advisory committee voted unanimously in favor of approving an NDA from Shire plc (LSE:SHP; NASDAQ:SHPG) for prucalopride to treat chronic idiopathic constipation (CIC). Its PDUFA date is Dec. 21. The panel voted 10-0...
12:34 PM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

BioLineRx reports response, survival data for BL-8040, Keytruda combo in pancreatic cancer

BioLineRx Ltd. (Tel Aviv:BLRX; NASDAQ:BLRX) reported data from the Phase IIa COMBAT/KEYNOTE-202 trial showing that BL-8040 plus Keytruda pembrolizumab led to a disease control rate (DCR) of 34.5%, including one partial response and nine cases...
11:34 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Apellis pauses Phase III trials after single lot of APL-2 causes inflammation

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) voluntarily paused dosing in Phase III trials of intravitreal APL-2 to treat geographic atrophy due to eight reported cases of non-infectious inflammation in patients treated from a single manufacturing lot of...
11:25 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel votes in favor of AcelRx's pain candidate

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04) from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supports its approval to manage moderate to severe acute pain...
11:17 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Proteostasis' doublet CF therapy improves lung function in Phase I

Proteostasis Therapeutics Inc. (NASDAQ:PTI) reported that its doublet cystic fibrosis therapy improved percent predicted forced expiratory volume in 1 second (ppFEV1) and sweat chloride levels in a Phase I trial. The doublet therapy comprised CF...
11:13 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Keytruda, Inlyta combo headed for first-line RCC submissions

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab in combination with Inlyta axitinib met the primary endpoints vs. Sutent sunitinib in the Phase III KEYNOTE-426 trial as first-line treatment of renal cell carcinoma. Merck plans...
11:10 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

After three deals, FDA approval, talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
10:59 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Opdivo misses survival endpoint in Phase III for SCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Opdivo nivolumab missed the primary endpoint of improving overall survival (OS) in the Phase III CheckMate -331 trial to treat small cell lung cancer in patients who relapsed following platinum-based...
10:53 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Priority review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting. AbbVie said the...
10:49 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA OKs U.S. trial for Alphamab Oncology's HER2 bispecific antibody

Alphamab Oncology (Suzhou, China) said it received clearance from FDA to begin a U.S. Phase I trial of KN026, a HER2 bispecific antibody. Alphamab Oncology Chairman and CEO Ting Xu said in a statement that this...

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