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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...
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...
11:10 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...
10:53 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...
10:47 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Acacia provides update on plan to address PONV complete response letter

Acacia Pharma Group plc (Euronext:ACPH) said Oct. 15 that it will complete within one month a plan to address an undisclosed manufacturing deficiency identified by FDA that caused the agency to issue a complete response...
10:41 AM, Oct 19, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts resubmitted BLA for ADMA's RI-002

FDA accepted for review a resubmitted BLA from ADMA Biologics Inc. (NASDAQ:ADMA) for RI-002 to treat primary immune deficiency disease. The PDUFA date is April 2, 2019. In 2016, FDA issued a complete response letter to...
12:30 PM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Advisory panel narrowly rejects olicerideine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) to manage moderate to severe pain in adults for whom IV opioids are warranted. Panelists who...
10:34 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA, EMA to review Novartis' siponimod for secondary progressive MS

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and MAA have accepted applications for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS). The PDUFA date for the NDA is in March 2019; Novartis expects a decision...
10:32 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Leadiant therapy for ADA-SCID

Leadiant Biosciences Inc. said FDA approved Revcovi elapegademase-lvlr (EZN-2279) to treat pediatric and adult patients with adenosine deaminase severe combined immunodeficiency. Approval of the pegylated recombinant adenosine deaminase enzyme replacement therapy is based on two Phase...
10:30 AM, Oct 12, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 on Oct. 10 that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy...

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