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12:32 PM, Sep 14, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Celltrion NDA for rituxan biosimilar awaits FDA panel discussion

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
10:25 AM, Sep 14, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Oct. 11 advisory committee meeting for Trevena's pain candidate

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 11 to discuss an NDA for Olinvo oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) for the management of moderate to severe acute pain in adult...
3:43 PM, Sep 13, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil sublingual tablet (ARX-04) to manage moderate to severe acute pain severe...
3:42 PM, Sep 13, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA needs more data to support GSK's Nucala for COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a complete response letter from FDA to an sBLA for Nucala mepolizumab to treat chronic obstructive pulmonary disease. According to the pharma, the agency said more clinical data are required...
12:35 PM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Merck's doravirine HIV therapies

Merck & Co. Inc. (NYSE:MRK) said FDA approved two doravirine-based therapies to treat HIV infection ahead of their Oct. 23 PDUFA date: once-daily Pifeltro doravirine for use in combination with antiretrovirals; and once-daily Delstrigo, a...
11:44 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Puma's Nerlynx as adjuvant for breast cancer

The European Commission approved Nerlynx neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for extended adjuvant treatment of adults with early hormone receptor-positive, HER2-overexpressed/amplified breast cancer within one year of completion of prior adjuvant Herceptin trastuzumab-based therapy....
11:40 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Setback for Sunovion's dasotraline in ADHD

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said it received a complete response letter for dasotraline (SEP-225289) to treat ADHD. The company said FDA indicated the need for more efficacy...
11:31 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Chinese regulators reviewing pair of BeiGene therapies

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said Aug. 31 that China's National Medical Products Administration accepted an NDA for anti-PD-1 mAb tislelizumab (BGB-A317) to treat relapsed or refractory classical Hodgkin lymphoma (cHL). The news follows BeiGene's Aug. 26...
11:30 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Sanofi's Cablivi gains EU approval, Priority Review in U.S.

Sanofi (Euronext:SAN; NYSE:SNY) said the European Commission approved Cablivi caplacizumab to treat rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). The company also revealed Sept. 3 that FDA accepted and granted Priority Review to...
11:17 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

ChiMed scores a China first with fruquitinib approval

Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said China's National Medical Products Administration (NMPA) approved Elunate fruquintinib to treat metastatic colorectal cancer (mCRC). According to Chi-Med, the drug is the first China-discovered and developed product for...

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