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1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Alexion submits BLA for long-acting C5 inhibitor for PNH

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) submitted a BLA to FDA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) using a rare disease Priority Review voucher. The submission is based on data from the Phase III ALXN1210-PNH-301 and...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Suboxone generics from Mylan, Dr. Reddy

FDA approved two generic buprenorphine/naloxone sublingual film products from Mylan N.V. (NASDAQ:MYL) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY), respectively, to treat opioid dependence. FDA said they are the first approved generic versions of Suboxone sublingual...
12:02 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA restricts Keytruda, Tecentriq monotherapy

FDA restricted the labels of Keytruda pembrolizumab and Tecentriq atezolizumab as monotherapy for urothelial cancer in a first-line setting. The update applies to Keytruda or Tecentriq's use in locally advanced or metastatic urothelial carcinoma to patients...
11:27 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA lifts clinical hold on Solid's DMD gene therapy

Solid Biosciences Inc. (NASDAQ:SLDB) said FDA lifted a clinical hold on the Phase I/II IGNITE DMD trial of microdystrophin gene transfer therapy SGT-001 to treat Duchenne muscular dystrophy (DMD). Solid plans to resume enrollment under...
10:58 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA places hold on upcoming Phase I for point-of-care CAR Ts

FDA placed a clinical hold on an upcoming Phase I trial sponsored by Ziopharm Oncology Inc. (NASDAQ:ZIOP), which would be the first for its third-generation, point-of-care CAR T cells that require two days for manufacturing....
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Medivir delays remetinostat Phase III

Medivir AB (SSE:MVIR B) lost SEK4.60 (12%) to SEK34.05 on June 18 after announcing it will delay to 2019 the start of a Phase III trial of remetinostat in early stage cutaneous T-cell lymphoma (CTCL)....
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

BMS first to cross finish line in China PD-1 approval race

The State Drug Administration approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), marking China’s first approval of an immuno-oncology agent, according to the pharma. The anti-PD-1 mAb is indicated to treat locally advanced or metastatic...
10:57 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA panel to review Paratek antibiotic

FDA's Antimicrobial Drugs Advisory Committee scheduled an Aug. 8 meeting to discuss two NDAs for omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK). The agency is reviewing oral and IV versions of the amniomethylcycline antibiotic to treat community-acquired...
10:56 AM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Valeant receives complete response letter for psoriasis candidate

The Ortho Dermatologics unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said it received a complete response letter from FDA to an NDA for Duobrii (IDP-118) to treat plaque psoriasis. According to Valeant, FDA had questions...
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...

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