BioCentury | Apr 25, 2019
Politics & Policy

Pew's Jungman to lead FDA CDER oversight office

FDA's Center for Drug Evaluation and Research hired Elizabeth Jungman as director of the Office of Regulatory Policy, beginning in July. CDER Director Janet Woodcock announced Jungman's appointment in an email to staff Thursday. The...
BioCentury | May 24, 2017
Financial News

OrphoMed raises $39M in series A

Gastrointestinal company OrphoMed Inc. (Mill Valley, Calif.) said it raised $39 million in a series A round co-led by New Enterprise Associates (NEA) and existing investor Takeda Ventures. Existing investors Pappas Capital, Relativity Healthcare Partners...
BioCentury | Feb 28, 2017
Distillery Therapeutics

Cardiovascular

INDICATION: Hypertension Mouse studies suggest thioredoxin could help treat age-related hypertension. In a mouse model of age-related hypertension, human thioredoxin or systemic expression of human thioredoxin decreased blood pressure and aortic stiffness and increased endothelium-dependent...
BioCentury | Jan 18, 2017
Distillery Therapeutics

Infectious disease

...INDICATION: Malaria Mosquito and mouse studies suggest inhibiting Plasmodium ORP1 or ORP2 could help treat malaria...
...of ORP1 or ORP2 decreased mosquito transmission of P. berghei to mice compared with normal ORP1...
...animals. Next steps could include identifying and testing inhibitors of Plasmodium ORP1 or ORP2. TARGET/MARKER/PATHWAY: Plasmodium oocyst rupture protein 1 (ORP1)...
BioCentury | Oct 13, 2016
Distillery Therapeutics

Therapeutics: Oxysterol binding protein 2 (OSBP2; ORP4)

Cancer INDICATION: Acute lymphoblastic leukemia (ALL) Cell culture and mouse studies suggest inhibiting OSBP2 could help treat T cell ALL. In a human T cell ALL cell line, shRNA targeting OSBP2 decreased survival compared with...
BioCentury | Feb 12, 2015
Distillery Therapeutics

Therapeutics: Oxysterol binding protein (OSBP); oxysterol binding protein 2 (OSBP2; ORP4)

Infectious disease INDICATION: Viral infection In vitro studies suggest the generic antifungal drug itraconazole could help treat picornaviral and hepatitis C viral (HCV) infection. In human cells infected with a panel of enteroviruses and other...
BioCentury | Sep 16, 2014
Politics & Policy

Sipes named director of CDER's Office of Regulatory Policy

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced in an internal memo that the agency hired Grail Sipes as director of CDER's Office of Regulatory Policy (ORP), effective Sept. 22. Prior...
BioCentury | Dec 20, 2012
Politics & Policy

ORP Director to become senior advisor with compounding focus

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in an internal memo that Jane Axelrad, director of the Office of Regulatory Policy (ORP), will become a senior advisor to Woodcock, effective...
BioCentury | Aug 6, 2012
Company News

OrPro pulmonary, drug delivery news

Newco OrPro made its public debut with the receipt of a Small Business Innovation Research (SBIR) grant from NIH to develop an inhaled formulation of OrPro's preclinical product ORP-100 for cystic fibrosis. The grant amount...
BioCentury | Aug 1, 2012
Company News

OrPro makes public debut with NIH grant for CF

Newco OrPro Therapeutics Inc. (San Diego, Calif.) made its public debut with the receipt of a Small Business Innovation Research (SBIR) grant from NIH to develop an inhaled formulation of OrPro's ORP-100 for cystic fibrosis....
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