Roche Submits IND For Phase 2 Clinical Trial Of Erivedge In Lung Disease
Curis, an oncology-focused biotechnology company developing novel drug candidates for cancer treatment, today announced that Roche filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a multicenter, Phase 2 clinical study of Erivedge (vismodegib) in patients who suffer from the debilitating lung disease idiopathic pulmonary fibrosis (IPF). (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 25, 2014 Category: Pharmaceuticals Source Type: news
AZTherapies gets FDA nod to initiate Phase III trial of ALZT-OP1 to treat Alzheimer's disease
US-based AZTherapies has received clearance from the US Food and Drug Administration (FDA) to proceed with the Phase III clinical trial submitted in its investigational new drug (IND) application. (Source: Drug Development Technology)
Source: Drug Development Technology - May 26, 2014 Category: Pharmaceuticals Source Type: news
GW Pharma gets FDA approval for Phase II/III trial of Epidiolex to treat Dravet Syndrome
British biopharmaceutical firm GW Pharmaceuticals has received confirmation from the US Food and Drug Administration (FDA) that its investigational new drug application (IND) is now open for Epidiolex in the treatment of Dravet dyndrome, also known a… (Source: Drug Development Technology)
Source: Drug Development Technology - May 8, 2014 Category: Pharmaceuticals Source Type: news
JDP Receives U.S. FDA Clearance for Phase 3 Clinical Trial of JDP-205...
JDP Therapeutics Inc., a privately held specialty pharmaceutical company, is pleased to announce that the Company’s Investigational New Drug (IND) to conduct an initial Phase 3 clinical trial of...(PRWeb March 13, 2014)Read the full story at http://www.prweb.com/releases/2014/03/prweb11666234.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 13, 2014 Category: Pharmaceuticals Source Type: news
C3 Jian begins Phase II study of anti-cavity drug C16G2
C3 Jian has initiated the first Phase II clinical study for its C16G2, which selectively targets a cavity-causing organism Streptococcus mutans, under its US Food and Drug Administration investigational new drug (IND) application. (Source: Drug Development Technology)
Source: Drug Development Technology - March 11, 2014 Category: Pharmaceuticals Source Type: news
Ignyta files IND application with FDA for tumour drug RXDX-101
Ignyta has filed an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for its RXDX-101, an oral tyrosine kinase inhibitor targeting solid tumour indications. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 3, 2014 Category: Pharmaceuticals Source Type: news
Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.
(Source: What's New at CBER)
Source: What's New at CBER - February 26, 2014 Category: Biomedical Science Source Type: news
FDA Accepts Regado Biosciences' Application For REG2
Regado Biosciences, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for REG2 for venous thrombosis. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - February 25, 2014 Category: Pharmaceuticals Source Type: news
FDA Reviewers Deliver Split Opinion On New Heart Drug From The Medicines Company
FDA reviewers presented two dramatically different views of The Medicines Company's investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials "were conducted unethically" and should not be approved "on that fact alone." But two other reviewers recommend approval. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - February 10, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Alcobra seeks FDA's IND approval for Metadoxine extended-release to treat ADHD
Israeli biopharmaceutical company Alcobra has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase III clinical trial with its proprietary drug candidate MG01CI (Metadoxine extended-release… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 10, 2014 Category: Pharmaceuticals Source Type: news
FDA grants approval of a Phase 3 pivotal study for ST10 for the treatment of iron deficiency anaemia in chronic kidney disease
Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - December 18, 2013 Category: Consumer Health News Tags: Urology / Nephrology Source Type: news
With new multimillion-dollar grants, UCLA scientists take stem cell research to patients
Scientists from UCLA are now bringing their groundbreaking stem cell science directly to patients in two exciting new clinical trials scheduled to begin in early 2014, thanks to funding from California's stem cell agency.
The new grants to researchers at UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, which total nearly $21 million, were announced Dec. 12 at a meeting of the California Institute of Regenerative Medicine (CIRM) Citizen's Oversight Committee. They are apart of the state agency's Disease Team Therapy Development III initiative.
A team led by UCLA's Dr. Denni...
Source: UCLA Newsroom: Health Sciences - December 16, 2013 Category: Universities & Medical Training Source Type: news
Shield Therapeutics submits IND application for Phase III trial of iron-replacement therapy
Shield Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to begin a Phase III trial of its novel oral ferric iron-replacement therapy ST10 for the treatment of iron deficiency anaemi… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - November 14, 2013 Category: Pharmaceuticals Source Type: news
Allegro gets FDA approval to start two Phase II trials of integrin peptide therapy
The US Food and Drug Administration (FDA) has approved Allegro Ophthalmics' investigational new drug (IND) application to start two Phase II clinical trials of ALG-1001, a first in class integrin peptide therapy. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 9, 2013 Category: Pharmaceuticals Source Type: news
US FDA accepts Ligand's IND application for diabetes drug
Ligand Pharmaceuticals has received US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for glucagon receptor antagonist programme, and will start clinical development of LGD-6972 for the treatment of typ… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 7, 2013 Category: Pharmaceuticals Source Type: news
