Clinical Intelligence

FDA approves sNDAs for Invega Sustenna for schizoaffective disorder

Thursday, November 13, 2014 02:22 PM

The FDA has approved Janssen Pharmaceutical's supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under Priority Review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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Quest Diagnostics

Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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Leading BioSciences submits compassionate use IND for Ebola-related shock

Friday, November 7, 2014 01:03 PM

Leading BioSciences, a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock, has submitted an expanded access Investigational New Drug application (IND) with the FDA— also known as "compassionate use"—for its lead product LB1148.

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FDA issues response letter for Aeterna Zentaris' Macrilen NDA

Friday, November 7, 2014 12:58 PM

Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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The CenterWatch Monthly, November 2014

Monday, November 3, 2014 08:12 AM

Private equity fueling CRO growth, expansion

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Synageva BioPharma reports positive results from LAL Deficiency study

Monday, October 27, 2014 01:46 PM

Synageva BioPharma, a biopharmaceutical company developing therapeutic products for rare disorders, has announced results of sebelipase alfa for LAL Deficiency in two different trials.

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Burzynski Research Institute to launch diffuse intrinsic brainstem glioma trial

Monday, October 27, 2014 01:38 PM

Burzynski Research Institute (BRI) has announced that the FDA has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients >3 months of age with a diffuse intrinsic brainstem glioma (DIPG).

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FDA approves new treatment for rare form of hemophilia

Monday, October 27, 2014 01:24 PM

The FDA has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

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Xiaflex approved for concurrent treatment in Dupuytren's contracture patients

Friday, October 24, 2014 12:48 PM

Auxilium Pharmaceuticals has announced that the FDA has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.

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TWi Biotechnology receives Orphan Drug designation for AC-201

Thursday, October 23, 2014 03:29 PM

TWi Biotechnology has received the designation of Orphan Drug from the FDA for using AC-201 to treat epidermolysis bullosa (EB). TWi Biotechnology has developed proprietary formulations to be used topically for the indication of EB.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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