Clinical Intelligence

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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Adheris Health, Behavioral Insights Group launch ethnographic study

Thursday, October 23, 2014 01:51 PM

Adheris Health, an inVentiv Health company and a provider of medication adherence programs, has announced the start of the next phase of an ethnographic study into how Americans make healthcare decisions and the role of American culture in influencing health behaviors.

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Immatics, BioNTech advance personalized cancer vaccines into clinical trials

Thursday, October 16, 2014 12:00 PM

BioNTech and immatics biotechnologies are moving a novel concept of fully personalized therapeutic cancer vaccines, Glioma Actively Personalized VAccine Consortium (GAPVAC), into the clinic. The German national authority, the Paul-Ehrlich-Institute (PEI), has approved the start of a phase I/II study, GAPVAC-101, which applies for the first time the concept of treating glioblastoma patients based on drugs designed and manufactured for each patient individually according to specific characteristics of their tumor and immune system.

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January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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