FDA

Butrans Transdermal System CIII receives FDA approval for new dosage strength

Wednesday, July 23, 2014 08:00 AM

Purdue Pharma has announced that the FDA approved a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans now will be available: 5mcg/hour, 7.5mcg/hour, 10mcg/hour, 15mcg/hour and 20mcg/hour. The Butrans Transdermal System also is approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20mcg/hour. Purdue expects to launch Butrans 7.5mcg/hour commercially in the U.S. in October 2014.

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WIRB Copernicus Group

Ruthigen treats first human subjects in clinical trial for RUT58-60

Tuesday, July 22, 2014 08:00 AM

Ruthigen, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, has treated the first human subjects with its drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August.

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CRF Health eCOA webinar series

Dipexium Pharmaceuticals initiates phase III trial for diabetic foot ulcer infections

Monday, July 21, 2014 08:00 AM

Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal phase III clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI.

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Pfizer to acquire InnoPharma

Thursday, July 17, 2014 12:48 PM

Pfizer has entered an agreement to acquire InnoPharma, a privately held pharmaceutical development company, for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.

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Factory-CRO launches clinical trial rescue program for medical devices

Wednesday, July 16, 2014 01:17 PM

Factory-CRO, a medical device CRO based in the Netherlands, has announced a new early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by the FDA or European regulators.

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FDA approves IDE for VENITI VICI Venous Stent System

Monday, July 14, 2014 01:33 PM

Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.

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Baxter acquires AesRx

Thursday, July 10, 2014 12:51 PM

Baxter International has acquired AesRx, a private U.S. biopharmaceutical company focused on orphan drug targets, including the development and commercialization of Aes-103, an investigational prophylactic treatment for sickle cell disease (SCD).

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Portola, Daiichi Sankyo to collaborate on andexanet alfa study

Wednesday, July 9, 2014 12:01 PM

Portola Pharmaceuticals has entered into a second clinical collaboration agreement with Daiichi Sankyo to study andexanet alfa, Portola's investigational Factor Xa inhibitor antidote, in phase III registration studies with Daiichi Sankyo's Factor Xa inhibitor edoxaban. Portola's original collaboration agreement with Daiichi Sankyo, announced in June 2013, covered the conduct of a phase II proof-of-concept study, for which results are anticipated later this year.

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Actavis completes acquisition of Furiex Pharmaceuticals

Friday, July 4, 2014 08:00 AM

Forest Laboratories, a subsidiary of Actavis, has successfully completed its acquisition of Furiex Pharmaceuticals in an all-cash transaction valued at approximately $1.1 billion, and up to approximately $360 million in a Contingent Value Right (CVR) that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval.

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Amgen receives FDA Breakthrough Therapy Designation for Blinatumomab in ALL

Wednesday, July 2, 2014 11:04 AM

The FDA has granted Breakthrough Therapy Designation to Amgen’s investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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CWWeekly

July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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The CenterWatch Monthly

June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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