Clinical Intelligence

The CenterWatch Monthly, March 2015

Monday, March 2, 2015 08:00 AM

Novo Nordisk, Takeda, ServierCelgene among top sponsors

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Quest Diagnostics

FDA approves new antibacterial drug Avycaz

Thursday, February 26, 2015 01:12 PM

The FDA has approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

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Palatin launches web site in support of phase III program for female sexual dysfunction

Thursday, February 26, 2015 12:15 PM

Palatin Technologies, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, has launched a clinical trial web site (https://www.reconnectstudy.com) in support of its phase III reconnect study with bremelanotide for the treatment of female sexual dysfunction (FSD).

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Omeros's phase II OMS721 trial completes dosing, extended access for compassionate use

Thursday, February 26, 2015 10:45 AM

Omeros has completed dosing of the low-dose cohort of patients in its ongoing phase II clinical trial evaluating the efficacy and safety of OMS721, the lead human monoclonal antibody for its mannan-binding lectin-associated serine protease-2 (MASP-2) program, in treating thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.

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Collegium Pharmaceutical files NDA with FDA for Xtampza ER

Thursday, February 19, 2015 01:15 PM

The FDA has accepted for filing Collegium Pharmaceutical’s NDA for Xtampza ER, its novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain. Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development and commercialization of innovative abuse-deterrent treatments for chronic pain and other diseases

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FDA grants Genentech’s cobimetinib Priority Review for melanoma

Thursday, February 19, 2015 01:00 PM

The FDA has accepted and granted Priority Review for Genentech’s, a member of the Roche Group, NDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by Aug. 11.

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NIH trial compares three drugs for diabetic macular edema

Thursday, February 19, 2015 12:49 PM

In an NIH-supported clinical trial comparing three drugs for diabetic macular edema (DME), Eylea (aflibercept) provided greater visual improvement, on average, than did Avastin (bevacizumab) or Lucentis (ranibizumab) when vision was 20/50 or worse at the start of the trial. However, the three drugs resulted in similar average improvement when starting vision was 20/40 to 20/32. Investigators found no major differences in the safety of the three drugs. The trial was funded by the National Eye Institute (NEI), part of the NIH.

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Apellis enters clinical testing in age-related macular degeneration program

Wednesday, February 11, 2015 03:36 PM

Apellis Pharmaceuticals has begun the phase I clinical trial of its drug compound APL-2 in patients suffering from age-related macular degeneration (AMD).

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Advanced Inhalation Therapies receives Orphan Drug designation Cystic Fibrosis treatment

Wednesday, February 11, 2015 03:04 PM

The FDA has granted Orphan Drug designation to AIT-CF, Advanced Inhalation Therapies' (AIT) proprietary high dose formulation of nitric oxide (NO) for adjunctive treatment of cystic fibrosis (CF). In the U.S., Orphan Drug designation provides a variety of incentives, including seven years of market exclusivity, should AIT-CF receive FDA approval.

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Baxter presents positive data from pivotal study of BAX 855 for hemophilia A

Wednesday, February 11, 2015 02:58 PM

Baxter International has presented additional efficacy and safety data from the phase III pivotal study of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

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CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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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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