Clinical Intelligence

Melinta’s Baxdela releases positive phase III results for hospital-treated skin infections

Friday, May 13, 2016

Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, today announced top-line results from the second phase III study (RX-3341-303 NCT01984684) of Baxdela (delafloxacin), an investigational anionic quinolone in development for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).

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FDA grants Priority Review for Lilly’s Olaratumab

Monday, May 9, 2016

The FDA has granted Priority Review for the biologics license application (BLA) for Eli Lilly’s olaratumab, a PDGFRα antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

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The CenterWatch Weekly, May 2, 2016

Monday, May 2, 2016

IRBs react to new model for registering proposed gene trials

On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjust­ing quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.

 

Clinical research in India: Despite setbacks, opportunity continues

India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blem­ishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future. The latest setback came in April from the World Health Organization (WHO), which sent a notice of concern to the Indian CRO Semler Research, alleging data manipulation in a number of bioanalytical studies uncovered during site visits in December and January. WHO said its findings question the validity of studies performed for 12 products and that companies including Mylan, Lupin, Micro Labs and others may need to repeat trials conducted by the CRO.

 

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The CenterWatch Monthly, May 2016

Monday, May 2, 2016

Sites smothered by technology solutions

Technology solutions help sponsors and CROs make better drug develop­ment decisions, streamline processes and reduce clinical trial costs. But for a majority of investigative sites, these same technologies get in the way of efficient op­erations and add to their already heavy workload. CenterWatch analysis suggests that in­vestigative sites are inundated with a grow­ing number of technologies that rarely in­teract with each other. Only 9% of global investigative sites surveyed report that technology solutions provided by sponsors and CROs to conduct clinical studies meet their operating needs “very well.”

Capture

Welcoming procurement onto the team

For decades, procurement profession­als have been the Rodney Danger­fields of the pharmaceutical industry: they got no respect. Procurement held up projects, got bogged down in protracted budget and contract negotiations, and was a hassle. The function is now changing. Pro­curement is moving from the back room to front and center. Searching for new ways to improve the effectiveness of their collaborations with CROs and investigative sites, sponsor companies are looking at the procure­ment function as a more strategic rela­tionship-driving asset. The role of pro­curement professionals is evolving from one focused almost exclusively on cost-savings and transactional activities to one focused more strategically on facilitating collaboration, innovation and efficiency.

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Inovio, NIH, Mayo to initiate hepatitis C immunotherapy trial

Thursday, April 28, 2016

Inovio Pharmaceuticals has announced that its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies.

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