CR News

- Read more about First interim results from Ebola vaccine efficacy trial suggest vaccine provides high protection against disease
Tests of the experimental Ebola vaccine VSV-ZEBOV in over 7500 participants in Guinea suggest that the vaccine provides high protection against the disease as early as ten days after vaccination, in adults who have potentially been exposed to the virus by coming in close contact with a recently infected person.
- Read more about Biocon's CRO arm Syngene seeks approval for IPO, files DRHP; offer allows Biocon to monetize its shareholding in Syngene
(Business Wire India); Biocon Ltd, Asia's premier biopharmaceuticals company, today announced that its Contract Research subsidiary Syngene International Ltd (“Syngene”) has filed the Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) on April 22, 2015, seeking approval for an Initial Public Offering (IPO). This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5% equity stake in Syngene.
- Read more about Novartis presents Cosentyx™ two-year efficacy and safety data showing sustainable effect in psoriasis patients
Novartis today announced new two-year results demonstrating sustained efficacy with Cosentyx™ (secukinumab) with an acceptable safety profile for the treatment of psoriasis patients. The data comes from the extension study of the pivotal Phase III FIXTURE and ERASURE trials. Results were presented for the first time in a late-breaking session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco. Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved to treat adult moderate-to-severe plaque psoriasis patients.

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- Read more about New clinical trials to evaluate long-acting, injectable antiretroviral drugs to prevent HIV
Two new clinical trials are examining the safety and acceptability of antiretroviral medicines administered via injection as a means of protecting against HIV infection. The studies are being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and conducted by the NIAID-funded HIV Prevention Trials Network (HPTN).
- Read more about Action taken by CDSCO against misuse and unethical stem cell clinical trial malpractices at hospital
Central Drugs Standard Control Organization (CDSCO) investigated a Pune based hospital after receiving compliant against hospital that they are performing unethical stem cell clinical trial and patients are highly charged for unapproved and illegal transplants.
- Read more about GSK's Ebola Vaccine appears safe and shown encouraging immune response
An experimental vaccine to prevent Ebola virus disease was well-tolerated and produced immune system responses in all 20 healthy adults who received it in a phase 1 clinical trial conducted by researchers from the National Institutes of Health. The candidate vaccine, which was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK), was tested at the NIH Clinical Center in Bethesda, Maryland. The interim results are reported online in advance of print in the New England Journal of Medicine.
- Read more about Psoriasis Drug of Amgen and AstraZeneca conquered blockbuster Stelara
(12th November, 2014); Brodalumab, a novel psoriasis drug from colloboration of Amgen and Astrazeneca shown superior results in compare to Stelara® (ustekinumab) in head to head trials. The trial conducated on moderate-to-severe plaque psoriasis which met its primary endpoints when compared with both Stelara and placebo at week 12. Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100).
- Read more about Health Ministry : Now Clinical Trials will be evaluated on parameters given by Supreme Court
(12th September, 2014); Now in India, all the Global Clinical Trials (GCTs)/New Clinical Trials (NCEs) should be evaluated on regard to parameters given by Honorable supreme court. Drugs controller general of India (DCGI) clearly mentioned on all parameters in their notice.
- Read more about Angiotensin receptor-neprilysin inhibitor opens new horizon in cardiac failure
(3rd September, 2014); The new agent, an angiotensin receptor-neprilysin inhibitor (ARNI) known as LCZ696, has already been granted Fast Track status by the United States Food and Drug Administration (FDA) – a designation which can expedite the review of new medicines intended to treat serious or life-threatening conditions. And surprisingly, LCZ696 was superior to ACE-inhibitor, enalapril, on key endpoints in the largest heart failure study ever done.
- Read more about GSK and NIAID initiates First Human Trial for Ebola Vaccine
Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin soon by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.