• Government makes new rule for clinical trial after consultation with the Drugs Technical Advisory Board that an audio - video recording of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

  • (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.

  • 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.

    [adsense:336x280:8701650588]

  • 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).

  • 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.

  • (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).

  • (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.

Subscribe to CR News