News

FDA issues Complete Response Letters for elvitegravir and cobicistat (Gilead Sciences)

Gilead Sciences, Inc. has announced that the company has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

In its communications,the FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in ...

CHMP recommends Stribild (Gilead Sciences) for the treatment of HIV

Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of ...

RTS,S Malaria Vaccine (GSK) disappoints

The effectiveness of a Malaria Vaccine, RTS,S, developed by GlaxoSmithKline wanes over time, with the shot protecting only 16.8 percent of children over four years, according to trial data. The disappointing results for RTS,S - the world's first potential malaria vaccine - raise further questions about whether it can make a difference in the fight against the disease, a major ...

Phase III SAILING study of dolutegravir(ViiV) success in HIV-1

ViiV Healthcare has announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor.

At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c/mL) vs. ...

RTS.S anti malaria vaccine further results in African study

Results from a pivotal, large-scale Phase III trial, published online in the New England Journal of Medicine, show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and ...

Sanofi Pasteur Dengue vaccine success in clinical trial

Sanofi Pasteur, the vaccines division of Sanofi announced that its tetravalent Dengue Vaccine candidate demonstrated proof of efficacy against Dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of ...

Ranbaxy launches Indias first new drug Synriam for Malaria

Ranbaxy Laboratories Limited has launched India’s first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults.The new drug, has been approved by the Drug Controller General of India (DCGI) for marketing in India and conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most ...

Phase II study underway of Shok-Pak (Inflammagen Therapeutics) for patients with Shock

A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics, as a potential treatment for critically ill patients suffering from Multiple Organ Dysfunction Syndrome (MODS), formally known as multiple organ failure. Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding. ...

CHMP positive for Pyramax(Shin Poong Pharma) a new treatment for Malaria

The CHMP has recommended Pyramax, a fixed combination consisting of pyronaridine and artesunate, an artemisinin derivative, from Shin Poong Pharmaceutical Co, for use outside the European Union for Malaria. The CHMP opinion is intended to support registrations in countries outside the EU where there is reported artemisinin resistance. Parasitic resistance to artemisinin as well as partner drugs is on the ...

RTS,S anti malaria vaccine success in large African study

RTS,S, a new experimental vaccine from GlaxoSmithKline, with research funded in part through grants from the Bill & Melinda Gates Foundation, has been shown in interim Phase III results to significantly reduce the incidence of both clinical and severe malaria in African children. In a study of 15 410 children in Africa RTS, S RTS,S reduced the incidence of clinical ...