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Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

16 Dec 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

18 Nov 2013

Phase III EINSTEIN trial program: XARELTO reduces risk of DVT and PE

Janssen Pharmaceuticals, Inc. announced today a newly published, pooled analysis of the Phase III EINSTEIN trial program, showing XARELTO (rivaroxaban) is as effective as the standard of care in reducing the risk of deep vein thrombosis and pulmonary embolism in people with symptomatic DVT or PE, while reducing the incidence of major bleeding by 46 percent.

21 Sep 2013

Key HIV drug prices continue to fall, but newer medicines still priced too high

International medical humanitarian organisation Médecins Sans Frontières today released its annual report Untangling the Web of ARV Price Reductions,at the International AIDS Society conference in Kuala Lumpur.

3 Jul 2013

Study shows that PCCs can reverse blood thinning effects of XARELTO in healthy subjects

Janssen Research & Development, LLC announced today results of an open label, single-center, parallel group study showing that a type of medication called prothrombin complex concentrates can reverse the blood thinning effects of XARELTO (rivaroxaban) in healthy subjects.

2 Jul 2013

WHO's new HIV treatment guidelines call for immediate ART for HIV-infected children

The World Health Organization's new HIV treatment guidelines, released today at the 2013 International AIDS Society Conference, include new antiretroviral therapy recommendations for HIV-infected children, and will mean that more children will be on better treatments.

1 Jul 2013

Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC today announced the U.S. Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application for XARELTO (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

28 Jun 2013

Merck's LIPTRUZET tablets get FDA approval for treatment of elevated LDL cholesterol

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LIPTRUZET (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

4 May 2013

Indonesia to issue compulsory licenses for HIV, hepatitis B drugs still under patent

"The Indonesian government hopes to implement one of the largest ever examples of 'compulsory licensing,' which will enable the generic manufacture of drugs still under patent," IRIN reports.

27 Mar 2013

Discovery provides clues for potentially eliminating HIV infection in children

A two-year-old child born with HIV infection and treated with antiretroviral drugs beginning in the first days of life no longer has detectable levels of virus using conventional testing despite not taking HIV medication for 10 months, according to findings presented today at the Conference on Retroviruses and Opportunistic Infections in Atlanta.

5 Mar 2013

FDA approves 152 antiretroviral drugs in association with PEPFAR to treat HIV/AIDS

Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

24 Jul 2012

Researchers identify high ARV drug exposure in hair samples of HIV uninfected infants

Researchers from the University of California, San Francisco (UCSF) and Makerere University in Uganda have used hair and blood samples from three-month old infants born to HIV-positive mothers to measure the uninfected babies' exposure—both in the womb and from breast-feeding—to antiretroviral medications their mothers were taking. The results, they said, are surprising.

23 Jul 2012

Cipla, DNDi to develop ARV combination therapy for children with HIV/AIDS

On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.

21 Jul 2012

Gilead receives FDA approval for Truvada to reduce risk of sexually acquired HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

17 Jul 2012

JRD receives FDA priority review designation for XARELTO sNDAs to treat PE, DVT

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012 for XARELTO (rivaroxaban), an oral anticoagulant, seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.

9 Jul 2012

Janssen receives FDA complete response letter for XARELTO sNDA

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

22 Jun 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

ARV given to HIV-positive children boosts preventive power of key malaria drug, study shows

An antiretroviral (ARV) drug given to HIV-positive children "can boost the preventive power of a key malaria drug," according to a study conducted in Uganda and presented last week at the 19th Conference on Retroviruses and Opportunistic Infections, ScienceNow reports.

16 Mar 2012