Atazanavir News and Research

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Atazanavir, also known as Reyataz, is a type of medicine called a protease inhibitor (PI). PIs block protease, a protein that HIV needs to make more copies of itself. Atazanavir was approved by the FDA on June 20, 2003, for use with other antiretroviral medication in the treatment of HIV infection. This medicine does
not cure or prevent HIV infection or AIDS and
does not reduce the risk of passing the virus to
other people.

FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.

30 Jun 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.

6 Mar 2014

Amneal launches generic Esomeprazole strontium delayed-release capsules 49.3 mg

Amneal Pharmaceuticals LLC today announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. This new esomeprazole therapy is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium (esomeprazole magnesium) and presents a potentially more affordable treatment option for GERD in adult patients.

6 Jan 2014

Amneal's Esomeprazole Strontium 49.3 mg delayed-release capsules now available for GERD patients

Amneal Pharmaceuticals LLC today announced the launch of its branded Esomeprazole Strontium 49.3 mg delayed-release capsules. Esomeprazole Strontium contains the same active moiety (esomeprazole) in a different salt form as found in the branded proton-pump inhibitor Nexium (esomeprazole magnesium) and is a new option for adult patients for the short term treatment of gastroesophageal reflux disease.

17 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 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

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.

18 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

Children exposed to HIV in womb are no more likely to show language delays

Children who were exposed to HIV in the womb whose mothers received anti-HIV medications during pregnancy were no more likely to show language delays by age two than HIV-exposed children whose mothers were not treated during pregnancy, according to a study by University of Kansas Distinguished Professor Mabel L. Rice with researchers at the National Institutes of Health (NIH) and other universities.

16 Aug 2013

Spectrum Pharmaceuticals enters into agreement to acquire Talon Therapeutics

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully-integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that, through a wholly-owned subsidiary, the company entered into an agreement to acquire Talon Therapeutics, Inc., a biopharmaceutical company based in South San Francisco, California, and expects to complete the acquisition within one day.

17 Jul 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

Bristol-Myers Squibb and AstraZeneca announce top line results of Phase 4 SAVOR-TIMI-53 clinical trial of Onglyza

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin).

20 Jun 2013

FDA approves sNDA for SUSTIVA for treatment of HIV-1 infected pediatric patients

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.

4 May 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Gilead Sciences fourth quarter total revenues increase 18% to $2.59 billion

Gilead Sciences, Inc. announced today its results of operations for the fourth quarter and full year 2012.

5 Feb 2013

New public-private partnership will allow Brazil to produce patented ARV for national treatment program

For the first time, Brazil in 2013 will enter into a new type of public-private partnership that allows the nation to produce a generic version of the antiretroviral (ARV) drug atazanavir sulphate, which will be under patent through its producer Bristol-Myers Squibb until 2017, Inter Press Service reports.

8 Dec 2012

Eisai announces FDA acceptance of AcipHex NDA for priority review

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age.

30 Nov 2012

Janssen receives positive opinion from EMA CHMP for ZYTIGA to treat mCRPC

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

19 Nov 2012