Prophylaxis News and Research

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Emergent BioSolutions reports total revenue of $53.9 million for Q1 2014

Emergent BioSolutions Inc. reported total revenue for Q1 2014 of $53.9 million as compared to $43.1 million in 2013. In addition, Q1 2014 net loss was $20.2 million, or $0.55 per share, as compared to a net loss of $8.1 million, or $0.22 per share, in 2013.

9 May 2014

Research may have "major implications" for treatment of urinary tract infections in children

A major new pediatric research study led by a Wayne State University researcher, funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) and published this week in the New England Journal of Medicine (NEJM), has "major implications" for the treatment of urinary tract infections (UTIs) in millions of American children.

8 May 2014

Ligand's total revenues increase 37% to $16.0 million in first quarter 2014

Ligand Pharmaceuticals Incorporated today reported financial results for the three months ended March 31, 2014, and provided an operating forecast and program updates.

7 May 2014

Nanoviricides develops new drug candidates against MERS infection

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6 May 2014

HealthHIV: Nearly 50% of primary care providers lack knowledge about HIV treatment

Primary care providers who provide clinical HIV care (HIV PCPs) are experiencing rising HIV caseloads from newly insured patients under the Patient Protection and Affordable Care Act (PPACA), according to a national survey released today by HealthHIV.

2 May 2014

Study to understand why YMSM place themselves at risk for HIV transmission

The number of new HIV infections in the United States had remained steady in recent years, but rates among urban millennial gay, bisexual, and other young men who have sex with men (YMSM) have steadily increased in the past decade.

29 Apr 2014

Biogen Idec's revenue increases 51% to $2.1 billion in first quarter 2014

Biogen Idec Inc. today reported first quarter 2014 results, including revenue of $2.1 billion, a 51% increase compared to the first quarter of 2013.

23 Apr 2014

FDA grants Orphan Drug Designation to Emergent BioSolutions' BioThrax for PEP of anthrax disease

Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.

21 Apr 2014

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

21 Apr 2014

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Baxter International Inc. today announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111. BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder.

From Baxter International Inc. 16 Apr 2014

Community efforts boost people for HIV testing and reduce new infections

Communities in Africa and Thailand that worked together on HIV-prevention efforts saw not only a rise in HIV screening but a drop in new infections, according to a new study in the peer-reviewed journal The Lancet Global Health.

16 Apr 2014

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).

8 Apr 2014

Study shows administering steroids during cardiac surgery requiring bypass can cause harm

Giving patients steroids at the time of heart surgery does not improve health outcomes and appears to put them at greater risk of having a heart attack in the days following surgery, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.

1 Apr 2014

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

29 Mar 2014

Experimental vaccine for HSV-2 infection reduces rate of viral shedding at 6 months

Updated Phase 1/2a results with GEN-003, a vaccine candidate under development by Genocea Biosciences, Inc. (Nasdaq: GNCA) for the treatment of herpes simplex virus type 2 (HSV-2) infection, showed the experimental vaccine to generate highly significant reductions in both the number of clinical lesion days and rate of viral shedding at six months after the final vaccine dose.

27 Mar 2014

Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Today Biogen Idec announced that Health Canada has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B.

21 Mar 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

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

16 Mar 2014

OPKO Health consolidated revenues increase about 30% to $20.7 million in Q4 2013

OPKO Health, Inc., a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its 2013 fourth quarter and full year ended December 31, 2013.

4 Mar 2014

UNC receives $40M for clinical trials unit devoted to HIV/AIDS treatment, prevention and research

The University of North Carolina at Chapel Hill has received a seven-year, more than $40 million award from the National Institutes of Health for a clinical trials unit that will implement the scientific agendas of five NIH networks devoted to HIV/AIDS treatment, prevention, and cure research.

27 Feb 2014