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Pfizer receives FDA approval for Elelyso to treat Type 1 Gaucher disease

The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.

2 May 2012

Antibiotic effective for plague gets FDA nod

Federal regulators – The Food and Drugs Administration (FDA), have approved use of an antibiotic to treat plague, an extremely rare, sometimes-fatal bacterial infection.

30 Apr 2012

Some public health advocates disagree with Indian government's decision to roll out pentavalent vaccines, IPS reports

"Ignoring widespread concern over the safety, efficacy and cost of pentavalent vaccines" -- which provide protection against diphtheria, pertussis, tetanus, hepatitis B and haemophilus influenza type b (Hib) -- "India's central health ministry has, this month, approved inclusion of the prophylactic cocktail in the universal immunization program in seven of its provinces," Inter Press Service reports.

30 Apr 2012

CR2 announces acquisition of CardioReady

CR2, LLC announced the acquisition of CardioReady, a pioneer in Cardiac Emergency Response and Automated External Defibrillator (AED) deployment since 2004. Using a patented suite of solutions, CardioReady assists organizations across the United States in protecting the lives of their customers, employees, and other visitors to their sites against Sudden Cardiac Arrest (SCA) – the leading cause of death in America.

30 Apr 2012

FDA approves Levaquin for plague

The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

30 Apr 2012

Enrollment complete in Zalicus Synavive Phase 2b clinical trial for rheumatoid arthritis

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA).

30 Apr 2012

Pharmanest commences SHACT Phase I pharmacokinetic study

Karolinska Development: Pharmanest AB today announced that the first patient has been dosed in an open label pharmacokinetic study with its drug candidate SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion.

30 Apr 2012

VIVUS receives FDA approval for Stendra to treat erectile dysfunction

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

30 Apr 2012

Five U.S. federal agencies provide significant contributions each year to global health R&D

A new report that the United States government is the largest funder of global health research and development (R&D) in the world, investing $12.7 billion over the past 10 years in the creation of new vaccines, drugs, diagnostics, and other products for neglected diseases of the developing world. That funding, according to the report, helped lead to the development of more than half of the 45 new health products in the last decade that have been used to save lives around the world.

30 Apr 2012

FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.

30 Apr 2012

Cameron Health's subcutaneous ICD for sudden cardiac arrest receives FDA advisory panel approval

Cameron Health, Inc., a pioneer in the development, manufacture and distribution of next generation implantable cardioverter defibrillators (ICDs), announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD System for the treatment of sudden cardiac arrest (SCA).

27 Apr 2012

Accuray launches Prostate Advances in Comparative Evidence Study

Accuray Incorporated, the premier radiation oncology company, announced today the launch of the Prostate Advances in Comparative Evidence (PACE) Study, an international, multi-center, randomized study to compare CyberKnife® Stereotactic Body Radiation Therapy (SBRT), da Vinci assisted and manual laparoscopic surgery and conventionally fractionated intensity modulated radiation therapy (IMRT), for the treatment of localized prostate cancer.

27 Apr 2012

FDA ODAC to review Onyx’s NDA for carfilzomib

Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012.

27 Apr 2012

Positive top-line results from Shire’s Vyvanse Phase 2 study on binge eating disorder

Shire plc, the global specialty biopharmaceutical company, today announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) in adults with binge eating disorder.

27 Apr 2012

Novartis receives FDA approval for Afinitor to treat renal angiomyolipomas caused by TSC

The U.S. Food and Drug Administration approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex.

27 Apr 2012

CytRx commences INNO-206 Phase 2 clinical trial for pancreatic cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies.

26 Apr 2012

IMPAKT 2012 breast cancer conference to focus on four major areas

"Basic science and clinical medicine move at different pace because they follow different paths. Both however aim at improving strategies to manage cancer patients. We need to efficiently translate the good things from basic science and efficiently implement them in the clinic."

26 Apr 2012

Robot assisted laparoscopic radical prostatectomy better than other surgical techniques

Outcomes from use of a robot to assist surgeons in removal of a cancerous prostate are at least as good, if not better, than the other two techniques used for a radical prostatectomy -- open or laparoscopic surgery -- according to a large meta analysis led by researchers at NewYork-Presbyterian/Weill Cornell.

26 Apr 2012

InDex Pharmaceuticals granted U.S. patent for novel treatment of steroid-resistant inflammation

InDex Pharmaceuticals today announced that it has been granted a patent by the United States Patent and Trademark Office. The patent provides additional protection for the use of Kappaproct® and additional DNA-based immunomodulatory sequences (DIMS) for the treatment of steroid-resistant inflammatory diseases including inflammatory bowel disease, rheumatoid arthritis, psoriasis, asthma, emphysema and chronic obstructive pulmonary disease.

26 Apr 2012

ASIA honors SCI researchers with 2012 Apple Award

American Spinal Injury Association (ASIA) has awarded its 2012 Apple Award to the article by Mark Nash, PhD, et al, entitled, "Safety, tolerance, and efficacy of extended-release niacin monotherapy for treating dyslipidemia risks in persons with chronic tetraplegia: a randomized multicenter controlled trial."

26 Apr 2012

Efficacy News and Research

Pfizer receives FDA approval for Elelyso to treat Type 1 Gaucher disease

Antibiotic effective for plague gets FDA nod

Some public health advocates disagree with Indian government's decision to roll out pentavalent vaccines, IPS reports

CR2 announces acquisition of CardioReady

FDA approves Levaquin for plague

Enrollment complete in Zalicus Synavive Phase 2b clinical trial for rheumatoid arthritis

Pharmanest commences SHACT Phase I pharmacokinetic study

VIVUS receives FDA approval for Stendra to treat erectile dysfunction

Five U.S. federal agencies provide significant contributions each year to global health R&D

FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction

Cameron Health's subcutaneous ICD for sudden cardiac arrest receives FDA advisory panel approval

Accuray launches Prostate Advances in Comparative Evidence Study

FDA ODAC to review Onyx’s NDA for carfilzomib

Positive top-line results from Shire’s Vyvanse Phase 2 study on binge eating disorder

Novartis receives FDA approval for Afinitor to treat renal angiomyolipomas caused by TSC

CytRx commences INNO-206 Phase 2 clinical trial for pancreatic cancer

IMPAKT 2012 breast cancer conference to focus on four major areas

Robot assisted laparoscopic radical prostatectomy better than other surgical techniques

InDex Pharmaceuticals granted U.S. patent for novel treatment of steroid-resistant inflammation

ASIA honors SCI researchers with 2012 Apple Award

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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