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AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

AVEO Oncology and Astellas Pharma Inc. today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC).

29 Sep 2012

Cameron Health receives FDA approval for subcutaneous implantable defibrillator system

The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart.

29 Sep 2012

BioTime forms new wholly owned subsidiary

BioTime, Inc., an Alameda-based company engaged in research and development of innovative new products in the field of regenerative medicine utilizing stem cells and related technology, announced today that it has formed a new wholly owned subsidiary, BioTime Acquisition Corporation, to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine.

29 Sep 2012

Abbott receives FDA approval for Humira to treat ulcerative colitis

The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.

29 Sep 2012

Researchers discover way to detect and eliminate troublemaking stem cells

Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells.

28 Sep 2012

Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced that it has amended and expanded the scope of the protocol PV-10-LC-01, "A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant."

28 Sep 2012

EC approves Janssen’s DACOGEN for treatment of de novo acute myeloid leukaemia

Janssen-Cilag International NV announced today that the European Commission has approved the marketing authorisation for DACOGEN(decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

28 Sep 2012

Lessons on the journey to commercialisation

One of the Asia Pacific region’s best known biotech leaders, Dr Greg Collier, says successful commercialisation of a new drug or therapy takes, “discipline, a strong set of nerves and a stroke of luck.”

28 Sep 2012

Fear hard to extinguish from the teenage brain

A new study by Weill Cornell Medical College researchers shows that adolescents' reactions to threat remain high even when the danger is no longer present. According to researchers, once a teenager's brain is triggered by a threat, the ability to suppress an emotional response to the threat is diminished which may explain the peak in anxiety and stress-related disorders during this developmental period.

28 Sep 2012

Conditionally reprogrammed cells help identify effective therapy for HPV-positive RRP

Using a newly discovered cell technology, Georgetown University Medical Center researchers were able to identify an effective therapy for a patient with a rare type of lung tumor. The single case study, reported in the September 27 issue of New England Journal of Medicine, provides a snapshot of the new technology's promising potential; however, researchers strongly caution that it could be years before validation studies are completed and regulatory approval received for its broader use.

28 Sep 2012

Researchers solve key part of muscle regeneration mystery

Working with mice, Johns Hopkins researchers have solved a key part of a muscle regeneration mystery plaguing scientists for years, adding strong support to the theory that muscle mass can be built without a complete, fully functional supply of muscle stem cells.

28 Sep 2012

Boston Scientific receives CE MARK approval for Vercise DBS to treat Parkinson's

Boston Scientific Corporation received CE Mark approval for use of its Vercise Deep Brain Stimulation (DBS) System for the treatment of Parkinson's disease.

28 Sep 2012

Incarcerated patients with chronic HCV likely to achieve sustained viral response

Incarcerated patients with chronic hepatitis C virus (HCV) infection are just as likely to respond to treatment for the disease as patients in the community, according to findings published in the October issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases.

28 Sep 2012

Japanese MHLW approves Sosei’s Seebri inhalation capsules to treat COPD

Sosei Group Corporation confirms the information released today by Novartis that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg administered through the Breezhaler device, as a once-daily, long-term, inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in chronic obstructive pulmonary disease.

28 Sep 2012

Two-part ACR guidelines on gout

Gout is one of the most common forms of inflammatory arthritis, affecting nearly 4% of adult Americans. Newly approved guidelines that educate patients in effective methods to prevent gout attacks and provide physicians with recommended therapies for long-term management of this painful disease are published in Arthritis Care & Research, a peer-reviewed journal of the American College of Rheumatology (ACR).

28 Sep 2012

ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

ARIAD Pharmaceuticals, Inc. today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA).

28 Sep 2012

Life Technologies receives FDA clearance for OpTmizer CTS T-cell expansion media

Life Technologies Corporation today announced it has received FDA 510(k) clearance for its OpTmizer CTS T-Cell Expansion Tissue Culture Medium – a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials.

28 Sep 2012

Bayer HealthCare receives FDA approval for Stivarga to treat colorectal cancer

The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).

28 Sep 2012

Early, intensive therapy with adalimumab can help treat rheumatoid arthritis

Early, intensive therapy with a biotechnologically produced medication can provide significantly faster pain relief for patients with rheumatic joint inflammation. Damage to joints can also be reduced when the medication is applied right at the beginning of the illness.

27 Sep 2012

Key bacterial protein structures reveal one of the biochemical secrets behind multi-drug tolerance

The structures of key bacterial proteins have revealed one of the biochemical secrets that enables bacteria to outwit antibiotics.

27 Sep 2012

Therapy News and Research

AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

Cameron Health receives FDA approval for subcutaneous implantable defibrillator system

BioTime forms new wholly owned subsidiary

Abbott receives FDA approval for Humira to treat ulcerative colitis

Researchers discover way to detect and eliminate troublemaking stem cells

Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

EC approves Janssen’s DACOGEN for treatment of de novo acute myeloid leukaemia

Lessons on the journey to commercialisation

Fear hard to extinguish from the teenage brain

Conditionally reprogrammed cells help identify effective therapy for HPV-positive RRP

Researchers solve key part of muscle regeneration mystery

Boston Scientific receives CE MARK approval for Vercise DBS to treat Parkinson's

Incarcerated patients with chronic HCV likely to achieve sustained viral response

Japanese MHLW approves Sosei’s Seebri inhalation capsules to treat COPD

Two-part ACR guidelines on gout

ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

Life Technologies receives FDA clearance for OpTmizer CTS T-cell expansion media

Bayer HealthCare receives FDA approval for Stivarga to treat colorectal cancer

Early, intensive therapy with adalimumab can help treat rheumatoid arthritis

Key bacterial protein structures reveal one of the biochemical secrets behind multi-drug tolerance

The Critical Role of Sample Storage in Drug Discovery and Development

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

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