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Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen Research & Development, LLC has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

7 Jun 2015

New study aims to find the genetic causes of substance addiction

A new study aims to find the genetic causes specific symptoms of substance addiction, which could lead to a more nuanced way of looking at substance abuse, and ways to treat it.

5 Jun 2015

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

5 Jun 2015

Researchers identify immune system marker that drives therapy-resistant prostate cancer

You are a patient who has just been treated for a serious illness but neither you nor your doctor knows how likely it is that you -- in comparison with other patients -- will actually be helped by the treatment. This is often the situation with prostate cancer, one of the deadliest and most highly prevalent cancers. While hormone therapy can help, patient responses vary widely, and it's still unclear why some types of prostate cancer seem to be resistant to the therapy.

5 Jun 2015

Scientists identify new agent to combat tuberculosis

According to figures of the World Health Organization, some 8.7 million people contracted tuberculosis in 2012 and this disease is fatal for approximately 1.3 million people throughout the world each year. One of the main problems is that the tuberculosis pathogens have become resistant to the antibiotics used to fight them.

5 Jun 2015

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

Today, Pharmacyclics LLC, an AbbVie company, announced that ibrutinib (IMBRUVICA) improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL, respectively) in the final analysis of the Phase III RESONATE™-2 (PCYC-1115) trial.

5 Jun 2015

‘Unsurpassed protein SEC’: OMNISEC delivers accurate information with minimal sample

In a new webinar ‘Unsurpassed protein SEC using the latest innovation in advanced detection, OMNISEC’, experts from Malvern Instruments demonstrate how the OMNISEC size exclusion chromatography (SEC) system supports efficient screening early in the drug development pipeline by enabling precise characterization with minimal sample volumes.

5 Jun 2015

Biochemists devise snappy new technique for blueprinting cell membrane proteins

Biochemists from Trinity College Dublin have devised a new technique that will make the difficult but critical job of blueprinting certain proteins considerably faster, cheaper and easier.

5 Jun 2015

Actavis receives FDA approval to market NATRELLE INSPIRA round gel-filled textured breast implants

Actavis plc, which recently completed the acquisition of Allergan, Inc., today announced that the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA round gel-filled textured breast implants, offering women undergoing reconstruction, augmentation or revision surgery another breast shaping option for a customized result.

5 Jun 2015

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21").

4 Jun 2015

Keeping blood sugar levels under control can help protect hearts from diabetes-related damage

Day in and day out, for years on end, millions of people with diabetes prick their fingers to test their blood sugar level. And many may wonder if all the careful eating, exercise and medication it takes to keep those levels under control is really worth it.

4 Jun 2015

EMA, ESMO and RCE joint workshop focuses on rare cancers and chordoma

To date, there is no drug approved for medical therapy of chordoma patients. Supporting research for chordoma (a very rare cancer arising from the skull base or the spine and affecting only one person in a million per year) was the focus of talks that took place on 30 April 2015 at the European Medicines Agency in London. The workshop was attended by patients, oncologists, pathologists, regulators, statisticians and industry representatives.

4 Jun 2015

New strategy involving three-pronged approach may keep lung cancer aside

Lung cancer is the leading cause of cancer death worldwide, responsible for some 1.59 million deaths a year. That figure is due, in part, to the fact that lung cancer often returns after what seems at first to be successful treatment. However, the recurring cancer is often resistant to the chemotherapy and other drugs that originally drove it into remission.

4 Jun 2015

Scientists uncover why some people more prone to major depression

Scientists are beginning to unwrap the biology behind why some people are more prone to major depression and other psychiatric disorders than others when experiencing stressful life events. The researchers found that cellular activity in response to stress hormone receptor activation differs from individual to individual.

4 Jun 2015

LMU cardiologists study new approach to inhibit atherosclerotic plaque-induced platelet activation

Blood clots often form when lipid-rich plaques on the inner surface of arteries rupture and platelets aggregate at the site of injury. Cardiologists from Ludwig-Maximilians-Universitaet in Munich have now compared the effects of two new platelet aggregation inhibitors.

4 Jun 2015

Researchers developing probe wire to better understand causes of degenerative brain diseases

Researchers are developing a tiny wire that will speed up the discovery of new drugs and could one day unlock the mysteries of illnesses such as Alzheimer's or Lou Gehrig's disease.

4 Jun 2015

New study suggests that IDH1 gene may be prognostic marker for anaplastic astrocytoma

New findings suggest that a gene called IDH1 might be prognostic marker for a rare form of brain cancer. Patients in this study who had a mutated IDH gene lived an average of 7.9 years after diagnosis versus 2.8 years for patients with unaltered IDH.

4 Jun 2015

AbbVie selects Halozyme's ENHANZE platform to augment their development pipeline

Halozyme Therapeutics, Inc. today announced a global collaboration and license agreement with AbbVie to develop and commercialize products combining proprietary AbbVie compounds with Halozyme's ENHANZE platform.

3 Jun 2015

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

A single dose of an FDA-approved intravenous nutrition source may be able to significantly reduce the toxicity and increase the bioavailability of platinum-based cancer drugs, according to a study by Carnegie Mellon University biologists published in Scientific Reports.

3 Jun 2015

Hi-Tech Pharmaceuticals signs definitive agreement to acquire FormuTech Nutrition

Hi-Tech Pharmaceuticals, a leading global provider of Sports Nutrition products, Contract Manufacturing, and FormuTech Nutrition, one of the fastest-growing Sports Nutrition companies in the United States, today announced that they have entered into a definitive agreement in which Hi-Tech has agreed to acquire FormuTech.

3 Jun 2015

Drugs News and Research

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

New study aims to find the genetic causes of substance addiction

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Researchers identify immune system marker that drives therapy-resistant prostate cancer

Scientists identify new agent to combat tuberculosis

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

‘Unsurpassed protein SEC’: OMNISEC delivers accurate information with minimal sample

Biochemists devise snappy new technique for blueprinting cell membrane proteins

Actavis receives FDA approval to market NATRELLE INSPIRA round gel-filled textured breast implants

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Keeping blood sugar levels under control can help protect hearts from diabetes-related damage

EMA, ESMO and RCE joint workshop focuses on rare cancers and chordoma

New strategy involving three-pronged approach may keep lung cancer aside

Scientists uncover why some people more prone to major depression

LMU cardiologists study new approach to inhibit atherosclerotic plaque-induced platelet activation

Researchers developing probe wire to better understand causes of degenerative brain diseases

New study suggests that IDH1 gene may be prognostic marker for anaplastic astrocytoma

AbbVie selects Halozyme's ENHANZE platform to augment their development pipeline

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

Hi-Tech Pharmaceuticals signs definitive agreement to acquire FormuTech Nutrition

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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