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RUVICA (ibrutinib) capsules approved for treatment-naïve CLL patients

RUVICA (ibrutinib) capsules approved for treatment-naïve CLL patients

The U.S. Food and Drug Administration has approved IMBRUVICA (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL). [More]
Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Novartis announces FDA approval of Afinitor for progressive, nonfunctional neuroendocrine tumors of GI

Novartis today announced that the United States Food and Drug Administration approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. [More]
Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Baxalta seeks FDA approval for ADYNOVATE to treat children with hemophilia A and for use in surgical settings

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that it has submitted supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration seeking approval for the use of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] to treat children under the age of 12 with hemophilia A and for use in surgical settings. [More]
WRAIR begins Phase 1 clinical trial to evaluate MERS vaccine candidate

WRAIR begins Phase 1 clinical trial to evaluate MERS vaccine candidate

The Walter Reed Army Institute of Research began vaccinations today in a Phase 1 clinical trial to evaluate the safety and immune response of a vaccine candidate to prevent Middle East Respiratory Syndrome (MERS). [More]
Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan plc today announced the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil). [More]
Amgen announces availability of Kyprolis (carfilzomib) in the UK for treatment of relapsed multiple myeloma

Amgen announces availability of Kyprolis (carfilzomib) in the UK for treatment of relapsed multiple myeloma

Amgen today announced that Kyprolis in combination with lenalidomide and dexamethasone is now available in the UK for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. [More]
New evidence highlights benefits and harms of using artificial mesh for surgical repair of vaginal prolapse

New evidence highlights benefits and harms of using artificial mesh for surgical repair of vaginal prolapse

New evidence published today highlights benefits and harms of using artificial mesh when compared with tissue repair in the surgical treatment of vaginal prolapse. Slightly better repair with mesh needs to be weighed carefully against increased risk of harms. [More]
Cherry-flavoured e-cigarette users may be exposed to potentially harmful chemical

Cherry-flavoured e-cigarette users may be exposed to potentially harmful chemical

An analysis of 145 different electronic-cigarette flavoring products reveals that many e-cigarette users may be exposed to a potentially harmful chemical. In a research letter published online today in the peer-reviewed journal Thorax, a research team led by Maciej Goniewicz, PhD, PharmD, of Roswell Park Cancer Institute reports that high levels of the respiratory irritant benzaldehyde were detected in the vapor from most of the flavored nicotine products they studied, with the highest concentrations in vapor from cherry-flavored products. [More]
New case of MERS CoV confirmed in Thailand, other states in WHO South-East Asia Region cautioned to remain vigilant

New case of MERS CoV confirmed in Thailand, other states in WHO South-East Asia Region cautioned to remain vigilant

Thailand today confirmed Middle East respiratory syndrome coronavirus disease in a traveler, the second such case in the country in the last seven months, as WHO cautioned other member states in its South-East Asia Region against the continuing risks and the need to remain vigilant. [More]
Oral drug ivacaftor appears to be safe, beneficial to pre-school children with specific type of cystic fibrosis

Oral drug ivacaftor appears to be safe, beneficial to pre-school children with specific type of cystic fibrosis

The oral drug ivacaftor appears to be safe and could be beneficial to young children between the ages of 2 and 5 with a specific type of cystic fibrosis, according to new research published in The Lancet Respiratory Medicine journal. [More]
American College of Cardiology to honor LA BioMed researcher with Distinguished Teacher Award

American College of Cardiology to honor LA BioMed researcher with Distinguished Teacher Award

John Michael Criley, MD, a Los Angeles Biomedical Research Institute researcher, will receive the 2016 Distinguished Teacher Award from the American College of Cardiology on April 4 at the organization's 65th Annual Scientific Session in Chicago, IL. [More]
Music therapy in conjunction with standard rehabilitation benefits COPD patients

Music therapy in conjunction with standard rehabilitation benefits COPD patients

Patients with Chronic Obstructive Pulmonary Disease (COPD) and other chronic respiratory disorders who received music therapy in conjunction with standard rehabilitation saw an improvement in symptoms, psychological well-being and quality of life compared to patients receiving rehabilitation alone, according to a new study by researchers at The Louis Armstrong Center of Music and Medicine at Mount Sinai Beth Israel (MSBI). [More]
Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta announces initial results from ADYNOVATE Phase 3 trial for treatment of hemophilia patients

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. [More]
Lilly, Merck announce another immuno-oncology collaboration

Lilly, Merck announce another immuno-oncology collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types. [More]
Boehringer Ingelheim begins SENSCIS study to investigate safety, efficacy of nintedanib in patients with SSc-ILD

Boehringer Ingelheim begins SENSCIS study to investigate safety, efficacy of nintedanib in patients with SSc-ILD

Boehringer Ingelheim announced today that the first person has been enrolled in the SENSCIS (Safety and Efficacy ofNintedanib in Systemic SClerosIS) study. [More]
Kanuma approved as first treatment for patients with LAL deficiency

Kanuma approved as first treatment for patients with LAL deficiency

Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. [More]
XARELTO reduces rates of major bleeding, recurrent blood clots in people with deep vein thrombosis

XARELTO reduces rates of major bleeding, recurrent blood clots in people with deep vein thrombosis

Janssen Pharmaceuticals, Inc. and its development partner, Bayer HealthCare, today announced the results from their real-world study XALIA showing that, in people with deep vein thrombosis (DVT), the rates of major bleeding and recurrent blood clots for XARELTO (rivaroxaban) in routine clinical practice were generally consistent with those observed in Phase 3 research. [More]
Ibrutinib more effective than traditional chemotherapy in older untreated patients with CLL

Ibrutinib more effective than traditional chemotherapy in older untreated patients with CLL

A multi-center, international, randomized, Phase III study of older untreated patients with chronic lymphocytic leukemia (CLL) demonstrated that ibrutinib, a kinase inhibitor, is significantly more effective than traditional chemotherapy with chlorambucil. [More]
FDA grants approval for Empliciti (elotuzumab) to treat patients with multiple myeloma

FDA grants approval for Empliciti (elotuzumab) to treat patients with multiple myeloma

Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. [More]
Opdivo (nivolumab) approved to treat patients with advanced renal cell carcinoma

Opdivo (nivolumab) approved to treat patients with advanced renal cell carcinoma

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. [More]
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